Labcorp is transforming how patients are diagnosed, monitored, and treated.
Are you looking for a new start within a clinical document environment? Interested in working alongside Data Management & Biometrics teams in an administrative & IT-focused opportunity?
Perhaps you have some experience within a medical/life sciences environment but now looking to be home-based and have the opportunity to work closely alongside a wide range of teams, involved in the clinical trial process.
Labcorp is seeking a Clinical Document Specialist to join the global Clinical Pharmacology Services Team. The position can be full-time based in Leeds, or can be home-office based, within the UK.
Your main responsibilities will include but not be restricted to:
- Responsible for general maintenance and any required archival of documents produced by the study project teams within CPS.
- 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 Labcorp 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 Study Project Manager (PM) 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.
- Performs archiving duties for all paper and/or electronic media, as needed.
- Maintains departmental files including, but not limited to, project files.
- Any experience within an administrative or IT-focused role within clinical trials or a hospital/medical setting would be advantageous. Full training will be provided.
- Experience working with computers and basic programs (i.e., Adobe Acrobat, Word, Excel, PowerPoint).
Education / Qualifications
- 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.
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