Study Management Specialist needed for a contract opportunity with Yoh Scientific’s client located in Wilmington, DE area.
This position is in the Clinical Trials department of a major pharmaceutical company, and requires a Bachelor’s degree and 3-5 years of experience with clinical trials document management.
- Set-up the local Trial Master File (eTMF) and Investigator Site File including tracking of documents. Maintain and close the local TMF (in electronic or paper form depending on study) ensuring International Conference of Harmonisation Guidelines for Good Clinical Practice (ICH/GCP) compliance and local requirements. Support the CRA in the maintenance and close out activities for the ISF.
- Contribute to the production and maintenance of study documents, ensuring template and version compliance.
- Create and/or import clinical-regulatory documents into the Global Electronic Library (GEL) according to the Global Document List (GDL)
- Handle clinical-regulatory documents according to the requested technical standards i.e. Submission Ready Standards (SRS), supporting effective publishing and delivery to regulatory authorities (not for international studies).
- Set-up, populate and accurately maintain information in tracking and communication tools (e.g. IMPACT, SharePoint etc) and support others in the usage of these systems
- Bachelor’s degree is preferred
- 3-5 years of experience in clinical trial document management and regulatory documents is required
- Veeva experience a plus
- Accountable and inquisitive; thinks "outside the box"
- Must be methodical, compliant to processes yet flexible when needed
- Independent yet able to work cohesively with a team
- Candidates must be local to Wilmington, DE; non-remote position
Opportunity is Calling, Apply Now!
Recruiter: Mary Nestojko, Mary.Nestojko@yoh.com
What’s In It For You?
We welcome you to be a part of one of the largest global staffing companies to meet your career aspirations. Yoh’s network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh’s extensive talent community that will provide you with access to Yoh’s vast network of opportunities and gain access to this exclusive opportunity available to you.
- Medical, Dental & Vision Benefits
- 401K Retirement Saving Plan
- Life & Disability Insurance
- Direct Deposit & weekly ePayroll
- Employee Discount Programs
- Referral Bonus Programs
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