Highlights:

Skills:

Manager, Quality Control - Clinical Data Management 08/2006 - current
Inventiv Health Clinical, Mumbai, MAHARASHTRA India
Industry: Contract Research Organization
Ensuring that all project-related data management and quality control tasks are completed in accordance with organizational standard practices from commencement to closure of a project. Worked on various therapeutic areas such as Oncology, Rheumatoid Arthritis, Osteoarthritis, Cardiovascular- hypertension, Dermatology, Hyperlipidemia, Asthma, Epilepsy, Ophthalmology, Immunogenicity Vaccine, Diabetes, Parkinson's Disease, Epilepsy. Managed Phase I to Phase IV trials.
? Lead multiple projects and co-ordinate project work for more than 100 studies. ? Complete regular quality checks of study-specific documentation; perform rolling, interim and final QC inspections of the study databases. ? Ensure the achievement of key milestones relating to the function, such as completion of tasks towards study start-up and final database. ? Review/develop study related plans and other guidelines/documents. ? Develop and maintain communication with colleagues in other departments. ? Ensure documentation for the trial in accordance to GCP and client Standard Operation Procedures (SOPs). ? Track project progress; identify project issues and alert Senior Department Management with a view to remedial action. ? Support the development of corrective action plans. ? Mentor/support staff and project team. ? Develop CRFs/eCRFs, prepare edit/validation checks to be programmed for the project ? Perform database UAT & validation procedure UAT ? Perform data review and query generation, review of external data reconciliation and SAE reconciliation Other Activities: ? Train and guide New Associates, especially on DM and QC standards ? Oversee development of direct reports by setting goals, conducting performance reviews, evaluating and monitoring training needs, creating development plans, mentoring, and coaching ? Liaise with Quality Assurance with respect to documentation of study specific deviations. ? Identify and quantify resource requirements and projections. ? Manage billable and non-billable time for the assigned group. ? Interview, hire, onboard and train new staff as appropriate. ? Provide input to RFPs--

University of Mumbai 06/2004 - 03/2006
MUMBAI, MAHARASHTRA, India
Degree: Bachelor's Degree
Major:Business Managment
Bachelor Degree of Commerce in Business Management

Sakshi Sarmalkar Clinical Data Management