Clinical Operations Remote Jobs in West Virginia (US)
This page tracks remote clinical operations openings that are location-eligible for West Virginia.
This page tracks remote clinical operations openings that are location-eligible for West Virginia.
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CenterWell Pharmacy provides convenient, safe, reliable pharmacy services and is committed to excellence and quality. Through our home delivery and over-the-counter fulfillment services, specialty, and retail pharmacy locations, we provide customers simple, integrated solutions every time. Cares for patients with chronic and complex illnesses. Offers personalized clinical and educational services to improve health outcomes and drive superior medication adherence. CenterWell, a Humana company, creates experiences that put patients at the center. As the nation’s largest provider of senior-focused primary care, one of the largest providers of home health services, and the fourth largest pharmacy benefit manager, CenterWell is focused on whole-person health by addressing the physical, emotional, and social wellness of our patients. Part of Humana Inc. (NYSE: HUM). Offers stability, industry-leading benefits, and opportunities to grow yourself and your career. Employs more than 30,000 clinicians committed to putting health first. Provides flexible scheduling options, clinical certifications, leadership development programs, and career coaching.
Role Description The Clinical Operations Strategy Principal designs and implements initiatives that optimize clinical operations and enhance care delivery across aligned area(s), or the organization. This role will report to the Clinical Operations Strategy Principal. The Clinical Operations Strategy Principal is a senior individual contributor responsible for advancing and executing high-impact strategic initiatives across CenterWell's Value-Based Care Enablement / IPA business. Serving as a trusted advisor to senior leadership, the Principal leads the development of forward-looking business models and go-to-market strategies, ensuring the organization is positioned to scale innovative offerings and remain competitive in a rapidly evolving healthcare landscape. - Serves as a trusted advisor to senior leadership, driving the development of segment-level strategies and ensuring successful execution across complex, cross-functional environments. - Operates as an advanced subject matter expert across clinical quality, business operations, and technology to support value-based care enablement. - Leads highly complex initiatives from concept through scaled execution, applying deep business acumen, structured problem-solving, and innovative solution design to drive measurable improvements in financial performance, operational efficiency, and membership growth. - Requires a leader who thrives in ambiguity, exercises independent judgment, and influences outcomes across multiple functions and stakeholders. Qualifications - Bachelor's degree - 10+ years of experience in healthcare or product strategy - 2-5 years of project/people leadership - Demonstrated ability to lead highly complex, cross-functional initiatives with significant business and financial impact - Strong financial acumen, including experience with: - P&L ownership - Pricing strategy - ROI modeling - Performance management - Proven ability to influence senior stakeholders and operate effectively in highly matrixed environments - Exceptional strategic thinking, structured problem-solving, and analytical capabilities - Ability to operate independently with a high degree of autonomy, sound judgment, and accountability - Highly effective communicator and collaborative leader, with a track record of aligning diverse stakeholders and driving decisions - Execution-oriented with strong program leadership and organizational capabilities, and a deep understanding of operational impact - Proactive, resourceful self-starter who thrives in ambiguity and fast-paced environments Requirements - To ensure Home or Hybrid Home/Office employees’ ability to work effectively, the self-provided internet service must meet the following criteria: - At minimum, a download speed of 25 Mbps and an upload speed of 10 Mbps is required; wireless, wired cable or DSL connection is suggested. - In certain roles, the minimum recommended internet speed required by Humana may not be sufficient for business needs. Humana reserves the right to require associates to upgrade their internet service if necessary. - Work from a dedicated space lacking ongoing interruptions to protect member PHI / HIPAA information. - Occasional travel to Humana's offices for training or meetings may be required. Benefits - Competitive benefits that support whole-person well-being. - Medical, dental and vision benefits. - 401(k) retirement savings plan. - Time off (including paid time off, company and personal holidays, paid parental and caregiver leave). - Short-term and long-term disability. - Life insurance and many other opportunities.
UVVC is a leading provider of comprehensive vein and vascular care with over 45 clinics across Arizona, Chicago, Colorado, Florida, Georgia, Texas, and expanding. Our mission is to revolutionize vascular care by delivering an all-inclusive clinic experience that addresses every aspect of lower extremity vein, vascular, and wound conditions. United Vein & Vascular Centers (UVVC) is distinguished by its innovative approach to diagnosing and treating a variety of vascular conditions that affect the pelvis and lower extremities. With a team of committed specialists, cutting-edge medical technology, and a patient-centric approach that emphasizes minimally invasive procedures, UVVC ensures superior care and optimal outcomes for its patients.
