• Serve as Data Operations Coordinator or Data Team Lead.
• Perform comprehensive data management tasks including data review, writing and resolving data clarifications.
• Perform database designer activities for technologies not requiring extensive programming.
• Perform comprehensive quality control procedures.
• Independently bring project solutions to the CDM team.
• Solve issues through using the global issue escalation/communication plan.
• Consult with Standards Group for process issues; communicate ideas for process improvement.
• Assist in developing and implementing new technology.
• Understand and comply with core operating procedures and working instructions.
• Meet objectives as assigned.
• Develop and maintain good communications and working relationships with CDM team.
• Interact with CDM team members to negotiate timelines and responsibilities.
All responsibilities are essential job functions unless noted as nonessential (N).
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
• Good understanding of clinical drug development process.
• Background in medical terminology, Pharmacology, Anatomy, and Physiology.
• Excellent organizational, communication, and data management skills (detailed oriented).
• Ability to establish and maintain effective working relationships with coworkers, managers and clients
Note: This job description may be filled by the following data management roles (including but not limited to):
• Data Operations Coordinator (DOC)
• Clinical Data Coordinator (CDC)
• Lead Coder
• Coding Reviewer
• Technical Designer (TD)
• Validation Team Lead (VTL)
• Validation Team Member (VTM)
• Data Administrator (DA)
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
• Bachelor’s degree, or educational equivalence, in clinical, biological, or mathematical sciences or related field or nursing qualification with 1 year clinical trials experience in function similar to DM; or equivalent combination of education, training and experience
Bengaluru / Bangalore
3 - 6 years
CLINICAL DATA COORDINATOR, Data Operations Coordinator (DOC), CDM, Lead Coder, Coder, Coding Reviewer , Technical Designer (TD) , Validation Team Lead (VTL) , Validation Team Member (VTM) , Data Administrator (DA), clinical trials
Medical Coder,Clinical Research Associate/Manager,Other Pharma - CLINICAL DATA COORDINATOR
Serve as Data Operations Coordinator (DOC) for one or two global studies with fewer than 10 operations staff (excludes DE), or serve in a leadership role to a specific DM Task.