Senior Clinical Study Manager

New

JobgetherMedical devices

Based in United StatesFull-TimeSenior

Salary not disclosed

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Job Details

Experience: At least 5 years of clinical research experience; alternatively, a bachelor's degree in a relevant scientific or bioengineering discipline with at least 8 years of clinical research experience, or approximately 10 years of clinical research experience combined with relevant training.
Required Skills: Project Management

Have experience implementing, supporting, and managing medical device clinical trials.
Have significant knowledge of clinical research and/or outcomes research study design.
Have experience developing clinical protocols and informed consent forms and contributing clinical sections to regulatory submissions.
Have experience conducting literature searches, reviewing scientific evidence, and critically appraising clinical data.
Have working knowledge of ICH/GCP, clinical research regulations, and clinical monitoring requirements.
Have experience negotiating clinical research contracts and study budgets.
Have strong project management skills and the ability to manage multiple studies, projects, and shifting priorities.
Be able to lead and coordinate clinical project teams involving CRAs and CTAs.
Have an M.S., Ph.D., or M.D. in a scientific or bioengineering field and at least 5 years of clinical research experience; alternatively, a relevant bachelor's degree and at least 8 years of experience, or approximately 10 years of experience combined with relevant training.
Be willing and able to travel approximately 25–40% depending on business requirements.
Hospital environment experience and familiarity working with nurses and surgeons are preferred.
Knowledge of statistics, statistical methods, and experimental design is highly desirable.

Develop study concepts, designs, protocols, study outlines, and clinical research strategies with internal stakeholders, investigators, and KOLs.
Plan and execute clinical studies, including site selection, patient recruitment projections, study documentation, and IRB/EC submissions.
Develop and manage protocols, case report forms, informed consents, clinical trial agreements, and clinical study reports.
Conduct site qualification, initiation, interim monitoring, and close-out visits using on-site and remote approaches.
Monitor studies for regulatory and protocol compliance, data accuracy, and adherence to clinical monitoring plans.
Perform source data verification for clinical data recorded in EDC systems, case report forms, and data listings.
Track study progress, financial activities, site payments, and milestones, and provide status updates.
Collaborate with biostatisticians on data analysis, interpretation, clinical study reports, and scientific publications.
Support audit and inspection readiness, regulatory submissions, and 510(k) submissions.
Mentor junior Clinical Study Managers and guide CRAs and CTAs on monitoring and study execution.

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