RESPONSIBILITIES
1. Serve as primary point of contact for customer on data management deliverables
2. Manage multiple large studies or program of studies (possibly global)
3. Provide leadership and senior support to DTLs on multiple large global programs of global studies
4. Provide project management expertise working with customer data managers, key decision makers, and internal team members to manage continuous process improvements, issue escalation, workload projections, and provide technical expertise
5. Lead direct negotiations with customer, e.g., timelines, financial, process, resources
6. Meet with Data Operations team members on a regular basis to ensure milestones meet timelines and quality deliverables
7. Independently manage DM service delivery with comprehensive DM process and technical expertise in executing projects
8. Serve as the escalation point for unresolved data issues
9. Ensure appropriate resources are assigned to meet project deliverables
10. Create and/or review and sign-off on all data management plan (DMP) documents
11. Manage service performance and provide leadership to identify root causes of issues and implement remedial actions
12. Serve as Subject Matter Expert (SME)
13. Provide leadership and expertise in a specific CDM task or technology
14. Independently manage SOW/budget
15. Independently bring process improvements and solutions to the CDM team/CDM department
16. Lead a focus team or global or local best practice team
17. Provide review and expert opinion in developing, revising, and maintaining core operating procedures and work instructions
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
18. Previous experience and proven competence in managing delivery of multiple global trials through full DM life-cycle (i.e. large trials of at least 1000 patients)
19. Demonstrated expert data management skills and advanced knowledge of the data management process (e.g., therapeutic area, extensive knowledge in DM processes, SAE reconciliation, external data vendor reconciliation)
20. Previous experience and proven competence in handling complex customer negotiations and bid defense meetings independently
21. Knowledge of Medical Terminology, Pharmacology, Anatomy, and/or Physiology
22. Knowledge of operating procedures and work instructions and the ability to apply them in practice
23. Knowledge of Good Clinical Practices and relevant regulatory guidelines
24. Excellent communication, interpersonal, customer service, and teamwork skills
25. Excellent organizational and problem-solving skills
26. Excellent project management skills
27. Ability to work independently
28. Comprehensive understanding of clinical drug development process
29. Ability to establish and maintain effective working relationships with co-workers, managers and customers
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
30. Bachelor’s Degree, or educational equivalent, in health, clinical, biological or mathematical sciences, or related field
31. Around 7 years direct Data Management experience, including 5 or more years as a CDM project lead; or equivalent combination of education, training and experience
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