Clinical Study Manager III

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 innovative clinical research initiatives. This role involves developing and implementing strategies for clinical and outcomes research, ensuring regulatory compliance, and managing clinical studies from inception to completion. You'll collaborate with a diverse team of professionals, including clinical research associates and biostatisticians, to drive successful study outcomes. If you have a passion for clinical research and a track record of managing complex studies, this is a fantastic opportunity to make a significant impact in the field.

Qualifications

• Extensive experience in managing clinical studies and evidence generation.
• Strong background in regulatory compliance and clinical protocol development.

Responsibilities

• Lead clinical research activities and manage study progress.
• Collaborate with stakeholders to develop study designs and protocols.
• Conduct monitoring visits and ensure compliance with regulations.

Skills

Clinical Study Management

Evidence Generation Strategy

Regulatory Compliance

Clinical Protocol Development

Data Analysis

Budget Management

Literature Review

Education

Bachelor's Degree in Life Sciences

Master's Degree in Clinical Research

Tools

Clinical Trial Management Systems (CTMS)

Electronic Data Capture (EDC)

Job description

Job Description

Primary Function of the Position

This position requires a candidate with extensive experience in evidence generation strategy and the execution of clinical studies. The Clinical Study Manager-3 (CSM III) will develop and implement strategies for clinical and outcomes research to support regulatory approvals and strategic evidence initiatives. As part of the Clinical Affairs team, the role involves designing and developing clinical protocols and managing clinical studies (pre-market or post-market) with minimal supervision. The candidate will collaborate closely with clinical research associates (CRAs), clinical trial assistants (CTAs), data management teams, biostatisticians, and external investigators.

The CSM will oversee trial progress during site selection, initiation, enrollment, and follow-up, providing guidance on monitoring needs and ensuring study compliance. The role also involves external communication with investigators and study teams. The ideal candidate will have experience managing premarket studies in the U.S., researching and scoping research topics, and providing clinical trial strategy recommendations. Experience in reviewing, interpreting, and summarizing clinical literature is also expected.

Essential Job Duties

• Lead assigned clinical research activities.
• Collaborate with internal stakeholders, investigators, and KOLs to develop and review study designs, protocols, and outlines.
• Plan and execute clinical studies, including site selection, recruitment projections, and document creation (protocols, case report forms, informed consents, study reports).
• Organize IRB/EC submissions and ensure successful progress.
• Conduct clinical studies on schedule and within budget, maintaining high quality and compliance.
• Perform on-site and remote monitoring visits, including qualification, initiation, interim, and close-out visits.
• Ensure regulatory and protocol compliance through source data verification and data accuracy checks.
• Coordinate with sites for audits and inspections, ensuring readiness.
• Negotiate contracts and budgets with external vendors and sites.
• Track study progress and provide status reports.
• Collaborate with biostatisticians on data analysis, interpretation, and report development.
• Manage site payments and financial tracking tools.
• Organize study meetings and activities.
• Mentor junior staff and guide CRAs and CTAs.
• Adhere to SOPs, GCP, and other regulatory requirements.
• Conduct literature searches, appraise scientific literature, and write summaries to inform clinical strategies.
• Review and update SOPs for continuous improvement.
• For post-market studies, collaborate with commercial teams to understand market trends and support business goals.
• Provide scientific expertise for outcomes research and reimbursement considerations.
• Assist in preparing manuscripts, abstracts, and presentations for scientific dissemination.
• Support regulatory submissions and respond to agency questions regarding clinical studies.