Senior Trial Master File Specialist
Proclinical is currently recruiting for a Senior Trial File Specialist with a leading biotechnology company located in Gaithersburg, MD. As the Senior Trial Specialist, you will be responsible for the oversight, management, and quality of clinical trial content, with a strong focus on oversight of the set up and routine documentation filing of the TMF to ensure adherence with the TMF Plan, SOPs, and ICH/GCP/regulatory guidelines.
- Overall management and quality maintenance of essential clinical trial documents and other designated content, including the set up and maintenance of the TMF, with a strong focus on ensuring that routine document management operations are performed with adherence with SOPs and ICH/GCP/regulatory guidelines
- Oversight and assistance with the overall TMF completion, including appropriate content filing and maintenance, cross-functional document coordination, including third party content
- Reviews TMF Plans and timelines; interact with CRO partners to oversee their TMF activities and review and provide feedback on performance metrics
- Conducts and documents TMF/eTMF content reviews for quality, completeness, and other performance metrics on a regular basis to support inspection readiness
- Maintain metadata and indexing, processing, publishing, records retention best practices
- Work with internal functional groups to facilitate, train, and review filing of TMF content
- Manages activities for off-site archival of TMF content
- Provides input to TMF strategy including internal TMF SOPs or work instructions governing studies using an outsourcing model
- Manage and organize the clinical operations and TMF content within the network file share drive
- Verifies receipt, reviews for identification and consistency, sorts, separates, photocopies, prints, scans, indexes, labels, and files a variety of clinical, regulatory, and other non-clinical documents, as assigned
- Files content into electronic Trial Master File (eTMF) management systems such as Veeva Vault eTMF
- Other duties as assigned
Skills and Requirements:
- Bachelor's degree, preferably in a scientific discipline
- 3 5 years or more of experience with eTMF management systems, solutions, practices, workflows
- Working knowledge of Good Documentation Practices (GDP), Good Clinical Practices (GCP) and TMF best practices, such as the DIA Reference Model
- Capable of working with multiple IT systems, including Electronic Document Management Systems
- Experience with coordinating document management activities performed by internal teams and third parties, such as clinical vendors
- Ability to manage multiple projects and effectively prioritize activity
- Knowledge of clinical research concepts and able to work in a team environment
- Excellent organizational and planning skills
- Ability to build and maintain positive relationships with management and peers
- Excellent written and verbal skills required
- Good written and spoken English
- Computer literacy: e.g. Microsoft Word, Excel, PowerPoint, Outlook, Project
If you are having difficulty in applying or if you have any questions, please contact Natasha Patel at (+1) 617-778-7319 or firstname.lastname@example.org.
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.