Perform complex processes and tasks that eventually result in high quality deliverable that are completed according to service level agreements (SLAs) and within project timelines.Establish and maintain effective project/ site communications.Create and maintain relevant project documents.Ensure accurate completion and maintenance of internal systems, databases, tracking tools, timelines and project plans with project specific information.Participate in document management (creation, review, maintenance, storage, as applicable).Provide support & mentor/training to coworkers within RIM.Serve as TMF contact for documentation to Project team, cross functional departments to ensure high quality TMF deliverables are met on time.Follow processes for set up, maintenance, and support for assigned TMF projects.Facilitate collecting, processing and disposition of various project-related records for paper & electronic documents to sponsor.Follow applicable SOP’s to ensure completeness & accuracy of eTMF.Prepare/present TMF related information at internal meetings in a globally consistent format.Provide support & involvement with internal quality or audit processes as relevantAccountable for delivery of assigned TMF activities in accordance with project requirements & SLA’s.Manage documentation associated with assigned clinical trials.Follow records management tasks, policies, and procedures.Conduct review documents with compliance to IQVIA or customer file plans and SOPsSME on all designated Sponsor-specific TMF requirements (e.g. file format, process, and export/shipping requirements).Provide regular updates on performance to SLAs.Running system reports-CTMS, IXRS, EDC(Inform and Rave)Performing QC in CTMS against IXRS/EDC for the payment batch approval.Checking incomplete/ missing page, query aging and follow-up with CRAs, LCA and CL for resolution. Review of PD against protocol guidance document.

Identifying/selecting an investigator who will be responsible for the conduct of the trial at the trial site.Liaising with doctors/consultants or investigators on conducting the trial.Setting up the trial sites, which includes ensuring each centre has the trial materials, including the trial drug often known as the investigational medicinal product. Training the study staff in standard operating procedure for the clinical trials as per applicable regulatory requirements.Verify that investigator and investigator’s team are adequately trained and comply with the protocol.Verify that IRB/IEC operates and complies as per GCP, SOP and applicable regulatory requirements.Monitoring the trial throughout specified duration involving monitoring visit to the trial sites.Source data verificationInformed consent form review, case report form review, investigational drug accountability, and adverse event review.Ensuring all unused trial supplies are accounted for.Writing visit reports, filing and collecting trial documentation and reports.

Identifying and briefing appropriate trial investigators (clinicians).setting up and disbanding trial study centers.designing trial materials and supplying study centers with sufficient quantities.providing clinicians with instructions on how to conduct the trialscollecting and authenticating data collection forms (commonly known as case report forms)monitoring progress throughout the duration of the trialIdentifying/selecting an investigator who will be responsible for the conduct of the trial at the trial site.Liaising with doctors/consultants or investigators on conducting the trial.Setting up the trial sites, which includes ensuring each centre has the trial materials, including the trial drug often known as the investigational medicinal product. Training the study staff in standard operating procedure for the clinical trials as per applicable regulatory requirements.Verify that investigator and investigator’s team are adequately trained and comply with the protocol.Verify that IRB/IEC operates and complies as per GCP, SOP and applicable regulatory requirements.Monitoring the trial throughout specified duration involving monitoring visit to the trial sites.Source data verificationInformed consent form review, case report form review, investigation drug accountability, and adverse event review.Ensuring all unused trial supplies are accounted for.Writing visit reports, filing and collecting trial documentation and reports.

• Site Feasibilities.• Management of Ethics Committee submission on clinical study.• Scheduling patient visits as per protocol schedule of events. • To maintain the essential documents at the site.• To maintain and submit the progress status of the trials to the Ethics Committee.• Assisting for Regulatory Affairs department.• To maintain and submit revisions & amendments of trials related documents to Ethics Committee.• To maintain & document relevant communications with Sponsors/CRO i.e. meeting notes, letters and telephone calls.