What are the responsibilities and job description for the Clinical Trial Manager position at seaporttherapeutics?
Clinical Trial Manager
Seaport Therapeutics is a clinical-stage biopharmaceutical company advancing the development of novel neuropsychiatric medicines in areas of high unmet patient needs. We are seeking a Clinical Trial Manager to join our Development team. The Clinical Trials Manager (CTM) is responsible for leading the execution of clinical studies on schedule and on budget.
The Company has a proven strategy of advancing clinically validated mechanisms previously held back by limitations that are overcome with its proprietary GlyphTM technology platform. All the therapeutic candidates in its pipeline of first and best-in-class medicines are based on the Glyph platform, which is uniquely designed to enable oral bioavailability, bypass first-pass metabolism and reduce hepatotoxicity and other side effects. Seaport is led by an experienced team that was involved in inventing and advancing KarXT and other neuropsychiatric medicines and are guided by an extensive network of renowned scientists, clinicians and key opinion leaders across neurological specialties. For more information, please visit www.seaporttx.com
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.
Requirements:
- 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
- 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
- CNS therapeutic experience strongly preferred
- This is a hybrid role, in the seaport of Boston with three days in office required
