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Summary of Key Responsibilities
1. Manage integration of project team activities, leveraging internal and external resources, expertise and knowledge, along with optimizing CRO resources, expertise and knowledge.
2. Provide input on trial level operational strategies for clinical trials from protocol design to the final clinical study report for specified studies
3. Provide input into global subject/patient recruitment plans.
4. Relationship management between study sites and vendors
5. Manage aspects of CRO/vendor identification and the day to day operational management activities of CROs & other vendors including set up, statement of work creation and budget oversight.
6. Manage strategic study operations including: study sites and tracking systems for regulatory submissions, drug supply and use, enrollment of subjects, regulatory document flow, study timelines, all budgetary and financial information, performance metrics, data flow, etc.
7. Create and update critical trial-specific documents (for example country specific ICF) and plans
8. Support development of compound and protocol level training materials
9. Review and provide input into budgets, timelines, and forecasts for assigned clinical studies
10. Interface with internal key stakeholders including, but not limited to; Finance, Program Management, Vendor Management, Safety, Accounting, Clinical Supply, Quality Assurance, Data Management, Statistics, Clinical Research, Commercial, Regulatory, Bio Analytical, Medical Affairs; which may include acting as a liaison between groups.
11. Provide support for inspection readiness activities and on identification of risks and mitigation plans at the trial level
12. Participate in process improvement activities at a trial and department level as needed
13. Support onboarding of new team members
14. Attend CTWG and provide input and updates on operational activities and progress
15. Ability to travel (approximately10% but flexibility to go over or below as per business need.
Qualifications
16. BS/ BA Degree is required.
17. 5+ years of clinical research experience gained with a CRO, Biotech, or Pharmaceutical Company working on Phase 1-4 global clinical trials.
18. 2-3+ years leading aspects of global clinical trials
19. Experience working with a CRO
20. Strong regulatory knowledge, including Good Clinical Practices (GCPs)
21. Strong decision-making, analytical and financial management skills are essential to this position
22. Proven ability to foster team productivity and cohesiveness and the ability to operate and execute with limited supervision
23. Experience in leading without authority and in multifunctional matrixed and global environments
24. Experience mentoring/ coaching others
25. Exceptional organizational skills and ability to deal with competing priorities, also strong reasoning and problem-solving ability.
26. Strong project planning/ management, communication (written and verbal) and presentation skills
27. Experience with protocol, ICF, CRF, CSR development and review.
28. Proficient with MS Office Suite (Excel, Word and PowerPoint)