Job Description

A TMF (Trial Master File) Inspection Readiness 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. The TMF IR Specialist represents a primary Point of Contact for the study TMF.
The TMF IR Specialist assumes the ability to coordinate study TMF activities with a high degree of proficiency, focusing on TMF Inspection Readiness. Achieves department's overall business objectives and works with all relevant stakeholders, providing TMF expertise and facilitating adequate oversight.

Key Accountabilities:
TMF Set 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 in collaboration with the TMF reviewer and/or other TMF contracted tasks according to the established timelines and quality criteria.
- Provides input to relevant project guidelines as required.
- 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, regularly providing TMF status updates.
- Provides TMF expertise to manage client concerns in terms of TMF.
- Identifies inconsistencies and inefficiencies in processes and recommends solutions.
- Recognizes out of scope activities and communicates to responsible Project or Functional Leader.
- Assesses required resources against study QC plan / study TMF milestones, study budget/hours and other key factors directly impacting TMF QC plan / milestone reviews, where applicable.
- Provides feed-back to PS/FL Super Users in CRS Technology in order to enable enhanced systems, tools and processes.
- Maintains proactive communication and collaboration with Clients.
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; if required may perform completeness checks/ milestone reviews or other TMF contracted tasks according to the established timelines and quality criteria.
TMF Audit Management:
- Takes proactive measures to prepare studies for audit and inspection preparation.
- Attends audits and inspections as TMF representative.
Training and Exposure:
- Fully able to deliver training and mentoring for junior team members.
- Identifies best practices developed during project and shares lessons learned across the organization or at project level, as applicable.
- Proactively flags re-training needs for study team on general or study specific TMF requirements.





Qualifications

Skills and Competencies:
• 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
• A flexible attitude with respect to assignments and new learning
• Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail, while also maintaining high level oversight
• Excellent written and verbal communication with internal and external stakeholders
• Advanced ownership and assurance of consistent delivery of high-quality outcomes, minimizing wasted effort and maximizing positive results from performed work
• Ability to work independently with oversight guidance
• 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.

Knowledge and Experience:
• Proven relevant TMF management experience and proficient / advanced level of required competencies.
• Excellent understanding of procedures and concepts within own technical/subject area and a proficient knowledge in other related areas.
• Strong command of written and spoken English language.

Education:
• Bachelor's degree preferred or relevant clinical or business equivalent.




Why Work at Parexel

There are pivotal moments in every career: Sharing new treatments. Improving processes. Delivering life-saving advances. The people who succeed are the ones who make the journey go further and faster every time. What if you had a partner to support you as you reach the next level in your professional path? A partner who believes a collaborative environment is key to achieving your goals? A partner who is dedicated to your health and wellness so you can help make a difference in the lives of millions worldwide?

That's Parexel. We're a diverse team of professionals focused on one goal: getting treatments into the hands of those who need them most. Working together, the results we bring to our clients and the opportunities we bring to our team get better with every step.

How can we help you on your journey? Find your path, and learn more on LinkedIn, YouTube, Facebook, Twitter, and Glassdoor.