Senior Clinical Trial Manager
Location
United States + 1 moreAll locations: United States | Canada
Posted
1 day ago
Salary
0
Seniority
Lead
No structured requirement data.
Job Description
Senior Clinical Trial Manager
Parexel
Role Description The Senior Clinical Trials Manager (Sr. CTM) will be a member of the client’s Clinical Operations team. - Oversight of activities - Manage complex Phase 1, 2, 3, and 4 clinical trials as part of a global clinical operations team. - Demonstrate oversight of CROs and work in a quality framework that supports confirmatory trials. - Provide direction and leadership in CRO and vendor selection and management. - Knowledge of regulatory start up process and planning in support of study start up. - Managing and maintaining high performing clinical teams. - Coordination of global clinical trials. - Provide technical expertise for the development of clinical documents (protocols, monitoring plans, clinical trials report, investigator brochures, etc.) and trial conduct. - Coordinate closely with Clinical Development, Biostatistics, Data Management, Drug Safety, Legal, Finance, Product Development, Project Management and Regulatory to ensure operational excellence. - Be responsible for and manage clinical research activity of Clinical Operations team. - Estimate, track and critically analyze vendor financial spend on study. - Analyze and develop action plans to address issues with investigational sites, CRAs, and CROs. - Provide guidance, direction, and management to site monitoring activity. - Coordinate patient enrollment activities and mitigation planning. - Coordinate study supplies with regulatory and clinical supplies functions. - Negotiate contracts with vendors of clinical trial services. - Review Informed Consent Forms, CRFs, and study related materials. - Plan and participate in investigator meetings. - Assist and support data query process. - Assure regulatory compliance of investigational sites with client’s SOPs and FDA and ICH guidelines. - Ensures trial master file is current and maintained. - Collaborate in the management of external vendors and contract research organizations to ensure efficient execution of clinical trials. - Collaborate in the development of programming specifications. Qualifications - Excellent oral and written communication skills and strong organizational abilities. - Proficiency with MS Office (e.g. Word, Excel, PowerPoint, Outlook). - Demonstrated ability to work independently and in a team environment. - Ability to prioritize and manage multiple tasks simultaneously. - Responsibilities may require a work schedule that may include working outside of “normal” work hours, in order to meet business demands. Requirements - Proven experience of clinical trial management. - Proven management of people in a matrixed environment. - Experience in CNS and/or oncology is preferred. - Management of global clinical trials. - Demonstrated working knowledge of GCP, ICH guidelines and FDA regulations. - Travel required. Must be willing to travel 15-25%, including international travel. - Proven track record with relevant clinical trials experience, including strong performance as a CRA in the pharmaceutical industry (i.e. biotechnology, pharmaceutical, CRO, medical device). Education - BA/BS, nursing degree, or advanced degree. Degree in the life sciences preferred.
Related Guides
Related Categories
Related Job Pages
More Clinical Research Jobs
• In collaboration with other members of the clinical research site team works to ensure the execution of assigned studies. • Responsibilities may include but are not limited to: - Screening of patients for study enrollment; - Patient consents; - Patient follow-up visits; - Documenting in source clinic charts; - Entering data in EDC and answering queries; - Obtaining vital signs and ECGs; - May perform basic lab procedures per protocol, such as: blood specimen collection, centrifuge operation, storing and shipping of lab specimens, accountability of specimens and notification of courier for specimen pick-up; - Requesting and tracking medical record requests; - Updating and maintaining logs, chart filings; - Maintaining & ordering study specific supplies; - Scheduling subjects for study visits and conducts appointment reminders; - Building/updating source as needed; - Conducting monitoring visits and resolves issues as needed in a timely manner; - Ensuring study related reports and patient results are reviewed by investigator in a timely manner; - Filing SAE/Deviation reports to Sponsor and IRB as needed; - Documenting and reporting adverse events; - Reporting non-compliance to appropriate staff in a timely manner; - Maintaining positive and effective communication with clients and team members; - Always practicing ALCOAC principles with all documentation; - Complete all needed activities for study start-up, including completing required training, uploading / printing certificates to file in ISF, etc.; - Prepare and attend site initiation visits (SIV’s) and Investigator Meetings (IMs), as needed; - Handles all IRB functions for assigned studies independently, and/or with assigned regulatory team member, as needed; - Assist with training of new research assistants and coordinators; - Assist with scheduling and planning for visit capacity for assigned studies; - May set up, train and maintain all technology needed for studies; - May assist with study recruitment, patient enrollment, and tracking as needed; - May handle more complex study assignments and volumes; - May participate in community outreach/education events; - Maintaining confidentiality of patients, customers and company information, and; - Performing all other duties as requested or assigned.
