- Experience Level
- Experienced (non-manager)
Your new employer is Covance by Labcorp , the world's most comprehensive drug development company, dedicated to advancing healthcare and delivering Solutions Made Real ® .Our unique perspectives, built from decades of scientific expertise and precision delivery of the largest volume of drug development data in the world, along with our innovative technology solutions, help our clients identify new approaches and anticipate tomorrow's challenges as they evolve.
Covance is seeking a Clinical Document Specialist to join the Clinical Pharmacology Services Team in Leeds, West Yorkshire. Your new position is a full-time and permanent position and youwill play an integral role in supporting the Project Management team.
Your main responsibilities will include but not be restricted to:
- Responsible for general maintenance and any required archival of documents produced by the CPS Project Management Team.
- Organizing, gathering, scanning, and filing of all applicable documents into appropriate electronic and/or paper copy locations, including the Trial Master File (TMF), as directed by Covance SOPs or other applicable directive.
- Responsible for document query generation and file reconciliation/resolution activities to support delivery of the TMF to client quality and integrity specifications, as well as to meet project timelines and productivity targets.
- Maintains an internal standardized filing structure for study-related documents.
- Works directly with the assigned Project Manager (PM) and Project Coordinator (PC) to review and finalize the TMF Plan and Index for individual projects.
- Creates and/or maintains any general document/file-related tracking forms and/or spreadsheets, as applicable.
- Maintains the TMF by working with applicable project team members to retrieve, file, and upload documents in accordance with applicable SOPs, policies, system, and client requirements.
- May interact directly with project teams in securing documents for the TMF, as appropriate.
- May interact directly with project teams to follow up regarding missing documents, as appropriate.
- Works with the PM/PC, involved project teams, and applicable business partners for reconciliation of the TMF as part of the quality control process.
- May generate and deliver requested CD copies for clients and archive projects.
- Performs archiving duties for all paper and/or electronic media, as needed.
- Maintains departmental files including, but not limited to, project files.
Get ready to redefine what's possible and discover your extraordinary potential at Covance by Labcorp. Here, you'll have the opportunity to personally advance healthcare and make a difference in peoples' lives with your bold ideas and unique point of view. With the support of exceptional people from across the globe and an energized purpose, you'll be empowered to own your career journey with mentoring, training and personalized development planning.
Join us as we speed the delivery of ground breaking therapies and anticipate tomorrow's drug development challenges, creating new possibilities for our clients and your career.
- High School Diploma or equivalent
- Strong written and verbal communication skills (English language).
- Strong organizational skills, with the ability to work in a fast-paced setting with many interruptions.
- Experience working with computers and basic programs (i.e., Adobe Acrobat, Word, Excel, PowerPoint).