Trial Master File Inspection Readiness Specialist

At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Parexel offers an exciting opportunity to take a step into the world of Clinical Research by joining our Trial Master File (TMF) Management Team as a TMF Inspection Readiness Specialist.

TMF Inspection 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. Represents a primary Point of Contact for the study TMF and assumes the ability to coordinate study TMF activities with a high degree of proficiency, focusing on TMF Inspection Readiness.

This role can be office-based in Bucharest or decentralised from Romania.

Key Accountabilities:

- 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.

- Provides TMF expertise to manage client concerns in terms of TMF. Identifies inconsistencies and inefficiencies in processes and recommends solutions as well as out of scope activities and communicates to responsible Project or Functional Leader.

- Monitors and evaluates TMF Inspection Readiness status, employ available tools and metrics, escalate concerns and propose action items to the study team if needed.

- Maintains the TMF for ongoing studies according to Parexel SOP’s or contractual obligation to Sponsors.

- Checks/ milestone reviews or other TMF contracted tasks according to the established timelines and quality criteria.

Attends audits and inspections as TMF representative.

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.

- 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.

- Ability to work independently with oversight guidance.

- Strong Client focus for both internal and external customers.

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.