Manish Rane

As a TA Lead -

• Managing Portfolio of Medical Affairs INDIA studies
• Provide technical expertise to Clinical Data Management team. Act as a ‘Mentor' for the Lead Data Managers (LDMs) and Data Managers
• Ensure all client requirements are completely understood and met for quality deliverable by Clinical Data Management Team
• Providing inputs to CDM work instruction and SOPs
• Organize Knowledge sharing sessions with Lead Data Managers and Feedback sessions for team in coordination with CDM Team Leads
• Proactive identification and implementation of opportunities for process improvement at organization level.
• Provide inputs to Lead data manager and Group Leads for resource planning, project management and forecasting.
• Participate in important study meetings like Study Kick-off Call, Pre-milestone discussions, Escalation calls etc.
• Complete team member's periodic appraisal cycles and evaluations on time

As a Lead Data Manager -

• Acts as a Single Point of Contact and managing all the activities right from study set up to archival for the assigned studies
• Maintains full understanding of protocol including study documentation
• Performed assigned tasks independently and within timelines according to the CDM Project Plan, SOPs and Sponsor specific requirements
• Preparation and Maintenance of Quality Control Responsible for attaining all requirements from the client for quality deliverable
• Creation and Maintenance of Study Project Plan
• Review of all the study set up documents like eCRF specification, Validation specification, Third party agreements, Data Management plan, eCRF completion guideline etc for the assigned studies
• Review of all the study conduct activities like Metrics, Discrepancy Management, Reconciliation activities, SAS listing review, SDTM exception report etc.
• Ensure all the Study Close out activities are performed and completed as per the study close out plan
• Regularly liaises with monitoring, database programming, medical coding and statistical programming teams to ensure smooth functioning of a study.
• Hands-on production work along with Clinical Data Managers as and when need arises
• Perform QC of activities completed by Data Manager as per the Quality Control Plan
• Lead the important study meetings like Weekly connect with client,Study Kick-off Call, Pre-milestone discussions, Escalation calls etc.

• Leading the studies for the assigned project from study set up to close out
• Creation of all the study documents for the set up, conduct and close out activities
• Handling of study activities for study set up, conduct and close out phase
• Regularly liaises with monitoring, database programming, medical coding and statistical programming teams to ensure smooth functioning of a study
• Liaises with clients and produces trial progress reports
• Performs other miscellaneous activities along with QC of database, processes and documentation, as required.

Reviews and processes clinical trial data to ensure the accuracy and consistency of clinical databases. Commonly performs the following data related activities: CRF tracking, CRF/eCRF review, validation and updating clinical data. Provides accurate, timely, and consistent clinical data to both sponsors and other internal departments to support the business needs of Kendle.

To perform Pharmaceutical based Clinical Data Management & Laboratory Clinical Data Management activities. To deliver an error free patient data in accordance with the clinical data management project plan and US Food & Drug Administration regulatory standards.

Enrollment and Screening activity

Study Day and Follow up Activity