Manager, Clinical Study Operations
New
B
Beacon BiosignalsBiotech, Medtech, Pharma
Remote / Boston, MA; The Clinical Study Operations group is distributed across American and European time zones., American and European time zonesFull-TimeManager
Salary$115,000 – $135,000
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Job Details
- Experience
- 6+ years of experience in clinical trial operations
- Required Skills
- GCPAsana
Requirements
- 6+ years of experience in clinical trial operations in biotech, medtech, or pharma.
- Bachelor's or advanced degree in a clinical or scientific field.
- 1-2+ years of direct people management experience.
- Demonstrated ownership of the clinical trial lifecycle: start-up, recruitment strategy, enrollment, monitoring, data cleaning, and close-out.
- Working knowledge of GCP, FDA and global regulatory requirements.
- Experience with SOP development and QMS practices (e.g., Qualio).
- Experience working with CROs and vendors: selection support, day-to-day oversight, and relationship management.
- Ability to travel up to 15% of the time.
- Comfortable operating asynchronously in a remote-first, distributed organization.
- Strong cross-functional communication skills.
Responsibilities
- Manage a group of direct reports across Clinical Study Operations.
- Oversee ClinOps activities on studies from feasibility and site start-up through data collection, monitoring, and close-out.
- Set clear expectations, coach day-to-day execution, and escalate risks to leadership.
- Drive domain-level ClinOps initiatives including process standardization, tooling, and data quality.
- Represent ClinOps in BD conversations, feasibility discussions, and Investigator Meetings.
- Maintain and improve ClinOps SOPs, work instructions, and CTMS practices.
- Manage working relationships with sponsors and CROs.
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