Role Description The Regional Clinical Program Manager is responsible for the development, maintenance, implementation, and oversight of standardized, competency-based onboarding, training, professional development, and clinical readiness programs for Clinical Technologists (CTs) and Licensed Practical Nurses (LPNs) within clinic-based vascular service lines. This role serves as a clinical resource and dotted-line clinical leader to Clinical Technologist and LPN Leads within designated Markets, supporting workforce development, competency, clinical readiness, standardized workflows, and implementation of enterprise clinical initiatives. This position is open to remote workstyle if the candidate is located in our current operating markets. This is a HIGH TRAVEL position. Responsibilities - Determine the initial and ongoing clinical skills, education, training, and competency needs for Clinical Technologists (CTs) and Licensed Practical Nurses (LPNs) to consistently deliver high-quality patient care. - Utilize a variety of instructional methods and media to deliver education and training to CTs and LPNs, including but not limited to training manuals, training checklists, flowcharts, job aids, newsletters, videos, competency tools, and Learning Management System content. - Work collaboratively with Information Technology, EHR, and clinical leadership to create and update clinical training materials, workflow guidance, job aids, and videos related to clinical documentation and workflows. - Act as a super user and clinical resource for technology, clinical documentation, and clinical workflows. - Develop and implement education initiatives, including onboarding, competency validation, annual competencies, remediation, and just-in-time training based on needs assessments, workflow changes, new products or technology, incident reporting trends, patient experience feedback, employee feedback, and clinical performance opportunities. - Serve as the clinical program lead for Clinical Technologists (CTs) and Licensed Practical Nurses (LPNs) within assigned clinic-based vascular service lines, supporting onboarding, competency development, workforce readiness, coaching, and standardization of clinical workflows in partnership with clinic, operational, physician, and clinical leadership. - Serve as a role model, mentor, and clinical resource while maintaining competency in CT and LPN workflows, standards, and responsibilities. - Develop CT/LPN preceptors and Clinical Technologist and LPN Leads within designated Markets. - Partner with Clinical Technologist and LPN Leads in designated Markets to support and monitor: - Completion of required onboarding, web-based and in-person clinical training, skills signoffs, and competency validation. - Clinical readiness activities, environmental rounds, identification of trends, follow-up on corrective actions, and preparation for accreditation, quality, risk, and safety-related readiness activities. - Implementation and sustainment of enterprise clinical initiatives, workflows, and standards of care. - Compliance with clinical policies, procedures, documentation expectations, and standardized workflows. - Participate in the recruitment, onboarding, hiring, development, and retention of CTs and LPNs in partnership with clinical and operational leadership. - Maintain knowledge of applicable state and federal regulations and laws impacting CT and LPN scope of practice. - Partner with clinical, quality, risk, safety, and operational leadership to support clinical readiness, sustainment, and preparation for accreditation, patient safety, infection prevention, quality initiatives, and regulatory standards within clinic-based vascular service lines. - Seek opportunities for continuous improvement and collaborate with physician, clinical, and operational leadership on implementation of quality improvement, patient safety, and clinical standardization initiatives. - Provide reporting to clinical leadership regarding key aspects of CT/LPN onboarding, competency, clinical readiness, workforce development, and program performance. - Serve on committees, work groups, and enterprise initiatives as assigned. Culture - Demonstrate and promote a work culture committed to UVVC’s Core Values: Understanding, Nurturing, Ingenuity, Trust, Excellence, and Diversity. - Demonstrate behaviors that are consistent with UVVC’s Standards of Conduct as outlined in our employee handbook. - Maintain the confidentiality and security of Protected Health Information (PHI) in accordance with UVVC policies, the Health Insurance Portability and Accountability Act (HIPAA), and other applicable laws and regulations. PHI is a top priority of our organization. - Other duties as assigned. Qualifications - Registered Nurse (RN) or LPN with current state or multi-state licensure. - At least 5 years recent clinical experience. - Basic Life Support (BLS) for Healthcare Provider required. - Prior clinical education, onboarding or competency-based training experience preferred. - Prior experience in vein, vascular, ambulatory, outpatient procedural, or clinic-based care settings preferred. - Multi-state and/or multi-site experience a plus. - A deep understanding of clinical processes and healthcare environments. - Knowledge of adult learning theories and principles. - Knowledge of infection