• Aug 2020 - Present

DM service provision across India, China, Australia and USA | BD | DM Revenue Management| Vendor Management | Collaborations | Team Building | Leadership

• Sep 2019 - Jul 2020

End to end DM service provision for GC India

• Feb 2019 - Sep 2019

• Mar 2016 - Feb 2019

LEADERSHIP> Provide expertise, leadership and administrative management for data management staff in George Clinical, India, focusing on training and career development> Developing and maintaining of data management SOPs and quality systems> Resource planning and coordination to meet the DM needs of the local and global clients> Liaison with relevant stakeholders to plan and track work for current and proposed projects> Mentor, train and supervise DM staff across GC locationsDATA MANAGEMENT> Ensure delivery of data management services for commercial and academic studies within pre-specified agreed targets and timelines> Financial management of DM activities, tracking budget against ongoing study activities, costs and charges> Providing oversight and coordination of DM activities and other research projectsQUALITY/PROCESS IMPROVEMENT> Ensure quality control of all relevant processes and activities performed> Report and escalate identified issues in areas of responsibility according to George Clinical and/or project requirements> Oversee compiance with all applicable regulations, guidelines, SOPs and project-specific requirementsBUSINESS/CUSTOMER FOCUS> Build strategic collaborations, partnerships and teams > Preparation and input into RFPs, and development of DM costing estimates for new local and/or global projects> Participate in the bid defence process and be the contact person for DM > Be the DM system vendor contact person and manage contracts> Liaise with the customer (external and internal) to determine study requirements in the ongoing studies Show less

• Jul 2015 - Mar 2016

Key responsibilities were:> Protocol review and feedback> Monitoring timelines and study progress, milestones by participating in the discussions with the clients right from KOM till DBL> Supervising and monitoring staff workload and identifying resource issues> Performing staff reviews in consultation with the Data Team Manager> Providing ad hoc guidance and assistance to clinical team (CRAs/Clinical Project Managers) to meet milestones> Monitoring adherence to guidelines and policies> Review of Database build progress and QC and validation including Database Specifications, Edit Check Specifications, Data Export/Import Definitions> Review and assessment of mid study updates > Review of various DM documents (DMP, CRF, NTF, MedDRA and WHO-DD coding guidelines)> Review Medical Coding (Adverse Events, Medical History, Medications)> Training of clinical data managers, data associates, and data assistants in DM concepts> Improvement of efficiency by maintaining and improving quality systems> Liaison with other clinical services groups (QA, Stats, Clinical)> Assisting Data Team Manager in monitoring budget and finance Show less

• Jul 2011 - Jun 2015

Key responsibilities were:> Review study protocols, and autonomously manage data projects> Manage staff members to complete projects> Data entry for clinical studies in accordance ICH-GCP requirements> Perform AE (MedDRA) and medication (WHO-DD) coding> Develop Case Report Forms conforming to the database and protocol> Design databases and ensure they meet the requirements for data entry and supervisory role with expanded management responsibility> Assist specialist-Biostatistician/Pharmacokineticist in PK analysis and QC PK related Tables/Listings/Figures> Preparation and/or review of all data related documents> Active involvement in continuous improvement of the quality systems> QC of sections of clinical study reports (CSR) related to data conclusions Show less

• Mar 2007 - Jul 2011

Key responsibilities were:> To act as clinical data coordinator for allocated projects & coordinate data activities> To develop CRFs in line with the database and protocol> Designing databases in DMSys and Clintrial and expanded supervisory role> Expanded Management role within data team > Preparation of data management plans with minimal supervision> Assisting expert Pharmacokineticist in PK analysis, and PK related Tables, Figures & listing preparation> Performing internal review of data related documents & SOPs> MedDRA coding with minimal supervision Show less

Clinical Data Coordinator

• Jun 2006 - Mar 2007

> Data entry > Data review, QC, query management > Lab data and CRF data tracking > AE coding > Data entry > Data review, QC, query management > Lab data and CRF data tracking > AE coding

• 2003 - 2006

Worked on the project 'Blood Rheology' (Hemorheology). Research objective: To study the viscosity changes in human blood and erythrocyte deformation and aggregation- Project included experiments with human whole blood and RBCs using Rheometer and Laser Assisted Optical Rotational Cell Analyser (LORCA). - Travelled to University of Akdeniz, Antalya, Turkey for 3 months to perform experiments on red blood cell deformability and aggregation.- Presented posters in APSA conferences (Sydney 2003 and Adelaide 2006, Australia) and International conference on Clinical Hemorheology (Chongqing, China 2005)- International Conference on Medical Diagnostic Techniques & Procedures, IIT Madras (Chennai 2004, India) Show less

• Jul 2004 - Oct 2004

Asst Manager

• May 2000 - Jul 2001

Worked in the department of Quality Control and Formulation development Key responsibilities inculded: - QC of raw materials and In process QC - Assisting the process of development of new dosage forms - Preparation of master formula and batch formula records - Coordination between departments such as Production, QA, Packaging, and QC Worked in the department of Quality Control and Formulation development Key responsibilities inculded: - QC of raw materials and In process QC - Assisting the process of development of new dosage forms - Preparation of master formula and batch formula records - Coordination between departments such as Production, QA, Packaging, and QC

Lecturer

• 1999 - 1999

Teaching Anatomy, Physiology and Basic Pharmacology to students of Diploma in Pharmacy Teaching Anatomy, Physiology and Basic Pharmacology to students of Diploma in Pharmacy