Clinical Team Lead
Rho, Inc.Established in 1984, Rho is a full-service contract research - CRO organization that has developed an excellent reputation for providing an "unsurpassed degree
Role Description We are hiring a Clinical Team Lead! This is a permanent role to work remotely, with the expectation of occasional travel for site visits and client meetings. The Clinical Team Lead (CTL) is responsible for managing and maintaining ownership of the clinical operations aspects of assigned projects. This position is responsible for providing direction and training to CRAs assigned to the project. In addition, the CTL is responsible for the oversight of all operational aspects related to the planning and oversight of CRA and site performance. The CTL is responsible for ensuring that sites and CRAs operate in compliance with study protocols, ICH/GCP guidelines, and Federal Regulations. - Manages the end-to-end clinical execution of projects up to moderate complexity and scope and/or supports a senior-level CTL on more complex or larger scope projects, ensuring adherence to protocols, timelines, and regulatory requirements. - Oversees recruitment, study metrics monitoring, and documentation activities. With guidance, identifies issues and contributes to implementing solutions. - Ensure sites comply with Good Clinical Practice (GCP) and applicable regulations. - Collaborates with cross-functional teams (e.g., data management, regulatory, safety) to facilitate study deliverables. - Develops and manages clinical operation timelines, metrics, resourcing, budget and activities of projects up to moderate complexity and scope. May also support senior CTLs on more complex or larger scope projects. - Identifies potential risks and escalates to appropriate stakeholders, supporting collaboration and leading implementation of appropriate corrective actions and mitigation strategies. - Manages tracking and reconciliation of clinical budgets related to clinical operation activities such as monitoring visit and CRA allocation. Identifies potential budget variances and escalates to appropriate stakeholders to ensure timely corrective actions are taken and cost-effectiveness is maintained. - May assist with RFP strategic planning, budget development, and capabilities/response narratives. - Performs monthly assessment of CRA resourcing projections based on study parameters (e.g., active sites, projected Days On Site, upcoming milestones, etc.). Works with CRA Line Management to proactively confirm resourcing needs. - Serves as the lead clinical liaison among Clients, site staff, and internal teams on projects up to moderate complexity. - Leads internal and external meetings. - Manages routine Client communications and helps manage client expectations. - Communicates and works effectively with site staff, as needed, serving as an escalation point for CRAs as issues arise. - Leads CRAs and IHCRAs, including project training and onboarding. - Creates and conducts training sessions including investigator meetings, conferences, and team training. - Provides constructive performance feedback on CRAs/IHCRAs to line managers and project leads. - May participate in Bid Defense Meetings to present clinical operation and monitoring strategy. - Participates in upfront Protocol Deviation planning and identification, in support of finalization and maintenance of Protocol Deviation Plan and related activities. - Manages protocol deviation review and reconciliation throughout the study, ensuring timely documentation and resolution in collaboration with cross-functional teams and Client for review and approval on projects of up to moderate complexity. - Supports the identification and continuous assessment of clinical risks throughout the study and contributes to the development and implementation of risk mitigations on projects of up to moderate complexity. - Provides skilled review and development of study protocols and study-related documents and materials (e.g., clinical monitoring plan, protocol deviation plan, case report forms). - Oversees and performs on-site Quality Compliance Visits to review data across CRAs using a targeted, adaptive and/or risk-based approach focused on critical and safety related data points. Identifies trends and potential quality issues, escalating as appropriate. Collaborates with CRAs and study teams to implement corrective and preventive actions. Qualifications - Bachelor's Degree, preferably in a life science, nursing, pharmacy or related field. - 5 years of clinical research experience within the CRO, pharmaceutical, or biotechnology industry. - At least 2 years of experience working as a clinical team lead preferred. - At least 2 years of on-site monitoring experience. - Proven leadership capabilities with experience in leading teams within a CRO or pharmaceutical setting. - Strong knowledge of GCP and regulatory requirements, as well as familiarity with clinical trial processes and documentation. - Excellent interpersonal and communication skills, able to build relationships with clients and teams. - Demonstrated ability to manage multiple priorities and deliver on deadlines in a fast-paced environment. - A proactive, solutions-oriented mindset with the ability to drive decisions and lead initiatives. - Experience using clinical trial management software and EDC systems. Benefits - Flexibility: We encourage a work-life balance that allows employees to bring their best selves to work while being passionate about their lives outside work.
