When our values align, there's no limit to what we can achieve.
Primary Duties:
General
1. Managescountrydeliverables,timelines,andresultsforassignedprotocolstomeetcountrycommitmentsincluding:
2. Quality and compliance in assigned protocols in country
3. Coordinates and liaises with Clinical Research Managers(CRMs), Clinical Research Associates (CRAs) and Clinical Trial Coordinators (CTCs),Finance and Legal ifappropriate toensure country deliverablesare obtained for submissions, budgets, CTRAs and local milestones
4. Collaborates closely with Headquarter to align country timelines for assigned protocols
5. Provides support and oversight to local vendors as applicable
6. Oversees CTCs as applicable
7. Contributes to thedevelopment of local SOPs
8. Oversees and coordinates local processes,clinical and ancillary supplies, import and export requirements, supplies destruction, local electronic/hard copy filing, archiving and retention requirements, and insurance process management
9. Enters and updates country information in clinical and finance systems
10. Contributesor leadsinitiatives and projects adding value to the business
11. Contributes strongly to the COM team and other Country Operations roles knowledge by acting as process Subject Matter Expert (SME), sharing best practices, making recommendations for continuousimprovement,and providing training as appropriate/required
12. Contributes to COM teamand other Country Operations roles’knowledge by acting asa buddy/mentor and as a process Subject matter Expert (SME),sharing best practices, making recommendations for continuousimprovement,and providing trainingas appropriate/required
13. Completestraining assigned by Client and/or EP, as necessary, including general training requirements, SOPs, and system and process related training
14. Adheresto EP and Client SOPs and processes
Finance:
15. Has ownership of country and site budgetsincluding:
16. Development, negotiation, and completion of Clinical Trial Research Agreements (CTRA)
17. Oversight and tracking of clinical research‐related payments
18. Payment reconciliation at study close‐out
19. Oversight of Foreign Corrupt Practices Act (FCPA), Denied Party Screening/Office of Foreign Assets Control (DPS/OFAC)and maintenance of financial systems
20. Financial forecasting in conjunction with SCOM,CRDand other roles
21. Influences investigators, external partners, and countryoperations to adhere to budget targets and agreedpayment timelines.
Regulatory:
22. Executes and oversees clinical trial country submissions and approvals for assigned protocolsincluding:
23. Development of local language materials including local language Informed Consents and translations
24. Interactions with IRB/IEC and Regulatory Authority for assigned protocols
Skillsand Education:
25. Bachelor's Degreein Business Finance/ Administration/ Life Science or equivalentHealth Care related experience required
26. 5‐7 years clinical research or combined experience in Clinical Research and Finance/Businessrequired
27. Expertise of core clinical systems, tools, and metrics
28. Excellentverbal and written influencing and training/mentoring skills, in local language and English
29. Strong coordination and organizational skills
30. Skilled knowledge of budget and contract negotiations, local regulatory environment and submission and approval processes, and understanding of how theseimpactstudy start-up
31. Able to indirectly influence investigators, vendors, external partners, and country managers to address and resolve issues, with minimal support from theSCOM or manager.
32. Ability to make decisions independently with limited oversightfrom SCOM or manager
33. Requires a strong understanding of local regulatory environment
34. Ability to proactively develop risk managementand mitigation plans in the country and resolve issues locally
35. Ability to lead a team of CTCs as applicable
36. Problem solving is essential
37. Ability to proactivelyidentifyissues and risks,analyze root cause and propose solutionsand escalate as applicable
38. Effective and efficient time management, organizational and interpersonalskills,and conflict management skills
39. High sense of accountability and urgencytoprioritize deliverables
40. Expertise of core clinical, regulatory, and financial systems, tools,andmetrics,
41. Strong communication, leadership, and negotiation skills as well as excellent influencing and training/mentoring skills
42. Ability to focus on multiple deliverables and protocols simultaneously
43. Requires that the individual has ability to work effectively also in a remotevirtualenvironment with a wide range of people
44. Positive mindset, growth mindset, capable of working independently and self - driven
45. Ability to directly influence site staff