Amit Bhowmick Email & Phone Number

Bengaluru, Karnataka, India

Bengaluru, Karnataka, India

Below are some responsibilities of my job role:• Managing a team of professional Data Management staff i.e Lead data managers, data managers.• Identified as SME for internal process and contribute to process improvements and automations.• Responsible for attaining all client requirements for quality deliverable.• Participates in internal planning and strategies ensuring constant support to clients need.• Provide expert review and guidance for production of data management deliverables including eCRF, database design and set-up, validation definition and programming, data management plan and database deliverables to internal and external customers.• Ensure that staff is trained and compliant with current operating procedures and work instructions and project scope of work.• Identify and address professional development/training needs of staff.• Mentor staff members to develop Data management process, system, and drug development expertise.• Understand scope of work, budget, and scope assumptions.• Ensure project milestones are met according to agree upon timelines.• Utilization of appropriate data management tools to monitor quality and timeliness data flow for assigned sites.• Responsible for work allocation to the team and tracking the status.• Responsibilities include planning, assigning, directing work, appraising performance, and guiding professional development• Addressing employee relations issues and resolving problems.

Below are some responsibilities of my job role:• Maintains full understanding of protocol including study documentation.• Preparation and maintenance of Quality Control Plan.• Responsible for attaining all client requirements for quality deliverable.• Reviewing and finalizing eCRF completion guideline.• Reviewing DVR and eCRF specifications.• Reviewing UAT plan, UAT performance and UAT report.• Review and maintenance of DMP metrics.• Escalate any discrepancy in the clinical data to TA lead and client as appropriate.• Hands-on production work along with Clinical Data Management as and when need arises.• Perform sample size Quality check on the queries.• Utilization of appropriate data management tools to monitor quality and timeliness data flow for assigned sites.• Responsible for work allocation to the team and tracking the status.• Monitor and review manpower utilization.• Co-ordinate and plan for the project deliverables.• Ensure that the team members meet all agreed upon SLAs (Quality, Productivity and Turnaround time)• Prepare for audit and ensure the audit readiness among the team members.• Proactively identify and implement opportunities for process improvement and takes accountability for implementing the same.

Bangalore

Below are some responsibilities of my job role: • Create Data management plans;• Case report form design and quality control review;• Database design and testing;• Edit checks, and the validation of these;• Coding of data using standard coding dictionaries, where applicable;• User Acceptance Testing as and when required;• Data handling reports;• Data cleaning, including manual review, reconciliation and query generation and resolution;• Preparation and maintenance of all data management documentation, including reports, governing data management processes, as and when required.• Ensure that service and quality meet specifications delineated in Procedural Documents, data management plan and scope of work.• Assist the Senior/Lead Data Manger with delegated tasks and responsibilities, including but not limited to support in the preparation and review of Procedural Documents and the filing and maintenance of clinical trial documents in the designated sections of the Trial Master Files.• Other tasks as may be required and agreed upon.• Hosting study meetings with BIOS, coding, CRAs, vendors and sponsors on a weekly and monthly basis.• Preparing Study status reports, clean patient tracker to track study health.• Improved client consultations and determined needs through team management.• Provided excellent leadership skills to maintain steady and productive operations.• Managed team of twenty-two employees, overseeing the hiring, training, and professional growth of employees.

Bangalore

• Key responsibilities were to conduct the basic data review and cleaning activities- pulling reports, managing queries, listings, reconciliations along with support in updating the vendor issue- logs, freezing and locking activities and provide training to the new resources on some of the data management activities.• Also looked after resource management, finance management of the studies.• Handled the study communication plan from start up to close out along with different stake holders like sponsor, BIOS team, medical team, programming team, data management team and vendors.• Worked on Rave, Inform and SureSource databases.• Review of protocol and Edit check specifications to understand study design.• Involved as a trainer for new Joinees.• Handled multiple studies as DOC and back-up DTL.• Involved in communications with internal and external customers for study discussions.• Involved in process improvement and enhancement program.

Mumbai Area, India

• Key responsibilities are to conduct the basic data review and cleaning activities- queries, listings, reconciliations and training the new resources on some of the activities.• Key member to handle vendor data and create Data transfer specification document of all vendor data.• Created reports detailing findings and recommendations.• Designed and implemented key measurement reports for conveying metrics to customers, monitoring service levels and attainments, identifying trends and performing root cause analysis.

Bengaluru, Karnataka, India

-Involved in market survey.-Understanding the products and launching the drugs into the markets- pharmacies and hospitals.-Part of financial discussion and strategies to capitalize the opportunity of sales and meeting the monthly and quarterly targets.