Trial Master File Manager job in Cambridge, USA

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Last Name*

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First Name*

Last Name*

Email*

Phone Number*

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Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

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Phone Number*

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Are you an employer or a jobseeker?*

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Job type: Contract

Discipline: Program Manager / Director, Clinical Scientist, Clinical Outsourcing

Location: United States

This vacancy has now expired. Please see similar roles below...

Proclinical is seeking to hire a Trial Master File Manager located in Cambridge, MA.

Job Responsibilities:

Create and manage Study TMF Filing plan with input from Study team
Provide day to day document management support
Support TMF review process by working closely with study teams, CROs and Vendors
Ensure Study EDLs and Milestones are configured and maintained
Perform and manage TMF Quality reviews and drive for constant inspection readiness of TMFs
Serve as point of contact and support study teams for resolution of TMF-related queries or quality issues
Act as point of contact to support TMF audits and inspections as required
Support and/or deliver training across company, CRO, and Vendors on the policies and procedures relative to and for TMF management
Foster positive relationships with external vendors and internal clinical development areas

Skills and Requirements:

6-9 years as TMF manager with prior Veeva eTMF Specialist experience
Strong working knowledge of the TMF Reference Model
Strong knowledge of Good Clinical Practices (GCP), regulations/guidelines and of the auditing process and compliance requirements in relation to TMF
Experience of electronic document management system(s) and Veeva Etmf
Working knowledge of Regulatory Agency Audits and NDA/MAA Submission triggered Inspections preferred
Strong interpersonal skills and ability to manage at all levels within a cross-functional organization through influence
Continuous improvement mindset and ability to function independently with a proactive, self-starter attitude
Proficient in common office technology e.g. Microsoft tools, teleconferencing, etc.
Ability to handle a high volume of complex tasks within a given timeline
eTMF Administration
- Act as Subject Matter Expert for eTMF management
- Oversee the management of askTMF mailbox and FAQ log

If you are having difficulty in applying or if you have any questions, please contact Kate Heffernan at (+1) 610-624-3327 or K.Heffernan@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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