Scope: Strategic Planning | New Initiatives | Capability Building | Global Data Management | Clinical Operations | Process Management | Team ManagementI have primarily focused on management of Clinical Trial Data Manager team and in assigning trials during all phases of the trial like start-up, conduct and closure phases in Biopharm project area. My forte has been in hosting and contributing to share best practice discussions within project team and data management as well as in… Show more Scope: Strategic Planning | New Initiatives | Capability Building | Global Data Management | Clinical Operations | Process Management | Team ManagementI have primarily focused on management of Clinical Trial Data Manager team and in assigning trials during all phases of the trial like start-up, conduct and closure phases in Biopharm project area. My forte has been in hosting and contributing to share best practice discussions within project team and data management as well as in ensuring proper coordination with clinical operations & resource allocation on the assigned trials from data management in a timely manner. I have involved in strategic discussions and implementing an enhanced and empowered global data management roles in the unit with close collaboration with global data management unit.I focus on successful and sustainable data management deliverables in close collaboration with Biostat, Clinical operations and other functional partners. Not only this, I also invest in develop, coach, empower and support the team individuals; thereby achieve higher levels of professional competency for current and future roles and responsibilities. Focused on the team self-sustainability, empowering the individuals to their potential with connection to the organization needs and developed to take up leadership role. Show less

Primarily focused on: Leading and driving the team on DM deliverables during start-up, conducting and closing phases of projects for a key portfolio (phase 2 to 4) and key project, large and complex trials. Successful and sustainable DM deliverables in close collaboration with stakeholders, skill areas, and project areas,  Driving global process improvements, simplifying and streamlining processes and driving department initiatives. Ensuring a continuous improvement mind-set… Show more Primarily focused on: Leading and driving the team on DM deliverables during start-up, conducting and closing phases of projects for a key portfolio (phase 2 to 4) and key project, large and complex trials. Successful and sustainable DM deliverables in close collaboration with stakeholders, skill areas, and project areas,  Driving global process improvements, simplifying and streamlining processes and driving department initiatives. Ensuring a continuous improvement mind-set by participating in quality activities, feedback sessions and lessons learned. Show less

I contributed in Ph2-4 trial deliverables of CDM in a key project area and transitioned from other DM units. Developed the capability of therapy knowledge of the team, understand the requirements and deliver high quality clinical data for timely regulatory submissions My forte was in promoting the exchange of know-how within the Data Management area and externally via participation in relevant national and international societies.

Over here, I managed an entire site in Chennai for major pharmaceutical client. I have contributed in identifying talents, building their competencies and managing high quality deliverables in a short duration. Demonstrated excellence in managing an entire site in Chennai and built the team to full capacity of 70 professionals, 5 Therapy areas, Managers & Specialist, managing their development needs, streamline the processes, coordinating with stakeholders. Worked closely with the onshore… Show more Over here, I managed an entire site in Chennai for major pharmaceutical client. I have contributed in identifying talents, building their competencies and managing high quality deliverables in a short duration. Demonstrated excellence in managing an entire site in Chennai and built the team to full capacity of 70 professionals, 5 Therapy areas, Managers & Specialist, managing their development needs, streamline the processes, coordinating with stakeholders. Worked closely with the onshore therapy area managers for the delivery of high-quality validated data. I adroitly managed Study Design Team, Study build quality and Quality control team – which focused on designing the database and study and created mock CRFs, built the screens, created the DVS (Data Validation Specification) and the final CRFs for the study and the quality team to perform the QC of the study build team activities like edit checks programming etc..and the Quality control team ensures compliance of the training requirements as per client need. Show less

I acted as a Process owner for ‘Clinical Data Loading & Issue resolution’ for a big pharma client, Transitioned from US. Substantially handled a high priority Phase IV infectious Disease study. Involved in a process improvement initiative and implemented the new process of handling of lab data loading and issues resolution for all the studies across therapy areas. Along with this handled other Infectious Disease and Inflammation Studies for data management deliverables.

CDM Training (6 weeks) | Area of Work: Women’s health and Infectious Diseases studies.