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.

Job Responsibilities:

• 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 n.patel@proclinical.com.

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.

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