Clinical Systems Manager

Position Summary:

The Clinical Systems Manager for Trial Master File (TMF) System is responsible for overseeing a team of Documents Specialists collecting, reviewing, maintaining, and archiving essential clinical study documents for the Trial Master File (TMF) in accordance with Good Clinical Practice (GCP), E6 ICH Guidelines and other regulatory guidance documents, relevant regulations (e.g., 21 CFR Parts 312 and 314, EMA Clinical Trials Directives), and Precision Standard Operating Procedures (SOPs) as appropriate. The Clinical Systems Manager, TMF will provide oversight, support and back up the Document Specialists on one or more clinical programs. The Manager is also responsible for monitoring the performance of the system; documenting training, performance and enhancements; and ensuring overall completeness and inspection ready status of study eTMFs.

Essential functions of the job include but are not limited to: 

Oversight & Quality (60%)

• Ensure proper development of TMF plans for clinical studies
• Oversee the quality of TMF support provided by Documents Specialists to clinical teams
• Complete periodic and random quality and completeness checks of work performed by Documents Specialists
• Review TMF metrics via system reports and dashboards, and identify process and performance challenges
• Identify systemic issues with quality and completeness of TMF and recommend solutions
• Train Documents Specialists in the performance of TMF responsibilities

Staff Management (20%)

• Perform weekly or biweekly 1:1 meetings with team members to discuss workload, responsibilities, performance, and related topics
• Perform semi-annual and annual performance reviews, providing clear and direct feedback to promote performance excellence
• Ensure staff development and training
• Review and interview candidates, and make hiring decisions for new Documents Specialists
• Ensure the team is fully staffed and able to support the requirements of clinical documents management in the TMF

Document Management (10%)

• Perform the responsibilities of a Documents Specialist as required to backfill staff as needed and to support overflow work

Qualifications:

Minimum Required:

• 4-year college degree or equivalent combination of education and experience in information systems or technology
• Minimum of 7 years’ TMF and/or eTMF experience
• Minimum 3 years of line management experience or demonstrated skills and experience

Other Required:

• Established experience and fluency in the Microsoft Office package of programs (Outlook, Word, Excel and PowerPoint)
• Ability to speak English proficiently (professional level)

Competencies:

• Demonstrates, or able to train and retain, a working knowledge of ICH-GCP, and relevant Precision SOPs and regulatory guidance
• Demonstrates solid interpersonal skills
• Exhibits strong self-motivation, is detail-oriented and able to work and plan independently as well as in a team environment
• Demonstrates professionalism, as evidenced by punctuality, ability to deliver on commitments, possess good interpersonal skills and maintain positive interactions with internal and external stakeholders
• Communicates both verbally and in written form in an efficient and professional manner
• Demonstrates values and a work ethic consistent with Precision Values and Company Principles

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Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. © 2020 Precision Medicine Group, LLC

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