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Lightship logo
Lightship

Redefining trials. Providing hope for all.

Clinical Project Manager

Clinical OperationsClinical OperationsOtherRemoteSeniorTeam 51-200H1B SponsorCompany SiteLinkedIn

Location

United States

Posted

104 days ago

Salary

$110K - $135K / year

Seniority

Senior

Bachelor Degree5 yrs expEnglishGCP

Job Description

Clinical Project Manager

Lightship

• Leading cross-functional teams and third parties/vendors to ensure successful project delivery. Overseeing clinical research conduct, including study start-up, enrollment, execution, and close-out • Acting as liaison with the client and managing client contractual, organizational and relationship needs/expectations, related to operational delivery of assigned projects • Managing project contractual deliverables and modifications, and preparing and delivering study-related updates, dashboards and reports to study teams, senior management, and sponsors / vendors / partners, including but not limited to recruitment, screening, and enrollment reports • Ensuring project management systems are updated weekly to reflect accurate project status • Serving as a point of escalation for project team members • Ensuring project resources are appropriately assigned in project management system and updating forecasted project hours per resource to accurately reflect project needs • Participating in revenue forecasting and review of project actual unit/hours efficiency against budget • Identifying and managing scope changes with the client with support of the project Director as necessary • Ensuring Director and Client Partner are kept informed of project progress through the provision of appropriate and regular updates • Developing operational plans (including operational guidelines, manuals and project plans as needed) • Overseeing all operational aspects of assigned clinical studies in accordance with local regulations, ICH GCP guidelines, SOPs (Standard Operating Procedures), and project specific plans

Job Requirements

  • Undergraduate, health-related degree OR an equivalent combination of education, training, and experience sufficient to successfully perform the key responsibilities of the job
  • 5+ years of relevant clinical research experience and solid knowledge and understanding of clinical project / trial management
  • Experience working in a CRO, Site, SMO or Sponsor preferred
  • Highly developed spoken and written communication skills, excellent presentation skills
  • Knowledge/expertise in the applicable regulations/guidelines for, and the conduct of clinical trials (virtual/DCT trial experience preferred)
  • Experience using a Clinical Trial Management System (CTMS) platform or equivalent
  • Strong interpersonal, collaboration and time management skills
  • Ability to establish and maintain effective working relationships with project team members, other cross functional stakeholders, and clients
  • Proactive, innovative problem solver with good analytical and critical thinking skills to appropriately anticipate and manage risks before they turn into issues, as well as to identify the root cause of issues and implement solutions, escalating to management for support appropriately
  • Ability to influence stakeholders at all levels with confidence and adapt style to deliver messaging. Issues may be complex, audience perspectives may be divergent, and information may be non-routine in nature
  • Able to work in a fast-paced, evolving environment
  • Ability to embrace and manage change, be agile and adaptable
  • Able to work independently with minimal guidance in an unstructured environment

Benefits

  • Top notch healthcare (medical, dental, and vision) for you and your family.
  • A 100% 401(k) company match for up to 4% of eligible contributions with an immediate vesting.
  • Company provided laptop, your choice of a PC or a Mac
  • Monthly stipend for internet and phone expenses
  • Short & long-term disability
  • Life insurance and More!

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Penn State University logo

Sexual Assault Nurse Examiner Clinical Coordinator

Penn State University

Penn State is an equal opportunity employer and is committed to providing employment opportunities to all qualified applicants without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If you are unable to use our online application process due to an impairment or disability, please contact 814-865-1473. Penn State is committed to and accountable for advancing equity, respect, and belonging. We embrace individual uniqueness, as well as a culture of belonging that supports equity initiatives, leverages the educational and institutional benefits of inclusion in society, and provides opportunities for engagement intended to help all members of the community thrive. We value belonging as a core strength and an essential element of the university’s teaching, research, and service mission.