control standards. - Knowledge of quality improvement, patient safety, infection prevention, and clinical standardization concepts. - Excellent written and verbal communication skills. - Proficient in the use of computer applications, including Microsoft Word, PowerPoint, Excel, Outlook and EHR systems. - Ability to work well independently and within a team structure. - Critical thinking skills and the ability to exercise sound judgement when making decisions. - Ability to inspire and motivate others in a team environment, both virtually and in-person. - Dependable; able to meet reliable attendance and punctuality standards for the role. - Must be able and willing to travel locally and regionally on a regular basis. - Must be able to provide proof of acceptable auto policy liability coverage limits of $100k for bodily injury per person, $300k for bodily injury per accident, and $50k for property damage. Company Description UVVC, is a leading provider of comprehensive vein and vascular care with over 60 clinics across Arizona, Illinois, Colorado, Florida, Georgia, Texas, and expanding. Our mission is to revolutionize vascular care by delivering an all-inclusive clinic experience that addresses every aspect of lower extremity vein, vascular, and wound conditions. United Vein & Vascular Centers (UVVC) is distinguished by its innovative approach to diagnosing and treating a variety of vascular conditions that affect the pelvis and lower extremities. With a team of committed specialists, cutting-edge medical technology, and a patient-centric approach that emphasizes minimally invasive procedures, UVVC ensures superior care and optimal outcomes for its patients.
Indiana University Health is the largest health system in Indiana with nearly 40,000 team members, 15 hospitals and $8.64 billion in operating revenue. The system’s programs in cancer, cardiovascular, neuroscience, orthopedics, pediatrics and transplants have received national recognition for quality patient care. IU Health, in partnership with the Indiana University School of Medicine, brings together highly skilled physicians, researchers, and educators into close collaboration to provide world-class care for children and adults and improve the health of patients and communities across Indiana. Indiana University Health is dedicated to a fair hiring process and is committed to equal opportunity and nondiscrimination for all individuals, regardless of age, color, disability, ethnicity, marital status, national origin, race, religion, gender identity, expression, sexual orientation, or veteran status. IU Health is invested in the lives of Hoosiers, leading the transformation of healthcare to make Indiana one of the nation’s healthiest states. As an employee of Indiana’s most comprehensive health system, we are excited to support team members who are inspired by challenging and meaningful work for the good of every patient.
Role Description We are looking for team members who are passionate about challenging and significant work for the good of every patient. We are searching for individuals who are compassionate, serve with a purpose, are dedicated to supporting their team, and who seek excellence every day. Sound like a perfect match? Apply now - we can't wait to hear from you! Schedule - Monday-Friday 7:30am-5pm Work Location - Remote Primary Responsibilities - Oversee patient flow from point of entry to destination and ensure timely, accurate and professional services. - Responsible for timely and accurate resolution of patients’ accounts. - Obtain specific information to generate accurate financial and demographic records, insurance verification, prior authorization, and coordination of benefits. - Communicate with payers and patients to achieve accurate financial information. - Accurate registration of patients, scheduling recurring appointments, answering incoming calls and directing patients and visitors appropriately. - Participate in operational aspects of the department and maintain performance improvement activities as required. - Participate in all infection control, department equipment training, regulatory compliance, organizational safety and fire safety programs. - Order, distribute and maintain designated and appropriate inventory of department related supplies. - Assigned higher complexity tasks than those expected from Associate-Rehabilitation Clinical Support and held to higher productivity and quality standards. Qualifications - High School Diploma/GED is required. - Two years’ experience in Rehabilitation Services or similar job duties (patient registration, insurance, scheduling) required. - Ability to work within a team and maintain collaborative relationships. - Basic proficiency in MS Office (Word, PowerPoint, Excel, TEAMS). - High level of interpersonal and problem-solving skills. - Ability to take initiative and meet objectives. - Effective written and verbal communication skills. - Excellent working knowledge of the Associate of Clinical Support Job Duties. Benefits - 401(K) retirement savings with employer match - Tuition reimbursement - Employee Assistance Program – Counseling at no cost to you - Healthy Results - Participation in our team member wellness programs award points that contribute toward a biweekly financial incentive in your paycheck! The more you participate, the more you earn!
