Job Description

India, Remote
Job ID R0000017927 Category Clinical Trials

ABOUT THIS ROLE

• Collaborates with the TMF Inspection Readiness Specialist to plan and execute assigned tasks.
• Maintains overview of the agreed planning, proactively providing status updates and notifying trends to the study team and TMF IR Specialist.
• Stays flexible and always looks for proactive, responsible solutions to ensure client satisfaction.
• Provides feed-back to PS/FL Super Users in CRS Technology in order to enable enhanced systems, tools and processes.

• Maintains the TMF for ongoing studies according to PAREXEL SOP\xe2\x80\x99s or contractual obligation to sponsor, by performing completeness checks/ milestone reviews or other TMF contracted tasks according to the established timelines and quality criteria.
• Proactively cooperates with LM and FLs on project\xe2\x80\x99s TMF tasks.
• Understands how their own role and expertise impact TMF quality and timeliness.

• Takes proactive measures to prepare study for audit.
• Facilitates internal and external TMF audits.

• Collaborate with the study team and manages TMF tools customization and TMF Plan / CFMP Development and sign off.

• Participates in the TMF closure process as required by Sponsor and PAREXEL Procedures.
• Prepares eCRF CDs and participates in eCRF process as defined in the relevant manuals and SOPs

• 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 (\xe2\x80\x9cvirtual\xe2\x80\x9d) 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 work

• 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 language

• Bachelor\xe2\x80\x99s degree preferred (or relevant clinical or business equivalent)