Clinical Operations Leader
Apnimed conducts clinical trials through CROs and investigators at academic institutions and clinical trials sites. Apnimed typically develops trial protocols and associated documents, and works with the CROs/sites to modify and implement these protocols. We seek an individual with extensive clinical trials management experience to assist in the full process of trial development and implementation, including reviewing protocols and other trial documents, assisting in interviewing and selecting CROs and trial sites, assisting sites in trial preparation and initiation, monitoring of CROs and sites during the conduct of trials, and facilitating data analysis.
Some key responsibilities include:
- Oversight of clinical study conduct including study timeline and metrics management, vetting and oversight of external vendors.
- Work with Apnimed medical team to design clinical trial protocols
- Prepares and/or reviews study-related documents (e.g., Monitoring Plan, Laboratory Manual, Patient Diary, Pharmacy Manual, CRF Completion Guidelines, etc.).
- Prepares/reviews site study documents (i.e., site-specific informed consent, study tools/worksheets, investigator contracts, and site payments).
- Assists in development and management of study budget and maintains it within financial goals; reviews and approves clinical invoices against approved budget.
The candidate will have direct experience in working with CROs or investigators, including monitoring conduct of trials, and will be comfortable in working closely with colleagues in a small, flexible and fast-moving environment. We are amenable to a remote work arrangement. Some travel will be necessary, depending on the broader medical situation. This position reports to the Chief Medical Officer.
Position title and rank are open and dependent on experience. Apnimed offers competitive compensation, including equity and full benefits.
If interested, please submit a resume and cover letter to firstname.lastname@example.org