4 Senior Clinical Trial Associate Jobs in Morrisville, NC
Dermavant Sciences is Hiring a Senior Clinical Trial Associate Near Morrisville, NC
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!
PositionThe 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.
- 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.
- 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
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Job Summary
Full Time
Scientific Services
$67k-88k (estimate)
06/21/2024
07/18/2024
dermavant.com
LONG BEACH, CA
50 - 100
2016
MICHAEL ADASCZIK
<$5M
Scientific Services
Related Companies
The job skills required for Senior Clinical Trial Associate include Clinical Research, Clinical Trial, Leadership, Career Development, Biotechnology, Dedication, etc. Having related job skills and expertise will give you an advantage when applying to be a Senior Clinical Trial Associate. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Senior Clinical Trial Associate. Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for Senior Clinical Trial Associate positions, which can be used as a reference in future career path planning. As a Senior Clinical Trial Associate, it can be promoted into senior positions as a Scientist - Clinical Research that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Senior Clinical Trial Associate. You can explore the career advancement for a Senior Clinical Trial Associate below and select your interested title to get hiring information.
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