Senior Clinical Trial Associate

About Dermavant

Dermavant Sciences is a biopharmaceutical company committed to fostering unprecedented change and unparalleled impact in immuno-dermatology.

Our mission is to make healthier skin a reality for the millions of people around the world living with chronic skin conditions.

That's why we're hard at work developing novel treatments that deliver groundbreaking science exactly where patients need it - their skin.

Because skin is more than superficial - it's where we live, every moment of every day.

It also brings great culture. Dermavant Sciences has been independently named by both the Los Angeles Business Journal and Fortune Magazine as a Best Place to Work three years running.

For more information about Dermavant, check out our Glassdoor page or visit us on LinkedIn and Twitter.

With 150+ years of combined dermatology expertise from the Dermavant leadership team working towards our goal of transforming lives, the future at Dermavant is bright.

We are excited for you to see what's next!

Position

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.

Responsibilities

• 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.

Qualifications

• Bachelor's Degree.
• Minimum 3+ years of experience as a CTA in the Pharmaceutical, Biotechnology, or Contract Research Industry.
• 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 timelines, prioritize activities, and work independently
• Excellent written and oral communication skills; experienced presenter of key messages to broad audiences including Senior Stakeholders

As an equal opportunity employer, Dermavant is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state and local laws.

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