inVentiv Health Data Management QC specialist | PUNE/MUMBAI in Mumbai, India
Organization Overview inVentiv Health Clinical is a leading provider of global drug development services to pharmaceutical, biotechnology, generic drug, and medical device companies. With 6,500 passionate employees supporting clients in more than 70 countries, inVentiv Health Clinical works to accelerate high quality drug development programs of all sizes around the world. Like you, we are committed to enriching the lives of patients, families, and communities by helping to expedite the quality delivery of our clients’ therapies to market.
Title Data Management QC specialist | PUNE/MUMBAI
Job ID 13864
Responsibilities • Assist in the preparation of Quality Control Plans.
• Assist in monitoring compliance with SOPs, Policies and Operating Guides related to data management
• May attend project team meetings regarding quality control activities.
• Complete regular quality checks of study-specific documentation from study startup till archival
• Perform rolling, interim and final quality control inspections of the Clinical Study Database.
• Perform the Data Management Quality Control activities for Interactive Response Technologies (IRT) processes and data for client projects and IRT platform.
• Coordinate the work of associates for assigned projects.
• May train personnel on project-specific quality requirements.
• Coordinate activities conducted by others in the department.
• Prepare documentation of quality control findings.
• May assist in preparation for sponsor or regulatory audits.
• May support the development of corrective action plans.
• May assist in completing quality control checks of Computer System Validation (CSV) documentation.
• May collect and maintain project metrics.
Responsible for performing activities that are in compliance with applicable Corporate and Divisional Policies, Standard Operating Procedures and Operating Guidelines and performing other duties as assigned by management.
Note: This job description describes the principal and main elements of the job. It is a guide to the nature and main duties of the job as they currently exist, but is not intended as a wholly comprehensive or permanent representation.
Requirements • Three (3) years of work experience in clinical research, drug development, data management, or other healthcare environment, with at least two (2) years of direct Data Management and one (1) year of process Quality Control experience
• Demonstrated interest in quality
• Familiarity with medical terminology
• Excellent communication, interpersonal skills, both written and spoken,
City Mumbai / Pune
Country India [IN]