Clinical Trial Manager
Location: San Diego, CA
Clinical Trial Manager | Dynamic Biopharmaceutical Company
This Clinical Trial Manager search is being conducted on behalf of our biopharmaceutical client that is focused on neurological disorders.
In this role, one will be responsible for leading and managing the operational activities to support planning, initiation, conduct and close out of the domestic and global Gene Therapy and Neurology Clinical Studies. One will manage studies using Contract Research Organizations (CROs) as well as managing internally run studies.
ADDITIONAL INFORMATION ABOUT THIS COMPANY AND ROLE:
Voted one of the top places to work in 2018.
Our client is committed to their goals and making a difference.
One must have experience in Gene Therapy and Neurology clinical trials.
HIGHLIGHTS OF RESPONSIBILITIES:
Ensuring clinical studies are conducted in compliance with FDA regulations, ICH guidelines, and NBI SOPs and policies.
Serving as primary point of contact for clinical operations aspects of assigned clinical studies.
Understanding of gene therapy and neurology clinical studies to participate in technical and study design discussions and providing input to clinical trial outlines, protocols, and clinical study reports.
Managing contract research organizations (CROs) and other contract service providers (CSPs) for assigned studies.
Leading study team meetings and managing study issues. Developing and managing study timelines in accordance with corporate goals. Identifying barriers to enrollment and developing recruitment solutions.
Managing internally run studies (without CROs) including the management of CRAs and developing monitoring plans, on-site monitoring guidelines, forms, tools and performing onsite monitoring and co-monitoring visits, as necessary.
DESIRED SKILLS AND QUALIFICATIONS:
BS or MS, or RN with a minimum of 5 years of CRA and Clinical Trial Manager experience in pharmaceutical industry/ Biotech or CRO.
Must have detailed knowledge of clinical drug development process including working knowledge of ICH, GCPs, and FDA regulations.
Must have previous experience in a Clinical Trial Manager role.
Must have experience in managing CROs (domestic and international).
Must have prior onsite monitoring experience.
To learn more about this amazing opportunity, contact a member of our team at 267-483-5233 or firstname.lastname@example.org.
The Bandish Group, LLC
Life Sciences Executive Search
1432 Easton Road, Suite 2B
Warrington, PA 18976