Seaporttherapeutics
Clinical Trial Manager
Boston, MA. Posted 3 months ago
The role
The Clinical Trial Manager leads the execution of clinical studies on schedule and on budget. This person manages CROs, vendors, and cross-functional study teams to deliver clinical development milestones.
What you will do
- Deliver studies on time, within budget and in compliance with SOPs, regulations and ICH/GCP guidelines
- Support external vendor selection and management and assist in RFP and vendor oversight plans
- Manage CROs and other vendors
- Provide input for the design of Informed Consent Forms, eCRFs, monitoring conventions, and edit checks
- Develop timelines and budgets for assigned studies
- Lead cross-functional study teams including external members, CROs and vendors
- Plan, negotiate, and manage site budgets and facilitate site contracting
- Develop and implement contingency and issue management plans
- Disseminate clinical trial communications and lead study and team meetings
- Interact with clinical research investigators, Key Opinion Leaders and sites
Required qualifications
- BA/BS degree in Health or Life Sciences
- Minimum 4+ years of experience or demonstration of equivalent capability in a Clinical Trials Manager role
- Exceptional communication and interpersonal skills
- Positive team orientated attitude
- Reliable, self-motivated, team player
- Detail oriented with excellent organizational skills
- Ability to effectively manage multiple tasks and competing priorities
- Creative problem solver
- Ability to travel is required
Nice to have
- CNS therapeutic experience
About the company
Seaport Therapeutics is a clinical-stage therapeutics company advancing the development of novel neuropsychiatric medicines. The company uses its proprietary Glyph technology platform to advance clinically validated mechanisms.