Senior Clinical Trial Manager
Cambridge, MA (remote across the East Coast)
Attractive basic + bonus + stock option + Kaiser Health Insurance
Albion Rye Associates are delighted to of been assigned as the exclusive recruitment partner to a small, growing Immuno-oncology focused Biotech with a rich Phase II and Phase III pipeline.
- Develop, coordinate, and implement research and administrative strategies essential to the successful management of phase II, III, and IV clinical trials research projects conducted by principal investigator(s); perform a variety of duties involved in the organization, documentation and compilation of clinical research data.
- Follow established guidelines in the collection of clinical data and administration of clinical trials; assist in the determination guidelines for new protocols. Assist principal investigator and other team members in the development of plans, time lines, and processes for clinical research studies, contribute to the ongoing analysis and modification of protocols; recommend amendments to study protocols as appropriate. Confer with site coordinators and physicians to explain protocol and elicit compliance with regulations; assure adherence to Federal Drug Administration and protocol guidelines; identify potential problems and/or inconsistencies and take action as appropriate. Coordinate and lead the work of the research team and provide feedback to staff's supervision on a routine basis.
- Participate in conjunction with the principal investigator in the final negotiations of trial budget and contract.
- Prepare a variety of narrative and analytical reports, documents, and correspondence for contracting agencies, team members, participating departments and senior management regarding trial status; recommend corrective action as necessary.
- Perform other related duties incidental to the work described herein.
- The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.
To be considered for this position, it would be advantageous to:
- Have a University degree / Bachelors degree in a related subject area, preferably in medical or biological science, or one related to Clinical Research.
- Possess a minimum of 3 years operational clinical trial experience in a global Study Management role within Clinical Development, as well as an excellent knowledge of ICH-GCP.
- Have experience of working with and delivering through strategic partners and 3rd party vendors.
- Be fluent in written and spoken English
This project is being managed exclusively via Albion Rye Associates - for more information, please reach out to Jake Byrne, Managing Director.