TMF Inspection Readiness Specialist [Romania]

 

The Trial Master File Inspection Readiness Specialist (TMF IR Specialist) acts as a steward for the TMF and has advanced knowledge on Parexel or Sponsor specific Electronic Trial Master File (eTMF) and paper documents management processes and procedures.

In this role, you will be a primary Point of Contact for the study TMF, ensuring the ability to coordinate study TMF activities with a high degree of proficiency, focusing on TMF Inspection Readiness. You will work with all relevant stakeholders, providing TMF expertise and facilitating adequate oversight.

Key Accountabilities

Start-up

• Participates in study kick-off meeting and drives discussions regarding design of TMF plan.
• Provides recommendations in terms of and client expectations for TMF, including budget and resources implications.
• Works with the PL to set realistic client expectations and enable client TMF oversight.

Process and project management

• Coordinates TMF milestones to the established timelines and quality criteria.
• Provides input to relevant project guidelines as required and proactively flags potential project risks in terms of TMF deliverables and provides feedback to project team and client to design solutions.
• Leads or participates in internal monthly TMF review meetings.
• Recognizes out of scope activities and communicates to responsible Project or Functional Leader.
• Assesses required resources against study Quality Control (QC) plan / study TMF milestones, study budget/hours and other key factors directly impacting TMF QC plan / milestone reviews, where applicable.

TMF Quality Management

• Monitors and evaluates TMF Inspection Readiness status, employing available tools and metrics, escalating concerns and proposing action items to the study team if needed
• Maintains the TMF for ongoing studies according to Parexel SOP’s or contractual obligation to sponsor.

TMF Audit Management and TMF Archival Preparation

• Takes proactive measures to prepare studies for audit and inspection preparation and attends audits and inspections as TMF representative.
• Collaborates with Project Leader and the other Functional Leads to confirm TMF activities are completed at study close out as required by Sponsor and Parexel procedures.

Competencies, skills and abilities:

• Good computer skills including but not limited to the knowledge of Clinical Trial Systems, eTMF systems and MS-Office products such as Excel, Word

Data processing and analysis skills, including TMF metrics design and understanding all aspects of the project lifecycle

• Ability to create a sense of urgency and take a proactive, solutions-based approach
• Proficient and proactive risk management and problem-solving abilities
• Excellent written and verbal communication with internal and external stakeholders
• Strong command of written and spoken English language
• Strong Client focus for both internal and external customers; willing to attend and anticipate client needs Offering of support and constructive feedback to project team members

Education:

Bachelor’s degree preferred or relevant clinical or business equivalent.

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