Dermavant Sciences is a clinical-stage biopharmaceutical company focused on developing innovative therapies for inflammatory skin diseases and medical dermatologic conditions. We are passionate and dedicated to realizing the full potential of biomedical research and to developing and commercializing novel first-in-class or best-in-class therapies that improve patients’ lives. The patient is at the heart of everything we do.
The Clinical Trials Associate will provide support for the creation and maintenance of a paper and or electronic Trial Master Files (TMF) with a focus on maintaining Inspection Readiness throughout the lifecycle of a given Clinical Trial. This role plays an integral part in assuring that assigned TMFs are complete, accurate and timely.
- Support the clinical trial manager(s)
for all phases of study conduct (feasibility, start-up, maintenance and
close-out) of clinical trials.
- Assist in maintaining study status updates on a weekly basis (e.g., IRB approvals, regulatory document collection, patient enrollment, monitoring status, etc.).
- Provide regulatory agency inspection support by formatting, proof reading documents and contributing to the review of the Trial Master File.
- Assist clinical trial manager(s) with preparation, handling and distribution of Clinical trial supplies and tracking information.
- Prepare and maintain investigator information tracker for clinical trial operations.
- Assist with clinical trial protocol and clinical study report (CSR) review, and support for documentation requirements for CSR appendices
- Assist in the development of the structure of TMF and filing system and is responsible for filing and maintaining up to date study documents.
- Receipt, review, and filing of documents submitted for the TMF
- Coordinate timely resolution of document issues with the documents Authoritative Sources including Clinical Research Sites, Data Management Centers, Sponsors and other trial collaborators.
- Generate Certified Copies when applicable
- Create Metrics Reports to assist sponsors with trial oversight and demonstrate quality & completeness of the TMF as well as timely submission of TMF documents.
- Review regulatory documents to ensure completeness in accordance with sponsor requirements, ICH/GCPs, FDA Regulations, EMA, MHRA and other health authority regulations.
- Bachelor’s Degree.
- Minimum 3+ years of experience in related area.
- Familiarity with CTMF requirements and practices is required.
- Prior experience with creation and maintenance of Trial Master Files and/or Document Management is required.
- Experience with Electronic Data Management Systems (EDMS) and performing in the role of Clinical Research/Trial Associate (field or in-house) or Study Coordinator.
- Demonstrated organization skills and attention to detail.
Proficient computer skills (e.g. Microsoft Word,
Excel, and PowerPoint) required.
What we look
for in our people:
- Highly motivated self-starter with an entrepreneurial spirit and commitment to personal and career development.
- Desire to work in a quickly changing and fast-paced growing business.
- Unrelenting dedication to delivering results and a desire to shape the strategic goals of the business. Willing to roll up your sleeves to get the job done.
- Ability to overcome ambiguity and challenge the status quo
- Manage multiple programs with competing and aggressive time lines, prioritize activities, and work independently.
- Excellent written and oral communication skills;
experienced presenter of key messages to broad audiences including Senior