Provide solid core and some comprehensive data management expertise to Data Management to provide efficient, quality data management products that meet customer needs.
Provide leadership either in the role of the Data Operations Coordinator (DOC), or in a leadership role in a specific DM task (e.
g. lead of a task on a megatrial, coder, and database designer for technologies that don't require extensive programming expertise).
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.
Manage delivery of projects through full data management study life-cycle.
Manage project timelines and quality; determine resource needs; identify out-of-scope work.
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.
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)
Technical Designer (TD)
Validation Team Lead (VTL)
Validation Team Member (VTM)
Data Administrator (DA)
EEO Minorities / Females / Protected Veterans / Disabled