Study Associate Manager

About the Role Assist in planning and execution of clinical studies under the supervision of the Study Manager in Clinical Operations, ensuring adherence to protocol, GCP, SOPs, FDA/EU/ICH guidelines, and CSOP. The role focuses on providing clinical trial management support to study teams and monitoring CRO/vendor performance to meet project goals and milestones.

What You'll Do

• Reconcile TMF document trackers generated by the CRO with the document archive; raise issues and propose remediation plans.
• Distribute key study documents to CROs and vendors as appropriate.
• Provide clinical administrative support: coordinating meetings, distributing agendas and minutes for study team meetings, AROs, CROs, and Investigator Meetings.
• Support Fair Market Value process in evaluating study budgets.
• Coordinate with Regulatory Operations to post trial information on public forums.
• Under supervision, review CRO-generated reports and elevate issues to the supervisor.
• Compile and maintain a monitoring review spreadsheet and CRO Oversight Monitoring outputs.
• Analyze study site metrics to identify potential concerns and escalate to the supervisor; track metrics such as site start-up, investigator/site performance, recruitment, regulatory documents, TMF filing and QC activities.
• Create/maintain spreadsheets to track other items.
• Work with Insurance Brokers to obtain study site insurance; provide tracking/oversight to vendors handling lab logistics and other vendors.
• Participate in training and propose areas for improvement; contribute to individual career development planning.

What We're Looking For

• Education: Bachelor’s Degree (preferred in Life Sciences) with relevant clinical development experience required.
• Experience: 2+ years with a Bachelor's degree in clinical development or related fields; experience in clinical or basic research within a Pharmaceutical company, Medical device/Diagnostic company, ARO or CRO. CRA experience preferred; time spent in a medical environment is relevant.
• Travel: Ability to travel up to 5% of the time; in-house office position with occasional travel.
• Skills: Strong organization, communication, and documentation management; familiarity with TMF, CRO oversight, GCP/ICH, regulatory postings, and budget tracking.

Nice to Have

• Additional experience with regulatory submissions, data management systems, or process improvement initiatives.