Senior Clinical Study Manager

Contact: Alexandra Spink -
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.

• Bachelors 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.