Indiana University Health is the largest health system in Indiana with nearly 40,000 team members, 15 hospitals and $8.64 billion in operating revenue. The system’s programs in cancer, cardiovascular, neuroscience, orthopedics, pediatrics and transplants have received national recognition for quality patient care. IU Health, in partnership with the Indiana University School of Medicine, brings together highly skilled physicians, researchers, and educators into close collaboration to provide world-class care for children and adults and improve the health of patients and communities across Indiana. Indiana University Health is dedicated to a fair hiring process and is committed to equal opportunity and nondiscrimination for all individuals, regardless of age, color, disability, ethnicity, marital status, national origin, race, religion, gender identity, expression, sexual orientation, or veteran status. IU Health is invested in the lives of Hoosiers, leading the transformation of healthcare to make Indiana one of the nation’s healthiest states. As an employee of Indiana’s most comprehensive health system, we are excited to support team members who are inspired by challenging and meaningful work for the good of every patient.
Role Description We are looking for team members who are passionate about challenging and significant work for the good of every patient. We are searching for individuals who are compassionate, serve with a purpose, are dedicated to supporting their team, and who seek excellence every day. Schedule: PRN *As Needed* (24-30 hours max per week) Monday-Friday: 7:30am-5:00pm Work Location: Remote Primary Responsibilities: - Oversee patient flow from point of entry to destination and ensure timely, accurate and professional services. - Responsible for timely and accurate resolution of patients’ accounts. - Obtain specific information to generate accurate financial and demographic records, insurance verification, prior authorization, and coordination of benefits. - Communicate with payers and patients to achieve accurate financial information. - Accurate registration of patients, scheduling recurring appointments, answering incoming calls, and directing patients and visitors appropriately. - Participate in operational aspects of the department and maintain performance improvement activities as required. - Participate in all infection control, department equipment training, regulatory compliance, organizational safety and fire safety programs. - Order, distribute and maintain designated and appropriate inventory of department related supplies. - Adhere to departmental productivity, quality and service standards in support of operational goals. Qualifications - High School Diploma/GED is required. Requirements - 0-3 years Customer Service/Medical experience desired. - Minimum one-year medical office experience or combination of extensive customer service work experience and education in insurance verification, patient registration and medical terminology preferred. - Requires basic proficiency in MS Office (Word, PowerPoint, Excel, TEAMS). Benefits - Access to diverse opportunities to learn and develop in meaningful ways. - Advanced clinical training and leadership development. - Promotion opportunities and cross training development.
This opportunity is available through a leading AI-driven work platform.
Role Description We are sharing a specialised part-time consulting opportunity for experienced healthcare professionals across clinical practice, nursing, healthcare administration, compliance, pharmacy, health information management, medical billing, revenue cycle, health economics, and healthcare data analysis. This role supports current and upcoming remote consulting opportunities focused on AI-assisted healthcare workflow training, clinical pathway documentation, operational process evaluation, regulatory and compliance review, and high-quality project execution. Selected professionals will translate real-world healthcare workflows, clinical decision-making, and operational processes into structured examples, review AI-generated healthcare outputs, and provide detailed feedback based on clinical, operational, regulatory, or administrative expertise. Key Responsibilities - Healthcare Workflow Documentation - Document end-to-end healthcare workflows involving patient care pathways, diagnosis, treatment selection, hospital operations, clinical coordination, pharmacy workflows, compliance processes, revenue cycle, or administrative decision-making. - Create structured examples that reflect real-world healthcare judgment, evidence-based practice, operational constraints, and process sequencing. - Translate clinical and healthcare operations expertise into clear workflow steps, decision frameworks, and task-based deliverables. - Support work across multiple healthcare specialties depending on professional background, credentials, and project needs. - Clinical, Operational & Compliance Review - Review and refine AI-generated clinical analyses, healthcare workflow outputs, operational recommendations, or compliance-related content. - Evaluate outputs for accuracy, safety, completeness, regulatory alignment, and practical usefulness. - Validate content against clinical guidelines, quality standards, healthcare regulations, documentation expectations, and operational best practices. - Identify missing steps, unsafe recommendations, workflow gaps, regulatory concerns, incomplete reasoning, or unclear process logic. - Structured Feedback & Quality Control - Provide clear written feedback explaining