Title: MDS Solutions - Clinical Reimbursement Specialist Location: Fargo, North Dakota, United States Department: Administrative/Clerical Remote ID : 2026-4755 Category :Administrative/Clerical Job Description: Overview MDS Solutions, a division of Key Rehabilitation, is looking for fun, energetic, and self-driven team members to join our remote MDS division as a Clinical Reimbursement Specialist. Clinical Reimbursement Specialist (CRS) The Clinical Reimbursement Specialist (CRS) plays a critical role in supporting clients through specialized project work, including conducting RAI assessments, developing comprehensive care plans, and delivering targeted education and training to MDS Coordinators on the Resident Assessment Instrument (RAI) process. This work is performed in strict alignment with applicable laws, regulations, and company standards. The CRS also reviews reimbursement systems for PDPM and Case Mix to ensure accurate and optimized reimbursement. Additionally, the CRS provides support with interim long-term and short-term contract coordination, ensuring the smooth completion of these efforts About Us: At Key Rehab, we’re shaking up rehab services with a fresh, standout approach. We offer a wide range of services, stick to top-notch systems, and work in strategic locations to get the best results for our patients and support our clients' goals. We’re all about clear communication, using our deep experience to deliver therapy that's both effective and affordable. Our reputation is built on great patient care, happy clients and staff, and solid management. We are proud to exceed expectations for patients, families, healthcare providers, and businesses. We prioritize both exceptional patient care and the well-being of our employees. We are committed to delivering compassionate, results-driven therapy while offering the flexibility and comprehensive benefits needed to thrive in today’s healthcare environment. Our team is large enough to offer competitive pay and benefits but small enough to ensure personalized attention and support for your career aspirations. Whether you’re looking for a role that accommodates family commitments, travel plans, home projects, or future savings, we provide tailored solutions to fit your lifestyle. Join us and experience a workplace that values your individual needs and career goals. Come experience a rewarding career where you’re valued and supported every step of the way. We offer a creative, engaging, and flexible work environment, alongside a comprehensive benefits package designed to support your success and well-being: - Competitive salaries with bonus opportunities - Ample opportunities for promotion, transfer, and advancement - Work that is meaningful, fulfilling, and provides high job satisfaction - Reasonable working hours promoting work-life balance - Continuing education (CE) opportunities for ongoing professional development - Generous paid time off - Comprehensive health, dental, and life insurance packages - 401K with discretionary matching - Mileage and licensure reimbursements - Flexible Spending Account (FSA) and Health Savings Account (HSA) options Responsibilities - Serve as a trusted advisor to healthcare agencies and facilities, offering expert guidance and insights to optimize their operations. - Assist clients in assessing, planning, developing, and implementing systems and processes related to reimbursement, tailored to the specific needs and contracts established with each client. - Provide consulting services and technical expertise, including interim MDS management, ensuring providers receive the support they need to achieve optimal outcomes. - Stay up-to-date on professional standards of clinical care, federal and state regulations, QM measures, and the RAI process to ensure the delivery of accurate, compliant, and effective solutions. - Deliver high-quality, professional services that encompass reimbursement optimization, staff education, in-depth research, system analysis, creative problem-solving, and the presentation of actionable recommendations to clients. - Identify and address training needs, developing and conducting training sessions or in-service programs as requested by clients to enhance staff competency and performance. - Operate within the defined scope of work, maintaining strict adherence to client agreements and expectations. - Uphold client confidentiality and ensure full compliance with HIPAA regulations, safeguarding sensitive information throughout the engagement. Qualifications Minimum Qualifications: - Bachelor’s degree in nursing from an accredited college or university, with at least five (5) years of clinical experience, including 3+ years specializing in the RAI process. - Current and unrestricted RN ,along with active RAC-CT certification, ensuring adherence to industry standards and best practices. - Possesses exceptional critical thinking skills, with the proven ability to make informed decisions, demonstrate sound clinical judgment, and apply expert knowledge in quality improvement concepts and processes. - Demonstrates strong leadership abilities and excels in interpersonal communication, fostering collaboration, and guiding teams to achieve optimal clinical outcomes. Key Rehab is an equal opportunity employer/service provider.
