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| Job Location | Chennai |
| Education | Not Mentioned |
| Salary | Not Disclosed |
| Industry | Pharma / Biotech |
| Functional Area | Sales / BD |
| EmploymentType | Full-time |
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.QualificationsCompetencies, 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 management of TMF documents as per the process using different systems/tools for TMF Audit/Inspection readiness Ensure effective, open, timely, and collaborative written and verbal communication, with internal and on occasion external stakeholders Ability to successfully work in a ( virtual ) team environment: In-depth understanding of how the team integrates with others in accomplishing the objectives of the area Able to demonstrate basic problem solving and risk management activities Effective time management, prioritizing multiple tasks in order to meet daily metrics, team and project objectives Proactive management of work quality and the assurance of consistent delivery of high-quality outcomes, minimizing wasted effort and maximizing positive results from performed work Able to take initiative and work independently, seeking guidance only when necessary and escalating issues as required Strong internal customer focus Offering of support and constructive feedback to project team members Exhibits a sense of urgency about solving problems and completing workKnowledge and Experience: Preferred experience with clinical trials, or managing documentation Good understanding of procedures and concepts within own technical/subject area and a proficient knowledge in other related areas. Prior experience in an international environment would be advisable. Strong command of written and spoken English languageEducation: Bachelor s degree preferred (or relevant clinical or business equivalent),
Keyskills :
ms officerisk managementdata processingcomputer skillsproblem solvingclinical trialstime managementverbal communicationconstructive feedbackinternational environment