Mumbai Maharashtra, India
Phone: xxx-xxx-xxxx
Email: xxx@xxxx.xxx
Looking For: clinical data manager, clinical research coordinator
Occupation: Life, Physical, and Social science
Degree: Bachelor's Degree
Career Level: Experienced
Languages: English, Hindi, Marathi
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