clinical, operational, administrative, pharmacy, compliance, or revenue cycle reasoning. - Follow detailed task instructions, quality criteria, and project-specific workflow standards accurately. - Review discrete healthcare workflow deliverables and identify areas for improvement. - Collaborate through asynchronous project workflows to improve healthcare process representations and AI-assisted outputs. Qualifications - Significant professional experience in healthcare, clinical practice, nursing, healthcare administration, compliance, pharmacy, medical records, health economics, revenue cycle, billing, reimbursement, or related healthcare operations. - Strong ability to clearly articulate clinical, administrative, regulatory, or operational reasoning. - Experience translating real-world healthcare decisions into structured workflows, documentation, training materials, or quality review outputs. - Strong attention to detail and ability to identify safety risks, process gaps, documentation issues, or reasoning errors. - Comfort reviewing AI-generated healthcare content and applying detailed evaluation criteria. - Excellent written communication skills. - Ability to work independently in a remote, asynchronous, project-based environment. - Current or recent healthcare domain expertise aligned with one or more project workstreams. Requirements - Physicians may have an MD or DO, active license, board certification, and experience in primary care, specialty practice, clinical quality, EHR workflows, or healthcare decision-making. - Nursing professionals may have an active RN license, clinical or nursing leadership experience, specialty certification, care coordination, quality improvement, or healthcare operations background. - Healthcare administrators may have hospital, health system, clinic operations, reimbursement, compliance, value-based care, or leadership experience; MHA or similar training may be relevant. - Health information and medical records professionals may have RHIA, RHIT, ICD-10, EHR documentation, coding, documentation accuracy, or compliance audit experience. - Healthcare compliance and regulatory professionals may have experience with HIPAA, state licensing, accreditation, fraud and abuse compliance, or healthcare legal and regulatory frameworks. - Health economics and data analysis professionals may have experience with claims data, outcomes research, health IT, EHR analysis, claims databases, or healthcare analytics. - Pharmacy professionals may have a PharmD, active license, clinical or hospital pharmacy experience, medication therapy management, or drug interaction expertise. - Medical billing and revenue cycle professionals may have experience in billing operations, reimbursement, coding, claims, denials, or healthcare financial workflows. Nice to Have - 7+ years of experience in a relevant healthcare domain, or equivalent senior-level expertise depending on role type. - Experience with clinical pathways, quality metrics, EHR workflows, documentation standards, care coordination, utilization management, or value-based care. - Familiarity with HIPAA, accreditation standards, payer requirements, healthcare compliance frameworks, or healthcare regulatory review. - Certifications such as RHIA, RHIT, CCS, CPC, specialty nursing certifications, compliance credentials, pharmacy credentials, or revenue cycle certifications. - Experience creating SOPs, workflow documentation, training materials, audit findings, clinical education content, or structured healthcare process maps. - Experience completing sample tasks, rubric-based reviews, clinical documentation reviews, healthcare quality audits, or structured AI evaluation work. Why This Opportunity - Apply healthcare domain expertise to structured remote project work. - Contribute to high-quality AI-assisted healthcare workflow training and process evaluation. - Use clinical, administrative, compliance, pharmacy, health information, revenue cycle, or healthcare analytics judgment in a focused review environment. - Work on discrete healthcare workflow deliverables aligned with professional credentials and subject-matter expertise. - Remote structure with competitive compensation. Contract Details - Independent contractor role. - Fully remote with flexible scheduling. - Eligible professionals may be based in approved project locations, including Australia, Canada, the United Kingdom, and the United States, depending on project needs. - Work may be structured around discrete healthcare workflow deliverables or task-based assignments. - Part-time project-based commitment depending on availability, onboarding status, credentials, and project needs. - Competitive rates of up to $90 per hour depending on healthcare expertise, credentials, task quality, and project scope. - Screening may include resume or experience summary review, a short practice-area form, license or certification details where relevant, and a brief sample task. - Weekly payments via Stripe or Wise. - Projects may be extended, shortened, or adjusted depending on scope and performance. - Work will not involve access to confidential or proprietary information from any employer, client, vendor, or institution. About the Platform This opportunity is available through 24-MAG LLC. We connect experienced professionals with remote consulting opportunities across technical, evaluation, and project-based workstreams. By submitting this application, you acknowledge that your information may be processed by 24-MAG LLC for recruitment and opportunity matching in accordance with our Privacy Policy: https://www.24-mag.com/privacy-policy .
