Associate Clinical Data Manager/clinical Data Specialist

1 week ago

Bloemfontein, South Africa IQVIA Full time

**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 don’t 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 mínimal 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**:

- **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**
- **Bachelor’s 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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