Senior Clinical Study Manager

This is a fully remote position, open to applicants in California.

📋 Description

• This role requires a candidate with comprehensive experience in supporting evidence generation strategies and executing clinical studies.

• The Senior Clinical Study Manager (Level 4) will formulate and implement strategies for clinical and outcomes research studies to facilitate regulatory approvals and essential strategic evidence initiatives.

• As a member of the Clinical Affairs team, this position will entail collaborating with key stakeholders to design and create clinical protocols, as well as executing clinical studies (both pre-market and post-market) with minimal supervision.

• The selected candidate will closely collaborate with clinical research associates (CRAs), clinical trial assistants (CTAs), and data management teams during the study's conduct and execution, along with biostatisticians to review and interpret clinical study results, develop clinical study reports, and support the preparation of clinical publications.

• Throughout the trial execution, the Clinical Study Manager will propel the trial's progress during site selection, site initiation, enrollment, and follow-up.

• The Clinical Study Manager will provide clear guidance to monitors regarding monitoring requirements and oversee compliance activities related to the study.

• Additionally, the Clinical Study Manager will assume a leadership role in external communications with investigators and study teams.

• The ideal candidate will have a background in managing multi-center, premarket studies in the United States (IDE for 510k or PMA submissions) and will be skilled in utilizing resources to research and define research topics, along with providing recommendations on clinical trial strategies.

• The candidate should also have experience in reviewing, interpreting, and summarizing clinical literature.

⛳️ Requirements

• Prior experience in implementing, supporting, and managing medical device trials.

• Extensive knowledge of clinical and/or outcomes research study design.

• Strong familiarity with protocol and informed consent form (ICF) development, as well as writing clinical sections for regulatory submissions.

• Proven experience in conducting literature searches, reviews, and appraisals of scientific data.

• Exceptional ability to interact with physicians and other professionals both within and outside the organization.

• Knowledge of Good Clinical Practice (ICH/GCP) and other relevant regulations, along with a fundamental understanding of clinical research and monitoring requirements.

• Experience in negotiating clinical research contracts and budgets.

• Ability to work effectively as part of cross-functional teams.

• Willingness to travel 25-40% or as required by business needs.

• Capability to manage multiple projects and/or prioritize competing demands.

• Excellent communication, presentation, and interpersonal skills, with a keen attention to detail and organizational abilities.

• Capacity to learn rapidly, adapt to changing requirements, and self-educate on various surgical specialties as they relate to clinical projects.

• Ability to lead project teams consisting of CRAs and CTAs, while supporting management with relevant study updates.

• Demonstrates a strong work ethic to meet aggressive timelines or manage multiple projects as necessary, with a problem-solving approach.

🏝️ Benefits

• Health insurance

• 401(k) matching

• Flexible work hours

• Paid time off

• Professional development opportunities