Title: MDS Solutions - Clinical Reimbursement Specialist Location: Cedar Rapids, Iowa, United States Department: Administrative/Clerical ID: 2026-4759 Job Description: MDS Solutions, a division of Key Rehabilitation, is looking for fun, energetic, and self-driven team members to join our remote MDS division as a Clinical Reimbursement Specialist. Clinical Reimbursement Specialist (CRS) The Clinical Reimbursement Specialist (CRS) plays a critical role in supporting clients through specialized project work, including conducting RAI assessments, developing comprehensive care plans, and delivering targeted education and training to MDS Coordinators on the Resident Assessment Instrument (RAI) process. This work is performed in strict alignment with applicable laws, regulations, and company standards. The CRS also reviews reimbursement systems for PDPM and Case Mix to ensure accurate and optimized reimbursement. Additionally, the CRS provides support with interim long-term and short-term contract coordination, ensuring the smooth completion of these efforts About Us: At Key Rehab, we’re shaking up rehab services with a fresh, standout approach. We offer a wide range of services, stick to top-notch systems, and work in strategic locations to get the best results for our patients and support our clients' goals. We’re all about clear communication, using our deep experience to deliver therapy that's both effective and affordable. Our reputation is built on great patient care, happy clients and staff, and solid management. We are proud to exceed expectations for patients, families, healthcare providers, and businesses. We prioritize both exceptional patient care and the well-being of our employees. We are committed to delivering compassionate, results-driven therapy while offering the flexibility and comprehensive benefits needed to thrive in today’s healthcare environment. Our team is large enough to offer competitive pay and benefits but small enough to ensure personalized attention and support for your career aspirations. Whether you’re looking for a role that accommodates family commitments, travel plans, home projects, or future savings, we provide tailored solutions to fit your lifestyle. Join us and experience a workplace that values your individual needs and career goals. Come experience a rewarding career where you’re valued and supported every step of the way. We offer a creative, engaging, and flexible work environment, alongside a comprehensive benefits package designed to support your success and well-being: - Competitive salaries with bonus opportunities - Ample opportunities for promotion, transfer, and advancement - Work that is meaningful, fulfilling, and provides high job satisfaction - Reasonable working hours promoting work-life balance - Continuing education (CE) opportunities for ongoing professional development - Generous paid time off - Comprehensive health, dental, and life insurance packages - 401K with discretionary matching - Mileage and licensure reimbursements - Flexible Spending Account (FSA) and Health Savings Account (HSA) options Responsibilities - Serve as a trusted advisor to healthcare agencies and facilities, offering expert guidance and insights to optimize their operations. - Assist clients in assessing, planning, developing, and implementing systems and processes related to reimbursement, tailored to the specific needs and contracts established with each client. - Provide consulting services and technical expertise, including interim MDS management, ensuring providers receive the support they need to achieve optimal outcomes. - Stay up-to-date on professional standards of clinical care, federal and state regulations, QM measures, and the RAI process to ensure the delivery of accurate, compliant, and effective solutions. - Deliver high-quality, professional services that encompass reimbursement optimization, staff education, in-depth research, system analysis, creative problem-solving, and the presentation of actionable recommendations to clients. - Identify and address training needs, developing and conducting training sessions or in-service programs as requested by clients to enhance staff competency and performance. - Operate within the defined scope of work, maintaining strict adherence to client agreements and expectations. - Uphold client confidentiality and ensure full compliance with HIPAA regulations, safeguarding sensitive information throughout the engagement. Qualifications Minimum Qualifications: - Bachelor’s degree in nursing from an accredited college or university, with at least five (5) years of clinical experience, including 3+ years specializing in the RAI process. - Current and unrestricted RN ,along with active RAC-CT certification, ensuring adherence to industry standards and best practices. - Possesses exceptional critical thinking skills, with the proven ability to make informed decisions, demonstrate sound clinical judgment, and apply expert knowledge in quality improvement concepts and processes. - Demonstrates strong leadership abilities and excels in interpersonal communication, fostering collaboration, and guiding teams to achieve optimal clinical outcomes. Key Rehab is an equal opportunity employer/service provider.

