Manager, Clinical Data Management
Job Code: CSA0511B
Southborough, MA
Description:
MANAGER, CLINICAL DATA MANAGEMENT Manages Clinical Data Management
activities to ensure the successful completion of projects and achievement
of departmental goals. Provides technical guidance to the data management
staff, prioritizes responsibilities and supervises employee development.
Serves as a primary resource and point of contact for departmental staff,
project managers, line managers, executive staff and clients.
Requirements:
Bachelor’s or Master’s degree; minimum 5 years of clinical data
management experience including a minimum of 3 years project or team
management experience within the industry; at least 1 year management within
a CRO. Must have the ability to manage the company’s clinical data
management operations. Must have a thorough understanding of: the clinical
research development process; Good Clinical Practices and ICH guidelines;
the clinical data management process; physiology, pharmacology, clinical
study objectives and methodologies. Must have excellent verbal and written
communications skills, problem-solving skills; very good computer skills;
strong understanding of database design, CRF design techniques. Must have
experience: leading and managing large scale projects and staff; preparing
and managing project budgets and timelines. Must have strong:
organizational, leadership, decision making skills.
Preferred Qualifications:
Master's degree or advanced coursework in the life sciences; 5+ years
experience in clinical data management including 2 years in a CRO
environment; 3 years management experience including some training
experience.
- Ability to perform overnight business travel on annualized average
of 70-75% overnight travel
- Home based CRA’s must have a minimum of 6 months home office
experience
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