Associate Clinical Data Manager/Clinical Data Specialist

RESPONSIBILITIES

• Provide comprehensive data management expertise to Clinical Data Management (CDM) 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 CDM task (e.g. lead of a task on a megatrial coder tester database designer for technologies that dont require extensive programming expertise).

• Serve as Lead on multiple global clinical trials or 35 increasingly complex central laboratory studies.

• Provide leadership to CDM and Operations team.

• Manage CDM customer relationship for CDM 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 clinical trials with fewer than 20 operations staff (excludes DE) or 20-30 central laboratory studies or serve in a leadership role to a specific data management task.

• Provide specific CDM task or technology expertise.

• 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 creation of project specifications).

• 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 and project teams.

• Interact with CDM team members to negotiate timelines and responsibilities.

REQUIRED KNOWLEDGE SKILLS AND ABILITIES

• Thorough knowledge of the data management process and experience in specialized data management skills (e.g. therapeutic extensive knowledge SAE reconciliation central laboratory and/or new technology

• Knowledge of operating procedures and work instructions and the ability to apply them in practice

• Excellent experience and organizational communication and demonstrated expert data management skills

• Comprehensive understanding of clinical drug development process (detail oriented)

• Ability to establish and maintain effective working relationships with co-workers managers and clients

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

• Bachelors degree or educational equivalence in clinical biological or mathematical sciences or related field or nursing qualification with 2 - 3 years related experience in a function similar to data management: or equivalent combination of education training and experience

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