Senior Clinical Study Manager

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

📋 Description

• Formulate and implement strategies for clinical and outcomes research studies aimed at facilitating regulatory approvals and key strategic evidence initiatives.

• Create and design clinical protocols while managing the execution of clinical studies with minimal oversight.

• Collaborate closely with clinical research associates, clinical trial assistants, and data management teams to ensure the smooth conduct and execution of studies.

• Lead the trial's progress during site selection, site initiation, and throughout enrollment and follow-up phases.

• Offer guidance to monitors regarding their monitoring needs and supervise compliance activities related to the study.

• Assume a leadership role in external communications with investigators and study teams.

• Perform source data verification for clinical study data entered into the EDC system or recorded on case report forms.

⛳️ Requirements

• An advanced degree in a scientific or bioengineering field (M.S., Ph.D., or M.D.) with at least 5 years of experience in clinical research, or a Bachelor's degree in a scientific or bioengineering field with a minimum of 8 years of clinical research experience is preferred, or at least 10 years of clinical research experience with relevant training.

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

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

• Proven track record in developing protocols and informed consent forms, along with writing clinical sections for regulatory submissions.

• Demonstrated experience in conducting literature searches, reviews, and evaluations of scientific data.

• Exceptional interpersonal skills for interacting with physicians and other professionals both within and outside the organization.

• Familiarity with Good Clinical Practice ICH/GCP and other relevant regulations, alongside a fundamental understanding of clinical research and monitoring requirements.

• Experience in negotiating clinical research contracts and budgets.

• Ability to work effectively within cross-functional teams.

• Willingness to travel 25-40% based on business needs.

• Capability to manage multiple projects and prioritize effectively.

• Strong communication, presentation, and relational skills, with a keen attention to detail and organizational abilities.

• Quick learner with adaptability to changing requirements and a self-driven approach to gaining knowledge on various surgical specialties as relevant to clinical projects.

🏝️ Benefits

• Health insurance

• Flexible working hours

• Professional development opportunities