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.
Experience in Phase I-IV Pharmaceutical Drug Trials strongly preferred, with emphasis on Phase III.
Position title and rank are open and dependent on experience. Apnimed offers competitive compensation, including equity and full benefits.
Education and experience:
- BA/BS required
- 5 to 8 years of experience in clinical trial leadership within a pharmaceutical company, CRO, clinical site network or similar organization required.
- Experience or knowledge of clinical trial vendors, tools, and methods.
- Knowledge of current regulatory requirements and guidelines governing clinical research.
- Understanding of clinical trials, relevant knowledge of GCP/ICH and applicable global regulations with regard to trial optimization strategies and tactics.
- Direct experience in the biotech/pharmaceutical industry or related field strongly preferred
- Proven track record of leading and driving business process transformation
- Health care business acumen with a comprehensive understanding of the pharmaceutical industry preferred
What Apnimed Offers:
- 401(k) with company match
- Generous time off for vacation
- Flexible working environment
- Motivated and experienced team
- Company located in Cambridge, MA, but remote workers are welcomed