OtherRemoteTeam 1,001-5,000

APPLICATION INSTRUCTIONS: - CURRENT PENN STATE EMPLOYEE (faculty, staff, technical service, or student), please login to Workday to complete the internal application process. Please do not apply here, apply internally through Workday. - CURRENT PENN STATE STUDENT (not employed previously at the university) and seeking employment with Penn State, please login to Workday to complete the student application process. Please do not apply here, apply internally through Workday. - If you are NOT a current employee or student, please click “Apply” and complete the application process for external applicants. Approval of remote and hybrid work is not guaranteed regardless of work location. For additional information on remote work at Penn State, see Notice to Out of State Applicants. This position is funded for 1 year(s); continuation past 1 year(s) will be based on university need, performance, and/or availability of funding.​ POSITION SPECIFICS​ The Sexual Assault Forensic Examination Telehealth (SAFE-T) System, housed within Penn State's Ross and Carol Nese College of Nursing, is seeking a Sexual Assault Nurse Examiner (SANE) Clinical Coordinator – a full-time leadership role. About SAFE-T System SAFE-T System is a successful telehealth sexual assault nurse examiner (SANE) or "teleSANE" program aimed at increasing access to high-quality sexual assault forensic care through innovative telehealth technology. Our program delivers live expert SANE consultation to partnered hospitals. We're breaking down barriers to ensure survivors receive expert, compassionate care wherever they are. The Opportunity Join our mission-driven team as a Clinical Coordinator and help bring expert sexual assault forensic care to communities nationwide. This forensic nurse/SANE leadership position combines expertise in SANE/SAFE care with administrative and leadership duties. This nursing clinical leadership position will co-lead a team of highly experienced, board-certified adult and pediatric SANEs (SANE-A, SANE-P) in the delivery of live quality assurance, mentorship, and peer review during forensic examinations via telehealth. This position will join other SAFE-T Clinical Coordinators in collaboration with the entire SAFE-T System team, including the Program Director, Assistant Director, Research Team, and IT Team to implement, support, and grow SAFE-T's telehealth program. As a Clinical Coordinator, you will support all facets of SAFE-T’s clinical operations: program implementation, telehealth consultation, teleSANE team management, development and delivery of clinical training, peer review, community engagement, and partner site success. You'll work alongside other clinical coordinators as part of a dynamic clinical operations team to ensure all program functions are covered Key Responsibilities of the Clinical Coordinator: Clinical Leadership - Lead and manage the teleSANE team, providing oversight, mentorship, and performance reviews of telehealth forensic exams. - Recruit, hire, and train new teleSANEs; develop policies, procedures, and training materials. - Develop and deliver trainings, including in-person sessions at Penn State’s University Park campus. - Foster a positive and supportive environment for SANEs. - Assist SANEs at partnered sites with court testimony preparation when subpoenaed. - Provide project management; track project efforts and status. - Lead monthly teleSANE team meetings (typically held in the evening). - Serve as faculty for SAFE-T trainings including Journal Club, Photo Review, and Clinical Skills Lab. Program Development & Growth - Support larger program goals (e.g., grant applications, progress reporting, and data collection) - Contribute to outreach to new sites, SAFE-T strategic initiatives, and program sustainability. Clinical Program Delivery & Administration - Site Success: support partner hospital site SANE programs and help them thrive. - Ensure seamless clinical service delivery in collaboration with co-coordinators. - Ensure all teleSANE shifts are covered and with no gaps in schedule. - Support SAFE-T System implementation at new partner hospitals. - Develop working relationships with interdisciplinary partners and hospital stakeholders. - Identify gaps in sexual assault care and help sites set and achieve goals. - Contribute to SAFE-T clinical goal setting, planning, and innovation. - Conduct annual hospital review presentations to share data and progress over past year. - Support fiscal decisions and budget management activities. Quality Improvement & Innovation - Evaluate telehealth consultations for quality. - Provide feedback and mentorship to teleSANEs. - Hold teleSANEs accountable for meeting desired level of quality in telehealth consultations. - Monitor and identify latest industry best practices, updates, and trends. - Perform after-action reviews, continuous quality improvement, and program evaluation; recommend system enhancements. - Contribute to research and evidence-based practice initiatives. - Test new technologies and participate in technology improvement activities. - Actively contribute in team meetings, bringing ideas forward. Clinical Coordinators share in teleSANE call coverage during the Monday thru Friday, 5 a.m. to 5 p.m. Eastern shift. This is part of regularly assigned duties. Clinical Coordinators are hired as part-time SAFE-T teleSANEs (and compensated accordingly) for