Clinical Trial Documentation Specialist
Proclinical is currently recruiting for a Clinical Trial Documentation Specialist with a biotechnology company located in Boston, MA.
- Conducts quality checks of the Clinical TMF documents.
- Work with internal functional area document owners and CRO to remediate any issues identified with Clinical TMF documents during quality check.
- Scans, files and maintains study documentation in the Clinical Trial Master Files and in the electronic Trial Master Files system and/or applicable Records Management system.
- Provides central support for uploading clinical TMF documents to EDMS to support key trial activities (e.g., regulatory submissions, clinical study reports etc.).
- Work with GDO stakeholders to review and manage operational clinical trial data to ensure quality and completeness per data quality standards and specified system guidelines.
- Provide centralized data entry support for operational systems ensuring alignment with data quality standards.
- Review operational data to inform and document trends and risk areas to key stakeholders
- Support other trial related operational activities as needed and assigned.
Skills and Requirements:
- 1-3 years of industry or comparable experience; candidates with some clinical research educational courses
- Knowledge of regulatory and Good Clinical Practice (GCP) requirements preferred
- Understanding of the Trial Master File including understanding of the DIA TMF Reference Model preferred;
- Experience working in electronic Trial Master File specifically Veeva Vault eTMF platform preferred
- Proficiency with MS Office Applications, SharePoint, Visio, etc
If you are having difficulty in applying or if you have any questions, please contact Brianna Copeland at 617-830-7546.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.