Senior Clinical Study Manager
RemoteUnited States
Job Summary
Develop and execute strategies for clinical and outcomes research studies to support regulatory approvals and key strategic evidence initiatives. Collaborate with internal stakeholders, investigators, and key opinion leaders to design protocols, drive site selection, and manage multi-center pre-market studies from initiation through enrollment and follow-up. Independently conduct clinical study monitoring, perform source data verification in EDC systems, and liaise with external vendors to negotiate contracts and budgets. Lead site qualification, initiation, and close-out visits while ensuring regulatory and protocol compliance. Work with biostatisticians to interpret results, develop clinical study reports, and critically appraise scientific literature to support publications and research strategies. Mentor junior managers and guide CRAs and CTAs on monitoring needs. Support regulatory submissions for 510k or PMA approvals and address regulatory body questions on study design and results.
Required Qualifications
- extensive experience supporting evidence generation strategy and execution of clinical studies
- develop and execute strategies for clinical and outcomes research studies to support regulatory approvals and key strategic evidence initiatives
- working with key stakeholders to design and develop clinical protocols and execute clinical studies (pre-market or post-market studies), with minimal supervision
- work closely with clinical research associates (CRAs), clinical trial assistants (CTAs) and data management for the conduct and execution of the study
- work closely with biostatisticians to review and interpret results of clinical studies
- develop clinical study reports
- support the development of clinical publications
- drive the progress of the trial during site selection, site start-up and through enrollment and follow-up
- provide guidance to the monitors about monitoring needs
- oversee compliance work on the study
- take a leadership role in external communication with investigators and study teams
- experience previously managing multi-center, premarket studies in the United States (IDE for 510k or PMA submissions)
- utilizing resources to research and scope research topics and to provide recommendations on clinical trial strategy
- experience reviewing, interpreting and summarizing clinical literature
- Previous experience implementing, supporting and managing medical device trials
- Significant knowledge of clinical and/or outcomes research study design
- Strong experience in protocol and ICF development, writing clinical section(s) for regulatory submission
- Strong experience in conducting literature searches, reviews and appraisal of the scientific data
- Excellent ability to interact with physicians and other professionals inside and outside the company
- Knowledge of Good Clinical Practice ICH/GCP and other applicable regulations
- fundamental understanding of clinical research and monitoring requirements
- Experience negotiating clinical research contracts and budgets
- Must be able to work effectively on cross-functional teams
- Must be able to travel 25-40% or depending on business requirements
- Must be able to manage multiple projects and/or balance competing priorities
- Strong communication, presentation and interpersonal skills with high attention to detail and organization
- Ability to learn quickly, adapt to shifting requirements, and self-educate on different surgical specialties as applicable to clinical projects
- Ability to lead project team consisting of CRAs and CTAs and support management with relevant study updates
- Exhibits strong work ethic to help meet aggressive timelines or multiple projects when necessary with a problem-solving mindset
- Minimum Advanced degree in a scientific/bioengineering field (M.S., Ph.D. or M.D.) with a minimum of 5 years of experience in clinical research
- Bachelor's degree in a scientific/bioengineering field with a minimum of 8 years of experience in clinical research
- minimum of 10 years of experience in clinical research with relevant training
- show current proof of vaccination against certain diseases including COVID-19
Desired Qualifications
- Minimum Advanced degree in a scientific/bioengineering field (M.S., Ph.D. or M.D.) with a minimum of 5 years of experience in clinical research, or Bachelor's degree in a scientific/bioengineering field with a minimum of 8 years of experience in clinical research is preferred
- Comfortable in a hospital environment, experience working with nurses and surgeons preferred
- Understanding of statistics, statistical methods, and design of experiment is strongly preferred
- Extensive experience with close and independent management of pre-market clinical studies (First Human Use or IDE) used for regulatory submissions
- Strong track record of KOL management for multi-center studies
- Experience working on global or multi-national studies
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