additional call coverage. - You will be expected to be on-call for occasional overnight shifts (5 p.m. to 5 a.m. ET) and/or 48-hour weekend shifts (5 a.m. Saturday to 5 a.m. Monday) as necessary. - How often you take overnight and/or weekend shifts depends on whether there are gaps in the call schedule and if there are new teleSANEs needing call observation. Travel Travel is required, typically 6 to 8 times annually, with trips lasting 4 to 5 days on average. What We're Looking For This is a nursing position. Three years of work experience as a sexual assault nurse examiner (SANE), seeing at least 30 cases annually, is required. Current International Association of Forensic Nurses (IAFN) Sexual Assault Nurse Examiner–Adult/Adolescent (SANE‑A) and/or Sexual Assault Nurse Examiner–Pediatric (SANE‑P) certification is strongly preferred. Leadership experience in healthcare settings and experience collaborating with healthcare administrators, emergency departments, and interdisciplinary teams will also be considered a plus. Essential Skills - Communication: Exceptional verbal and written communication skills - Leadership: Ability to lead teams and manage complex projects - Organization: Excellent organizational skills; ability to prioritize and meet deadlines - Adaptability: Thrives in a fast-paced, innovative environment - Independence: Ability to hold oneself accountable; self-motivated and can drive work forward with minimal supervision - Diplomacy: Advanced interpersonal skills for challenging situations, ability to build rapport and develop key partnerships - Technology: Proficiency with Microsoft Office Suite MINIMUM EDUCATION, WORK EXPERIENCE & REQUIRED CERTIFICATIONS Bachelor's Degree 8+ years of relevant experience, includes 3+ years of supervisory experience Required Certifications: Registered Nurse - Pennsylvania State Board of Nursing Candidates must possess an active, unrestricted Registered Nurse license prior to hire. Upon hire, candidates will be required to obtain active nursing licensure in all states where SAFE-T is partnered (currently Idaho and Pennsylvania). Compact nursing licensure may substitute for individual state licensure wherever states allow. The Ross and Carol Nese College of Nursing is supportive of flexible work arrangements, such as remote or hybrid work opportunities, when aligned with the ability to meet the needs of the unit and the essential duties of the position. Questions related to flexible work and/or remote arrangements should be directed to the hiring manager during the interview process. Ready to join our innovative team? Apply today and help us transform sexual assault care through technology and compassion. BACKGROUND CHECKS/CLEARANCES This position requires the following clearances in addition to applicable background checks: PA State Police Criminal Background Check, PA Child Abuse History Clearance Form, and Federal (FBI) Fingerprint Criminal Background Check. This position requires that you operate a motor vehicle as a part of your job duties. A valid driver’s license and successful completion of a motor vehicle records check will be required in addition to standard background checks. Penn State does not sponsor or take over sponsorship of a staff employment Visa. Applicants must be authorized to work in the U.S. SALARY & BENEFITS The salary range for this position, including all possible grades, is $76,700.00 - $115,100.00. Salary Structure - Information on Penn State's salary structure Penn State provides a competitive benefits package for full-time employees designed to support both personal and professional well-being. In addition to comprehensive medical, dental, and vision coverage, employees enjoy robust retirement plans and substantial paid time off which includes holidays, vacation and sick time. One of the standout benefits is the generous 75% tuition discount, available to employees as well as eligible spouses and children. For more detailed information, please visit our Benefits Page. CAMPUS SECURITY CRIME STATISTICS Pursuant to the Jeanne Clery Disclosure of Campus Security Policy and Campus Crime Statistics Act and the Pennsylvania Act of 1988, Penn State publishes a combined Annual Security and Annual Fire Safety Report (ASR). The ASR includes crime statistics and institutional policies concerning campus security, such as those concerning alcohol and drug use, crime prevention, the reporting of crimes, sexual assault, and other matters. The ASR is available for review here. EEO IS THE LAW Penn State is an equal opportunity employer and is committed to providing employment opportunities to all qualified applicants without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If you are unable to use our online application process due to an impairment or disability, please contact 814-865-1473. Penn State is committed to and accountable for advancing equity, respect, and belonging. We embrace individual uniqueness, as well as a culture of belonging that supports equity initiatives, leverages the educational and institutional benefits of inclusion in society, and provides opportunities for engagement intended to help all members of the community thrive. We value belonging as a core strength and an essential element of the university’s teaching, research, and service mission. Federal Contractors Labor Law Poster PA State Labor Law Poster Penn State Policies Copyright Information Hotlines

