greenhouse
Clinical Trial Manager
Seaport Therapeutics
Boston, USA
Full-time
Mid · 4+ years experience
Hybrid
USD 133000-150000 yearly / year
Discovered 1 weeks ago
Free
Job Fit Check
Base Career helps you apply smarter for this job.
?%
Ready to ScanFull Job Posting
Key Responsibilities
- Accountable for project related efforts for the delivery of studies that are critical to a product’s clinical development, ensuring that they are completed on time, within budget and in compliance with SOPs, regulations and ICH/GCP guidelines.
- Supports external vendor selection and management process and assists in the development of RFP’s and vendor oversight plans.
- Responsible for management of CROs and other vendors
- Provide input for the design of the Informed Consent Form(s), eCRFs, monitoring conventions, edit checks, etc.
- Develop timelines and budgets for assigned studies and is responsible for delivery to both quality and agreed timelines.
- Project leadership of the cross-functional study team, including external team members, CROs and vendors.
- Plan, negotiate, and manage site budgets as well as facilitate site contracting process.
- Develop and implement robust contingency and issue management plans to solve complex issues that impact study milestones.
- Disseminate clinical trial communications to all functional groups and leads study and team meetings.
- Interact with clinical research investigators, Key Opinion Leaders and sites.
- May interact with Senior Management to report on progress of milestones.
- Oversight of study team and site training
- Facilitation of Quality processes and Quality Assurance interactions for assigned project(s)
- Management of study drug distribution and accountability processes and documentation
- Oversight of study start-up, study management, data cleaning, and study closeout activities
- Responsible for final study files and documentation, including TMF, final TLFs, and final study data archival
- Provides review, assistance or leadership for the development and writing of study protocols, study plans, CRFs, informed consent forms.
Qualifications
- BA/BS degree in Health or Life Sciences required
- Minimum 4+ years of experience or demonstration of equivalent capability in a Clinical Trials Manager role
Apply for this job in 1 click
Skip the repetitive application forms
Install the Base Career Chrome Extension and autofill job applications across major job boards with your profile.
Trusted by over 500,000 job seekers on Base Career
More from this employer
More jobs at Seaport Therapeutics
Associate Director, Drug Substance Process Development
Boston, USA
Discovered YesterdayFull-time
Senior Director, Clinical Development
Boston, USA
Discovered 1 weeks agoFull-time
Senior Director, Analytical Research & Development
Boston, USA
Discovered 1 weeks agoFull-time
Bio-Analytical Co-op-Northeastern Students
Boston, USA
Discovered 1 weeks agoInternship
Associate Director, Quality Assurance - CMC
Boston, USA
Discovered 1 weeks agoFull-time
Director, Clinical Quality Assurance
Boston, USA
Discovered 1 weeks agoFull-time
Associate Director, Program Manager
Boston, USA
Discovered 1 weeks agoFull-time