Clinical Document Specialist

3 months ago

Leeds, United Kingdom Fortrea Full time

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.

Fortrea 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 Fortrea 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.

Experience
- 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.

Keywords:
Fortrea, Phases I-IIa, CRO, Contract Research Organisation, Contract Research Organization, pharma, pharmaceutical, clinical data management, early phase, early development, clinical data, home based, pharma, home-based, flexible working, flexible location, field based, field-based, United Kingdom, UK, Leeds, Home-office based, #LI-Remote, Remote, EMEA

Fortrea is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

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