Senior Clinical Trials Associate

4 weeks ago

London, United Kingdom Seagen Full time

Position Summary:
Support clinical study teams in the execution of clinical trials with dotted line reporting to the study Protocol Lead (PL). Primary responsibilities include establishing and maintaining the Trial Master File (electronic [eTMF] or paper TMF) and Clinical Trial Management System (CTMS) in an inspection-ready state, assisting with site management, initiating collection, review, and tracking of essential documents throughout the life of the trial, contributing to the production and distribution of study materials and site communications.

Principal Responsibilities:

- Assist in establishment and maintenance of the Trial Master File (system or file room) in inspection-ready state
- Communicate directly with sites to drive collection of essential documents from start-up through study closure
- Ensure accurate and timely review and filing of clinical trial related materials
- Perform and support QC reviews of study, country and site files, including issue resolution
- Produce reports and status metrics as requested
- Establish and maintain the RCTO System in inspection-ready state
- Maintain accurate and up-to-date site, vendor and internal study team contact
information
- Track study progress and produce reports and status metrics as requested
- Assist with Investigational Product reconciliation
- Assist study team by performing administrative tasks as needed
- Coordinate and run meetings, both in-house and remote by means of virtual conferencing system
- Prepare meeting agendas, minutes, and track action items
- Operate and navigate within clinical trial systems including but not limited to TMF,
CTMS, ECMS, EDC
- Initiate and/or contribute to the creation and maintenance of documents and plans for assigned clinical studies including but not limited to training materials, study binders, plans, presentations, and reports
- Ensure timely distribution of clinical trial related materials to sites, study team, field
CRAs and vendors
- With increasing independence, perform the following:

- Data cleaning activities and data listings review
- Informed Consent document review
- Site/Site Management Organization Regulatory Monitoring
- Assist in preparation and follow-up of company-sponsored site quality audits as well as
regulatory authority inspections
- Increase basic knowledge of scientific medical and therapeutic information
- Primarily works and collaborates with Protocol Lead, internal and external study staff, vendor staff, and peers
- May provide training activities for new and current staff
- Works mostly independently and on assignments that are moderately complex in nature where judgment is required in resolving routine problems and making routine recommendations
- Adhere to CFR, GCP/ICH, company policies, Clinical Development Operations and project specific quality documents (e.g., SOPs, work practices, training guides)

Qualifications:

- A minimum of 2 years clinical trial experience, preferably within the pharmaceutical or biotechnology industry
- Basic knowledge and understanding of Essential Documents, CFR and GCP/ICH.
- Proficiency with technological systems (Microsoft Office, TMF, CTMS, EDC, ECMS, Zoom)
- Fundamental understanding of filing systems and organizational tools

**Education**:

- BS/BA or equivalent preferred
- #LI-LO1_

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