• Lead UBC project teams to deliver project milestones • Serve as the primary contact with the sponsor for all study related items • Oversee all aspects of project conduct, from study start-up through close-out • Execute operational aspects of assigned project activities • Assist in the development and design of protocols, CRFs, regulatory documents, project master file, and other project related deliverables • Ensure operational plans are developed consistent with project needs • Monitor project progress as compared to established plans and ensure compliance • Facilitate and plan investigator meetings • Recruit qualified investigators and assist in budget negotiations • Supervise APM/PMs and other team members to ensure project deliverables • Provide reports to the Sponsor on project progress • Maintain project documentation to be "audit ready"
BridgeBio Pharma is on a mission quickly and safely discover, develop, and deliver breakthrough medicines to patients with genetic diseases. To reach this goal, the company strives
Role Description The Clinical Trial Educator (CTE) reports to and works with the Exec/Sr./Director of Clinical Operations to provide a high-touch service to clinical study investigators and site research teams. This is accomplished through ongoing engagement for Eidos clinical trials with a purpose of proactively increasing study and data quality and proactively identifying and mitigating operational risks. The CTE is a critical role in keeping the study “top of mind” with our sites, guiding sites through complex study procedures, and is one of the key Sponsor points-of-contact for the Principal Investigators and all clinical site research staff team members. The CTE will continually look for opportunities to optimize the execution of the study(ies) in such a way as to ensure robust protocol adherence, GCP compliance and high-quality data collection in a timely manner. Responsibilities - Maintains clinical knowledge of the therapeutic area landscape including current treatment strategies, current and pending competitors, and new therapeutic developments. - Establishes and maintains collaborative relationships with key therapeutic area experts, investigators, and institutions, serving as a key Eidos contact for investigative sites. - Collaborates with clinical development and operational teams, as well external service providers as appropriate to coordinate and optimize educational and research support for sites/investigators participating in BBIO's clinical trials, creating and contributing to study documents as needed. - Provides ongoing evaluation of enrollment status by site to ensure they are meeting expected goals, as well as patient compliance and study completion. - Provides white glove experience and oversight of key study procedures during identified needs, such as screening, working with sites to ensure understanding and guide through the process as needed. - Identifies and communicates key clinical and investigational study issues and insights from investigative sites to appropriate departments to help shape program level strategies, and assists study centers and CROs with “trouble-shooting” throughout the study, including site start-up activities, support during study maintenance, and supporting study endpoints through specifically training procedures. - As requested, participates in medical education for healthcare professionals through presentations and investigator interactions such as investigator meetings and other appropriate venues to enhance product and disease state knowledge. - May assist in CRA monitoring oversight as needed. Qualifications - BA/BS or MA/MS in biological or medical field required or relevant experience; advanced degree or clinical background preferred. - Minimum of 10 years of relevant clinical experience in the pharmaceutical, biotech and/or CRO industries, with at least 5 years of experience in a similar role. - Strong interpersonal skills and excellent relationship-building skills. - In-depth knowledge of FDA regulations, GCP, GCDMP and ICH guidelines required. - Clear scientific curiosity and interest in drug development. - Strong verbal and written communication skills. - Passion for helping patients. - Identifies and applies advanced practices, technical principles, theories and/or concepts, and contributes to the development of new principles and concepts; has a comprehensive understanding of current approaches in industry and ability to incorporate them into Eidos’ programs. Requirements - Travel- 20% Benefits - Market-leading compensation. - 401(k) with employer match. - Employee Stock Purchase Program (ESPP). - Pre-tax commuter benefits (transit and parking). - Referral bonus for hired candidates. - Subsidized lunch and parking on in-office days. - 100% employer-paid medical, dental, and vision premiums for you and your dependents. - Health Savings Account (HSA) with annual employer contributions, plus Flexible Spending Accounts (FSA). - Fertility & family-forming benefits. - Expanded mental health support (therapy and coaching resources). - Hybrid work model with flexibility. - Flexible, “take-what-you-need” paid time off and company-paid holidays. - Comprehensive paid medical and parental leave to care for yourself and your family. - People are part of our growth and success story - from discovery to active drug trials and FDA pipelines, there are endless opportunities for skill development and internal mobility. - We provide career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, & BetterUp Coaching. - We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities.
Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.
Role Description Otsuka is seeking a Senior Manager, Global Clinical Development (GCD) - Metabolic Dietitian based remotely or in our Princeton, NJ or Rockville, MD offices, who will be responsible for providing dietary and metabolic expertise to support the design, execution, and oversight of clinical research programs under Good Clinical Practice (GCP). The incumbent will support the clinical development of therapies for Rare Diseases and Inherited Metabolic Disorders (e.g., PKU, UCD, MSUD) across multiple stages of development. - Consults with investigators, site dietitians, patients, and cross‑functional partners and applies insights to optimize study design, dietary endpoints, and protocol implementation. - Serves as a metabolic nutrition subject‑matter expert, supporting clinical development, medical affairs, regulatory, and other project team members. - Provides input into protocol design and study strategy, particularly for trials involving dietary interventions, normalization, and metabolic endpoints. - Oversees dietary data collection and quality, ensuring consistency, accuracy, and adherence to protocol‑specified dietary guidelines. - Supports site selection, training, and ongoing engagement of site dietitians and investigators. - Provides guidance on dietary variability and its impact on clinical endpoints, ensuring appropriate interpretation of study results. - Collaborates cross‑functionally with Clinical Operations, Biostatistics, Regulatory, and Medical Affairs to support study execution and data interpretation. - Contributes to analysis and communication of clinical trial results, integrating dietary context into scientific outputs. - Supports post‑approval readiness and real‑world implementation, ensuring alignment between clinical data and dietary practice. - Engages with external stakeholders, including metabolic dietitian networks, professional societies (e.g., GMDI), and key opinion leaders. - Supports vendor and CRO interactions related to dietary components of clinical trials. Qualifications - Registered Dietitian (RD/RDN) with expertise in metabolic or inherited metabolic disorders. - ≥ 5 years of experience in clinical practice, clinical research, or pharmaceutical/biotech industry. - Demonstrated experience in dietary management of PKU and/or other IEMs. - Experience supporting or participating in clinical research or clinical trials. - Strong understanding of dietary assessment methods and metabolic clinical endpoints. - Ability to communicate effectively in meetings and via written and oral presentations. - Experience working in cross‑functional, matrixed environments. Requirements - Experience in pharmaceutical or biotech clinical development (preferred). - Familiarity with GCP and regulatory requirements (preferred). - Experience with protocol development, site training, and/or real‑world evidence generation (preferred). - Established network within the metabolic dietitian community (preferred). - Experience engaging with professional organizations (e.g., GMDI) (preferred). Benefits - Comprehensive medical, dental, vision, prescription drug coverage. - Company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance. - Tuition reimbursement and student loan assistance. - A generous 401(k) match. - Flexible time off, paid holidays, and paid leave programs. - Other company provided benefits.
