Associate, Clinical Trial Operations
Insmed Incorporated
8 hours ago
Remote
United States
Operations
Associate, Clinical Trial Operations (Clinical Operations team)
Reporting to the Senior Director, Clinical Trial Operations, provide operational support to the clinical study team (CST) to manage multiple clinical trials (all phases) and ensure compliance with SOPs, FDA regulations, GCP, and ICH guidelines.
Responsibilities
- Collect trial-related documents and maintain paper and electronic Trial Master File (TMF); assist with periodic TMF quality control checks per ICH/GCP requirements.
- Perform QC activities for Sponsor- and CRO-supported TMF at intervals in the project plan and/or SOPs and prior to TMF transition to Insmed at end of study; partner with Quality Assurance on audits/inspections for CRO/vendors for regulatory readiness and potential vendor contracts.
- Review clinical trial agreements, work orders, and site/vendor agreements; assist with invoice review/processing.
- Track and document site and sponsor training (e.g., study specific, drug, and program level).
- Participate in CST and vendor meetings; schedule meetings and draft/finalize action items; provide TMF status updates.
- Review CRO/vendor SOPs for applicability and conduct gap analysis.
- Coordinate activities for regulatory inspections (document prep/retrieval and support).
- Support vendor audits as needed and process vendor payments via Procurement system.
Qualifications
- Bachelor’s degree in life science, healthcare, or related field.
- 1+ year of experience in pharmaceutical/biotech.
Skills/Experience
- Clinical research experience; basic knowledge of GCP and ICH.
- Strong verbal and written communication; interpersonal/group skills.
- Flexibility and ability to work in a multi-functional, global matrix.
- Multi-tasking/prioritization.
- Collaborative approach to process development, issue resolution, and risk management.
- TMF experience (paper and eTMF) preferred.
Travel
- Occasional domestic/international travel (~25%).
Pay range: $87,000.00–$111,000.00 annual.
Reporting to the Senior Director, Clinical Trial Operations, provide operational support to the clinical study team (CST) to manage multiple clinical trials (all phases) and ensure compliance with SOPs, FDA regulations, GCP, and ICH guidelines.
Responsibilities
- Collect trial-related documents and maintain paper and electronic Trial Master File (TMF); assist with periodic TMF quality control checks per ICH/GCP requirements.
- Perform QC activities for Sponsor- and CRO-supported TMF at intervals in the project plan and/or SOPs and prior to TMF transition to Insmed at end of study; partner with Quality Assurance on audits/inspections for CRO/vendors for regulatory readiness and potential vendor contracts.
- Review clinical trial agreements, work orders, and site/vendor agreements; assist with invoice review/processing.
- Track and document site and sponsor training (e.g., study specific, drug, and program level).
- Participate in CST and vendor meetings; schedule meetings and draft/finalize action items; provide TMF status updates.
- Review CRO/vendor SOPs for applicability and conduct gap analysis.
- Coordinate activities for regulatory inspections (document prep/retrieval and support).
- Support vendor audits as needed and process vendor payments via Procurement system.
Qualifications
- Bachelor’s degree in life science, healthcare, or related field.
- 1+ year of experience in pharmaceutical/biotech.
Skills/Experience
- Clinical research experience; basic knowledge of GCP and ICH.
- Strong verbal and written communication; interpersonal/group skills.
- Flexibility and ability to work in a multi-functional, global matrix.
- Multi-tasking/prioritization.
- Collaborative approach to process development, issue resolution, and risk management.
- TMF experience (paper and eTMF) preferred.
Travel
- Occasional domestic/international travel (~25%).
Pay range: $87,000.00–$111,000.00 annual.