Clinical Data Manager

4/2012 – 12/2017

Responsibilities as Team Co-ordinator
▪ Able to handle conference calls and team meetings.
▪ Aware of process SOPs and SWIs.
▪ Have good knowledge of applications used within the process, e.g. Rave.
▪ Ability to do people management role.
▪ Performing Operational QC as required.
▪ Handling the team in absence of Team Lead.
▪ Guiding the DMs to perform their assigned tasks.
▪ Maintaining 80%:20% ratio with respect to working hands on studies with additional responsibilities.
▪ Helping Team Lead in identifying Data Manager requiring help within the team.
▪ Identifying and developing action plan in coordination with the Team Lead for Data Managers not meeting the client SLAs.
▪ Coordinating between the Data Manager and the Team Lead for all calls with the study team.
▪ Identifying areas of concern within the team and train people as and when required.
▪ Attended training on six sigma and applied six sigma knowledge for SAE email alerts in RAVE. Created slide deck for SAE email alert process and received certification for same.
▪ Involved in process improvement and organizational activities such as FMEA.
▪ Received awards for several categories such as Opel, Spotlight, and Wikipedia for the outstanding work and innovative ideas been delivered at Cognizant level.

Responsibilities as Clinical Data Manager
▪ Lead Data Manager for several studies.
▪ Point of contact for clinical data management activities for internal project team and client.
▪ Managed time effectively to produce quality deliverables in expected project timelines.
▪ Worked as Team Coordinator with responsibilities such managing team in absence of Team Lead, prioritizing and assigning work to team members, mentoring and guiding members in team etc.
▪ Executing data management activities such as data cleaning, executing manual and system edit checks, update relevant tracker, discrepancy management, query management, issue resolution, database lock activities, SAE reconciliation and external data reconciliation.
▪ Reviewing and taking action on queries on an ongoing basis.
▪ Experienced in Set-Up, Migration, Conduct, Interim and Database Lock activities of studies. Completed 3 Study Setup, 10 migrations, 2 Publish Edit checks, 6 Interim database lock and 2 final database lock for different therapeutic area studies.
▪ Communicating with client through mails and teleconference.
▪ Following up with Clinical Trail Team for various issues and study activities.
▪ Managing and tracking of reports like page status report, clarification tracker, study status report, missing pages report etc.
▪ Cleaning of data by data review methods and locking of subjects. Performing ongoing and final consistency checks, review protocol deviation and data listings as defined in the DMP and eCRF Review Manual.
▪ Sending mails to study team for follow up or updates.
▪ Creating study set up documents like Requirements document, e-CRF completion guidelines, Data validation plan, Data management plan, Data review plan.
▪ Experience in creating edit checks and test script creation for User Acceptance Testing. Performing UAT according to Data validation plan for applicable Data Management systems.
▪ Perform SAE reconciliation, IVRS Reconciliation and External data reconciliation. Performing SAE Reconciliation between the Safety and Clinical study databases with supporting documentation. Issuing queries for data points that exhibit unacceptable discrepancies as appropriate.
▪ Being compliant with all the procedures and SOPs and SWIs.
▪ Ensure that all Data Management activities are conducted in compliance with relevant regulatory requirements.
▪ Participating in the QC activities (Peer QC) for the junior data managers who are in on job training or mentoring phase.
▪ Worked on applications like J-Review and HP-ALM.
▪ Good in Microsoft Excel, Word and Power point.

Klinische Forschung