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
Role Description We are seeking a Global Clinical Operations Leader/Clinical Trial Manager to join our team in a remote position. As a Global Clinical Operations Leader/ Clinical Trial Manager, you will lead the clinical operations strategy and execution of global clinical trials. This role has direct accountability for delivering studies on time within budget and to the highest quality standards while ensuring patient safety and regulatory compliance. You will serve as the primary clinical liaison to project leadership and sponsor teams coordinating cross functional contributors across regions and time zones. This is a highly visible leadership role suited for individuals who thrive in complex global environments and are comfortable making decisions in ambiguous situations. Success requires strong ownership, the ability to lead without close supervision and a history of delivering clinical trials within a CRO environment. Key Responsibilities - Lead global clinical operations strategy and execution for assigned clinical trials. - Drive study startup including site selection, monitoring strategy, and operational planning. - Coordinate cross functional teams across geographies ensuring alignment on timelines, quality and deliverables. - Monitor study progress including recruitment, retention, data quality and timelines and take corrective action when needed. - Identify risks early and implement mitigation and contingency plans. - Provide leadership direction and performance feedback to project team members. - Function as primary point of contact for sponsors on clinical operations topics. - Ensure compliance with ICH GCP regulatory requirements and internal processes. - Oversee maintenance and quality of study documentation and central files. - Support audits, inspections and study closeout activities including database lock and archiving. - Provide strategic oversight of the integrated data delivery (IDD) framework and champion a proactive data-quality culture. Qualifications - Strong leadership, decision making and problem-solving skills. - Demonstrated ability to lead global teams across cultures and time zones. - Ability to prioritize competing demands and remain accountable for outcomes. - A proactive mindset with strong ownership and sense of urgency. - Excellent communication and stakeholder management skills. - Comfort working in a fast-paced performance driven environment. Requirements - Degree in life sciences, nursing, or equivalent clinical research experience. - Minimum of 5 years of experience leading clinical operations within a CRO environment. - Proven experience in roles such as Clinical Trial Manager, Clinical Project Manager or Clinical Operations Leader. - Experience leading complex global or multi-region studies. - Strong knowledge of ICH GCP regulatory requirements and clinical trial processes. - Experience coordinating cross functional teams and managing study timelines, budgets and quality. - Proficiency with clinical systems and standard tools such as CTMS, EDC, and eTMF. Preferred Qualifications - Prior monitoring experience or strong site engagement background. - Experience contributing to process improvements or operational excellence initiatives. - Familiarity with multiple therapeutic areas or late phase studies with priority given to those with Metabolic, Obesity, MASH, Ophthalmology and Dermatology / Immunology. Benefits The potential base pay range for this role is competitive and aligned to experience level, location and demonstrated expertise. Additional incentives may be available based on performance and role scope. This role is designed for experienced clinical leaders who are ready to take full ownership of global trial delivery. If you are looking for a position with clear accountability, high expectations and meaningful impact on patient outcomes this is the right opportunity. EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
Role Description The Senior Project Manager (SPM) is responsible for leading and delivering complex clinical business process outsourcing (BPO) projects across multiple clients and therapeutic areas. This role ensures projects are executed on time, within scope, and within budget while maintaining high-quality standards and regulatory compliance. The SPM serves as the primary point of contact for clients and internal stakeholders, driving operational excellence and client satisfaction. - Lead end-to-end project management for clinical BPO programs including planning, execution, monitoring, and closure. - Develop and manage project plans, timelines, budgets, and resource allocation. - Serve as the primary client liaison, ensuring transparent communication and proactive issue resolution. - Oversee cross-functional teams including clinical operations, data management, pharmacovigilance, and regulatory support. - Ensure compliance with GxP, FDA, ICH, and other applicable regulatory requirements. - Identify risks and implement mitigation strategies to ensure project success. - Track project performance metrics and provide regular status reports to stakeholders. - Drive continuous improvement initiatives and process optimization within the BPO environment. - Support business development activities including proposals, bids, and client presentations. - Mentor and coach junior project managers and team members. Qualifications - Bachelor’s degree in Life Sciences, Healthcare, Business, or related field; advanced degree preferred. - 8–12+ years of experience in clinical research, outsourcing, or healthcare BPO environment. - 5+ years of project management experience managing complex, multi-functional projects. - Strong knowledge of clinical trial processes and regulatory requirements. - Proven experience managing global or multi-regional projects. Requirements - Project Management Professional (PMP) or equivalent (e.g., PRINCE2 Practitioner). - Good Clinical Practice (GCP) Certification. - ICH-GCP training certification (current and up to date). - Clinical research compliance training (e.g., FDA, EMA regulatory training). - Lean Six Sigma Green Belt or higher (preferred in BPO operational environments). Skills & Competencies - Exceptional leadership and stakeholder management skills. - Strong communication and client-facing abilities. - Financial acumen including budgeting and forecasting. - Risk management and problem-solving expertise. - Ability to manage multiple priorities in a fast-paced environment. - Proficiency in project management tools (e.g., MS Project, Smartsheet). Work Environment This role operates in a dynamic, client-driven clinical BPO environment, requiring collaboration across global teams and flexibility to accommodate different time zones. Reporting Structure Reports to: Senior Vice President of Clinical Operations Location Work@Home USA, United States of America
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