Serve as main point of contact for Data Management for 5 to 10 studies, or serve in a leadership role to a specific DM Task.
Manage delivery of projects through full eCOA data management study life-cycle.
Manage eCOA DM project timelines and quality; determine resource needs; identify out-of-scope work.
Perform comprehensive data management tasks including data review, writing and resolving data clarifications.
Provide support in database design activities for technologies not requiring extensive programming.
Perform comprehensive quality control procedures.
Independently bring project solutions to the eCOA team.
Solve issues through using the global issue escalation/communication plan.
Consult with eCOA ops 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 eCOA team.
Interact with other study team members to negotiate timelines and responsibilities.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
Good understanding of clinical drug development process and Data Management activities.
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.
Ability to work within a team and with a good level of autonomy.
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
Bachelor s degree, or educational equivalence, in clinical, biological, or mathematical sciences or related field or nursing qualification with 2-4 year clinical trials experience in function similar to DM; or equivalent combination of education, training and experience.
PHYSICAL REQUIREMENTS
Extensive use of telephone and face-to-face communication requiring accurate perception of speech
Extensive use of keyboard requiring repetitive motion of fingers
Regular sitting for extended periods of time

Clinical Data Specialist

Job Description

Required Skills