United States
$76.7K - $115K / year
Job Closed
ClinChoice logo

Clinical Project Manager II

ClinChoice

The Standard of Excellence

OtherRemoteTeam 1,001-5,000Since 1998H1B Sponsor

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds…. ClinChoice is seeking a Clinical Project Manager II to partner with one of our sponsors in leading a clinical sleep study. This role requires demonstrated experience managing medical device clinical trials, with a strong preference for respiratory study experience. The ideal candidate will bring expertise in overseeing study execution, ensuring regulatory compliance, and driving cross-functional collaboration to deliver high-quality results on time and within scope. This is a remote W-2 position on a one-year contract. ClinChoice is a global full-service CRO with a strong focus on quality and professional development. As a client-facing role, we are looking for confident candidates with the ability to work independently while establishing a high-trust environment with their client counterparts. Main Job Tasks and Responsibilities: - Manages the delivery of study requirements to the protocol and regulations such as GCP and ISO 14155, the site needs and the required timelines set for the project. - Apply principles, concepts and techniques for effective and proactive project management of a clinical study. - Balances resource constraints (i.e. time, money, people, and equipment) against deliverables. - Develop clinical study budget and may assist in quarterly departmental budget reviews. - Seeks input from higher-level clinical experts or program management as issues warrant. - Leverage experience and work with collaborative team members to recommend and implement methods for improving processes and addressing issues within the clinical operations department. - Implement and maintain risk-based monitoring processes to drive efficient and effective study management. - Oversee and review data and/or monitoring reports for protocol violations and serious protocol deviations, and proactively address violations/deviations, to assure protocol and GCP compliance. - Train and mentor more junior staff on monitoring, internal procedures, and query resolution to assure alignment and GCP compliance. Education, Experience and Skills: - Bachelor's or advanced degree in a relevant scientific discipline. - 3-5 years of medical device clinical project management experience. - Experience with sleep and respiratory studies are required. - In-depth knowledge of ICH-GCP, EMEA guidelines and other relevant regulations and guidelines. - Proven ability to manage clinical studies within timelines and budgets while maintaining high quality standards and patient safety. - Ability to proactively develop risk management and mitigation plans in country and resolve issues locally. - Effective and efficient time management, organizational and interpersonal skills, conflict management and problem-solving skills. - High sense of accountability and urgency to prioritize deliverables. - Strong communication skills and negotiation skills as well as excellent influencing and training/mentoring, both written and verbal. - Ability to focus on multiple deliverables and protocols simultaneously is essential. - Positive mindset, growth mindset, capable of working independently and being self-driven. - Able to directly influence Clinical Operations staff. The Application Process Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful. Who will you be working for? About ClinChoice ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical devices, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. Our Company Ethos Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset, and they are the fulcrum around which all ClinChoice activities are built, and close management and training is the core instrument to develop and maintain highly-qualified personnel. Continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates. ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it. Key Words: Clinical Study Management, Clinical Project Management, Clinical Operations, Study Delivery, Protocol Compliance, GCP (Good Clinical Practice), ISO 14155, Risk-Based Monitoring (RBM), Study Timelines, Resource Management, Budget Development, Budget Oversight, Clinical Study Budgeting, Protocol Deviations, Serious Adverse Events (SAE) Oversight, Regulatory Compliance, Audit Readiness, Monitoring Reports Review, Data Review & Oversight, Quality Assurance, Inspection Preparedness, Cross-Functional Collaboration, Site Management, Monitoring Oversight, Query Resolution, Risk Management, Vendor Management, Study Start-Up & Close-Out, Clinical Trial Lifecycle Management, Medical Devices, Respiratory, Sleep Studies #LI-VH #LI-Remote #Project Manager # Contract

