Senior Clinical Study Manager

Intuitive; Sunnyvale (CA); On-site; USD 90,000 - 150,000; Full time

Job summary

An established industry player is seeking a Clinical Study Manager to lead and execute clinical research studies. This pivotal role involves developing strategies for clinical and outcomes research, collaborating with various stakeholders, and ensuring compliance with regulatory standards. The ideal candidate will possess extensive experience in managing clinical studies, from site selection to data analysis, and will have a strong background in clinical protocol development. Join a dynamic team that values innovation and scientific excellence, where your contributions will directly impact the advancement of healthcare solutions.

Benefits

Health Insurance

401(k) Plan

Paid Time Off

Professional Development Opportunities

Flexible Work Hours

Qualifications

• Extensive experience in clinical study management and evidence generation.
• Strong understanding of regulatory guidelines and compliance.

Responsibilities

• Lead and execute clinical studies, ensuring quality and compliance.
• Collaborate with stakeholders to develop study protocols and documents.

Skills

Clinical Study Management

Regulatory Compliance

Data Analysis

Clinical Protocol Development

Communication with Investigators

Education

Bachelor's Degree in Life Sciences

Master's Degree in Clinical Research

Tools

Clinical Trial Management Systems (CTMS)

Statistical Analysis Software

Job description

Job Description

Primary Function of the Position

This position requires a candidate with extensive experience in evidence generation strategy and execution of clinical studies. The Clinical Study Manager-4 (CSM IV) will develop and execute strategies for clinical and outcomes research studies to support regulatory approvals and key strategic evidence initiatives. As part of the Clinical Affairs team, this role will work with key stakeholders to design and develop clinical protocols and execute clinical studies (pre-market or post-market), with minimal supervision. The candidate will collaborate closely with clinical research associates (CRAs), clinical trial assistants (CTAs), and data management teams during the conduct and execution of studies, as well as with biostatisticians to review and interpret clinical data, develop study reports, and contribute to clinical publications. During trial execution, the CSM will oversee site selection, start-up, enrollment, and follow-up, providing guidance to monitors and ensuring compliance. The role also involves external communication with investigators and study teams. The ideal candidate will have experience managing premarket studies in the United States, researching and scoping research topics, and providing recommendations on clinical trial strategies, as well as reviewing and summarizing clinical literature.

Essential Job Duties

1. Lead assigned clinical research activities independently.
2. Partner with internal stakeholders, investigators, and KOLs to develop and review study designs, protocols, and outlines, and drive related initiatives.
3. Plan and execute clinical studies, including site selection, patient recruitment projections, and creation of study documents (protocols, case report forms, informed consents, clinical trial agreements, study reports), and manage IRB/EC submissions.
4. Conduct clinical studies on schedule and within budget, ensuring high quality and compliance.
5. Perform site qualification visits, initiation visits, monitoring visits, and close-out visits, both on-site and remotely.
6. Monitor clinical studies to ensure regulatory and protocol compliance, data accuracy, and adherence to the clinical monitoring plan.
7. Complete source data verification in accordance with regulatory standards.
8. Coordinate with sites for audits and inspections, ensuring readiness for sponsor audits.
9. Negotiate contracts and budgets with external vendors and sites, in collaboration with legal and management teams.
10. Track study progress and provide regular status updates.
11. Collaborate with biostatisticians on data analysis, interpretation, and the development of clinical study reports and scientific publications.
12. Manage study finances, including site payments and tracking tools.
13. Organize and lead study meetings and activities.
14. Mentor junior staff such as other clinical study managers, CRAs, and CTAs.
15. Ensure compliance with SOPs, GCP, and other regulatory guidelines (US and OUS).
16. Conduct literature searches and appraise scientific literature to stay informed and identify evidence gaps.
17. Write clinical summaries to support research and clinical strategy development.
18. Review and update Clinical Operations SOPs for process improvements.
19. For post-market research, collaborate with commercial teams to understand market trends and support business goals.
20. Provide scientific expertise to the Health Economics and Outcomes Research department for outcomes research and reimbursement code identification.
21. Assist in preparing manuscripts, abstracts, and presentations for scientific dissemination.
22. Support regulatory submissions and address agency questions regarding clinical study design and results.