Shravani kanduri

• Collaborates with the TMF Inspection Readiness Specialist to plan and execute assigned tasks.
• Maintains an 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 feedback to PS/FL superusers in CRS technology in order to enable enhanced systems, tools, and processes.
• Maintains the TMF for ongoing studies according to Parexel SOP's or contractual obligations to sponsor, by performing completeness checks/Milestone reviews or other TMF contracted tasks according to the established timelines and quality criteria.
• Proactively cooperate with LM and FLs on the project's TMF tasks.
• Understands how their own role and expertise impact TMF quality and timeliness.
• Takes proactive measures to prepare a study for audit.
• Facilitates internal and external TMF Audits.
• Collaborate with the study team and manage TMF tools customizations 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 SOP's.

• Complete required trainings according to required timelines.
• Complete day-to-day tasks ensuring quality and productivity.
• Assist in tracking and follow-up of action items. Maintain project and technical documentation in an appropriate manner.
• Perform checks to ensure quality of work completed Maintain Quality control procedures, including periodic basic quality, Inventory and completeness checks to ensure accurate maintenance of files.
• Ensure timely escalation as needed. To acquire knowledge and skills to process study documents in accordance with client and study requirements as per study-specific processes, where applicable.
• Assist in the document receipt and processing which may include document receipt and review, scanning and indexing, quality control, copying, filing, forwarding or return to client/study teams and archiving for all documents in the scope of agreed processes/activities or within the scope of GSDM throughout the study duration.
• To participate in client audits as necessary Assist the study start up teams with tasks required for site start up activities.
• Other duties/activities as assigned by study management team, but not limited to:

1) Manage study documents such as study level, country level and site level.

2)Maintain study databases (CTMS)

3)Support study team in e-TMF management activities.