United States
Job Closed
Meta Resources Group logo

Clinical Project Manager

Meta Resources Group

Global IT consulting and advisory services.

OtherRemoteTeam 51-200H1B No Sponsor

Our Client, a global pharmaceutical company, is looking for a Clinical Project Manager who will own the full lifecycle of a sample distribution program, ensuring that all phases from design through delivery are executed on schedule and in compliance with regulatory requirements. This includes developing and maintaining SOPs and PDMA compliance documentation, coordinating the technical implementation of sample-tracking tools in the CRM system, and training the field sales team on proper sampling procedures. The candidate will act as the primary liaison between the client, salesforce presenting project updates and reports. This is a remote, contractual position, that goes until the end of September 2026, with the likelihood of extension. Candidate's applying for this role must be located in the EST or CST time zones of the USA. Key Responsibilities - Oversee the entire physician sampling initiative from defining processes and launching new sample offerings to ongoing distribution and reconciliation. This involves managing logistics and inventory, tracking sample usage, and closing the loop on returned or expired samples. - Oversee coordination between clinical operations, medical affairs, and commercial teams to ensure that sampling programs align with clinical guidelines, therapeutic protocols, and product lifecycle strategies. - Collaborate with clinical data management and medical affairs teams to ensure that any clinical data or insights related to physician sampling programs are properly captured, documented, and aligned with regulatory requirements. - Work with clinical stakeholders and regulatory teams to support audit readiness, ensuring all documentation and sampling processes meet clinical trial support standards and healthcare compliance expectations. - Support cross-functional initiatives between clinical operations, regulatory affairs, and commercial teams when sampling activities relate to product launches, clinical education programs, or therapeutic area expansion. - Contribute to clinical process improvement initiatives, ensuring that digital tools, CRM workflows, and operational processes support both commercial sampling activities and broader clinical engagement strategies. - Draft, update and enforce SOPs and compliance materials (PDMA submission packages, FDA/21 CFR compliance documents, etc.) for all sampling activities. Ensure the program adheres to federal regulations and company policies. - Work closely with IT and technical teams to implement or upgrade the CRM’s sample-tracking module (e.g. Veeva or Salesforce). Validate system configuration, manage user acceptance testing, and ensure the CRM supports audit trails and reporting requirements. - Design and deliver training programs for the sales field team on sampling SOPs and PDMA compliance. Develop training materials and metrics, spearheaded the development of training initiatives that improved compliance to ensure sales reps understand proper procedures and documentation. - Serve as the main point of contact for client teams and physician offices. - Track program performance and prepare regular reports (e.g., monthly/quarterly summaries of sample distribution, inventory levels, and compliance KPIs). Requirements - 4-5 years’ experience managing pharmaceutical or sales support programs. Demonstrated ability to run a full sample program “from end to end”, including inventory management and sample accounting. - Solid knowledge of FDA/PDMA regulations for drug samples. Proven skill in writing and maintaining SOPs and compliance documents for projects. - Hands-on experience with CRM platforms (e.g. Salesforce, Veeva). - Ability to coordinate with IT and vendors on system configuration and data integration. - Background in pharma or biotech environments, especially commercial operations (sales, marketing, compliance). - Experience working in pharmaceutical, biotech, or clinical research environments, with exposure to clinical operations, medical affairs, or regulatory processes. - Understanding of clinical governance frameworks such as GxP (GCP, GVP, or GMP) and their interaction with commercial and physician engagement programs. - Experience collaborating with clinical stakeholders, regulatory teams, or medical affairs to ensure compliance and operational alignment. - Familiarity with clinical documentation standards, audit preparation, and healthcare regulatory oversight. Preferred Qualifications - Experience with sample distribution software or electronic sample closets (e.g. Deploy, SampleIQ) and digital sampling strategies. - MBA or advanced degree in life sciences/pharmacy; PMP or Six Sigma/Lean certification. - Exposure to clinical systems integration, including collaboration between CRM platforms and clinical data systems. - Experience supporting clinical-commercial hybrid programs, such as physician education initiatives, product launch support, or clinical engagement tracking. - Background working in regulated healthcare environments where clinical, compliance, and commercial processes intersect.

