Assistant Clinical Data Manager
Quintiles (NYSE: Q) is the world’s largest provider of biopharmaceutical development and commercial outsourcing services with a network of more than 29,000 employees conducting business in approximately 100 countries. We helped develop or commercialize all of 2013’s top-100 best-selling drugs on the market.
Quintiles applies the breadth and depth of our service offerings along with extensive therapeutic, scientific and analytics expertise to help our customers navigate an increasingly complex healthcare environment as they seek to improve efficiency and effectiveness in the delivery of better healthcare outcomes. To learn more about Quintiles, please visit www.quintiles.com
Provide 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), the role of the Data Team Lead (DTL) or in a leadership role in a specific DM task (e.g. lead of a task on a megatrial, coder, database designer for technologies that don’t require extensive programming expertise).
- Serve as Data Team Lead (DTL) on multiple global studies.
- Provide leadership to DM team.
- Manage DM customer relationship for DM project team including active participation in DM customer negotiation on timeline, budgetary and other issues (with guidance).
- Provide marketing capabilities presentations and business development presentations.
- Or serve as Data Operations Coordinator (DOC) for one or two global studies with fewer than 20 operations staff (excludes DE), or serve in a leadership role to a specific DM Task.
- With minimal guidance, serve as back-up for Data Operations Coordinator or Data Team Lead, providing leadership and technical expertise to Operations team.
- Manage delivery of projects through full data management process life-cycle.
- With minimal guidance, manage project timelines and quality issues, determine resource needs, and identify and justify out-of-scope.
- Provide input for negotiations with customer.
- Provide comprehensive data management expertise (including all operations tasks and DMP generation).
- Perform database designer activities for technologies not requiring extensive programming.
- Perform comprehensive quality control procedures.
- Independently bring project solutions to the CDM team.
- Solves 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
- Thorough knowledge of the data management process
- Knowledge of Medical Terminology, Pharmacology, Anatomy, and Physiology
- Previous experience and proven competence in managing delivery of project through full data management study life-cycle (of several large phase I or at least 1 medium size Phase III)
- Comprehensive understanding of clinical drug development process
- Excellent organizational, communication, and data management skills (detail oriented)
- Ability to establish and maintain effective working relationships with coworkers, managers and clients
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
- Bachelor’s degree, or educational equivalent, in clinical, biological or mathematical sciences, or related field, or nursing qualification with 3 years of related experience including clinical trials experience in a function similar to DM; or equivalent combination of education, training and experience
- 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
Back to top