Contact: Alexandra Spink - aspink@penfieldsearch.com
No 3rd party candidates
The Sr. Clinical Study Manager role is responsible for managing the overall clinical operations of pre-clinical and clinical diagnostic trials, including study planning, budgeting, resource management, and, when applicable, oversight of contract research organizations (CROs).
The Sr. Clinical Study Manager will provide operational leadership and mentorship to Clinical Operations staff and will collaborate closely with cross-functional teams to ensure clinical studies are executed according to established timelines, budgets, quality standards, and regulatory requirements.
This is a remote position with travel to company headquarters and/or clinical sites on a minimal and as-needed basis.
Key Responsibilities
- Manage the full scope of clinical studies from planning through completion.
- Oversee Clinical Operations staff, including regular and contract personnel, and manage all aspects of the clinical operational plan.
- Develop study-related documents and provide overall direction to clinical sites, including support for protocol development and implementation.
- Create, manage, and monitor clinical study budgets.
- Develop contingency plans and risk-mitigation strategies for clinical studies.
- Manage study timelines, milestones, resources, and deliverables to ensure successful execution.
- Oversee and manage CRO activities, when applicable.
- Develop and maintain effective communication across functions, including Executive/Leadership, Research & Development, Medical Affairs, Scientific Affairs, Regulatory Affairs, Finance, and Commercial teams.
- Provide regular reporting on study timelines, milestones, budget, and operational performance, with recommendations for adjustments as needed.
- Support compliance with applicable regulatory requirements, company procedures, and clinical research standards.
- Provide guidance, oversight, and mentorship to Clinical Operations team members.
Essential Qualifications
- Bachelor's degree in a scientific discipline or equivalent combination of education and experience.
- 8+ years of clinical research experience within the medical device, in vitro diagnostics (IVD), biotechnology, or pharmaceutical industry.
- Working knowledge of applicable FDA regulatory requirements related to clinical research.
- Strong oral and written communication skills.
- Strong technical writing and documentation skills.
- Ability to effectively collaborate with cross-functional teams and external partners.
- Ability and willingness to travel up to 20% under normal operating conditions.
Preferred Qualifications
- At least 3 years of Clinical Research Associate (CRA) experience and 3 years of clinical study management experience.
- Experience managing in vitro diagnostic clinical trials.
- Experience with infectious disease and/or oncology clinical trials.
- Experience managing clinical studies through CROs and external clinical partners.
- Experience developing and implementing clinical operational plans, budgets, timelines, and risk-mitigation strategies.
