Senior Clinical Trial Associate
About the role
We're seeking a Senior Clinical Trial Associate to join our Clinical Operations Team. Reporting to the Director, Clinical Trial Operations, you'll provide operational support for multiple clinical trials across all phases, ensuring compliance with SOPs, FDA regulations, GCP, ICH guidelines, and more.
Responsibilities
- Drive clinical trial excellence by supporting the CST with operational tasks throughout the study lifecycle.
- Create and distribute study materials, including essential documents, presentations, and reports.
- Manage site and sponsor training, maintaining training matrices for the CST.
- Participate in clinical study team and vendor meetings, drafting and finalizing agendas and action items.
- Review CRO/Vendor SOPs for applicability and perform gap analyses.
- Support inspection readiness by coordinating document retrieval and other activities.
- Participate in study operations planning, risk assessments, and mitigation strategies.
- Ensure the integrity of the Trial Master File (TMF) and cross-functional collaboration.
- Coordinate the collection and maintenance of essential documents and the electronic TMF.
- Assist in preparing TMF Health Reports and updating TMF metrics.
- Review and assist in processing clinical trial agreements, CRO and vendor contractual documents, work orders, and other site/vendor agreements.
- Support the review and processing of invoices related to clinical trial agreements and CRO/vendor scopes of work.
Requirements
- Minimum Bachelor’s degree in a life sciences, healthcare, or related field with at least 3 years of progressive experience in a Clinical Operations role.
- Proven experience with TMF, both paper and electronic, including Veeva.
- Strong knowledge of clinical research process, including FDA and local regulatory requirements.
- Experience with collaborating with CROs and third-party vendors to ensure successful study execution.
- Excellent communication, conflict management, and organizational skills with a strong attention to detail.
- Ability to train and mentor new hires and colleagues.
Qualifications
- Minimum Bachelor’s degree in a life sciences, healthcare, or related field with at least 3 years of progressive experience in a Clinical Operations role.
- Proven experience with TMF, both paper and electronic, including Veeva.
- Strong knowledge of clinical research process, including FDA and local regulatory requirements.
- Experience with collaborating with CROs and third-party vendors to ensure successful study execution.
- Excellent communication, conflict management, and organizational skills with a strong attention to detail.
- Ability to train and mentor new hires and colleagues.
Skills
- Strong knowledge of clinical research process, including FDA and local regulatory requirements.
- Experience with collaborating with CROs and third-party vendors to ensure successful study execution.
- Excellent communication, conflict management, and organizational skills with a strong attention to detail.
- Ability to train and mentor new hires and colleagues.
Benefits
Life at Insmed offers comprehensive medical, dental, and vision coverage, mental health support, and generous paid time off policies. We also provide fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration. Additionally, we offer a 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP).
Pay
$113,000.00 - $143,500.00 Annual