United States
Job Closed
Marathon Health logo

Clinical Technology Trainer

Marathon Health

We are Marathon Health. We’re building better, together.

OtherRemoteTeam 1,001-5,000Since 2005H1B Sponsor

This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description As the Clinical Technology Trainer, the primary focus is to ensure Marathon providers and clinical teammates have the training and support they need to optimize their use of Marathon's electronic health record (EHR) and supporting clinical applications. - Conduct workflow analysis, application optimization, training, communications, and ongoing support. - Contribute to ensuring the effective and efficient use of clinical systems to achieve clinical goals, high quality outcomes, and maximize teammate satisfaction. Essential Duties & Responsibilities - Provides clinical IT system training and support for newly onboarding clinics and new hires. - Completes training, implementation, testing, and support of clinical applications including, but not limited to, eClinicalWorks, Salesforce, Rubicon, Up to Date, Dragon, and other office automation products used by providers and clinical staff. - Ensures clinical workflows, data management, and integration processes are implemented to support reliable, accurate, scalable, and timely reporting to all internal and external stakeholders. - Supports standardization and delivers a consistent approach relating to the implementation and training of new clinics and teammates. - Provides support for eClinicalWorks and clinical system upgrades and new implementations. - Supports and promotes systems standardization, utilization, and best practices in clinical information technology. - Promotes system security, patient confidentiality, and helps ensure compliance with applicable laws and regulations (i.e., HIPAA). - Assists in designing and delivering training and development programs based on both enterprise and individual needs. - Monitors and reviews the progress of clinical teammates, assesses training effectiveness, identifies improvement opportunities, and implements changes to the training program. - Trains and supports the development of “super users” of clinical information technology and related capabilities. - Represents Marathon to the medical community and clinic staff and serves as an advocate in promoting the use of information technology in the clinical setting. - Works in concert with the Vice President, Clinical Technology, and key stakeholders to gain feedback from the clinic teams. - Serves as an enterprise subject matter expert (SME) on EHR and other clinical support systems. - Successfully works and resolves Help Desk Tickets as required and as it relates to EHR and other clinical support systems as assigned. - Participates in special projects as needed and performs other duties as assigned. Qualifications - Bachelor’s degree plus a minimum of 3 years of training experience in a Health Care related field, preferably Electronic Health Records. - 2+ years of experience working with EHR systems and clinical technologies (eClinicalWorks experience preferred) or equivalent combination of education and experience. Desired Attributes - Skilled at providing high quality support to Marathon teammates with a high degree of customer service, technical expertise, timeliness, and professionalism. - Good working knowledge of healthcare, in particular physician practice and clinic workflows, IT systems, and facilities. - Working knowledge of privacy and security standards (e.g., HIPAA). - Proficient in Microsoft Products- Word, Excel, PowerPoint, and Visio, preferred. Pay Range $65,000 - $85,000/yr. The actual offer may vary dependent upon geographic location and the candidate’s years of experience and/or skill level.

United States
Job Closed