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Brief Position Description:
The Clinical Contracts Specialist (CC Specialist)/ Senior Clinical Contracts Specialist (SCC Specialist) is responsible for the timely development of investigator grants and Clinical Trial Agreement templates during the start-up stage of a Clinical Trial. The CC Specialist/ SCC Specialist will work closely with Project Management, Clinical Operations, Legal teams, and the client to ensure finalisation of approved site budgets and execution of approved site Clinical Trial Agreements.
The ideal candidate will be professional, analytical and possess excellent written and verbal communication skills.
Contracts
- *Understand which Clinical Trial Agreement template is used by countries in Novotech geographies; and where site specific templates are applicable.
- *Independent review and amendment of Clinical Trial Agreements within agreed negotiation parameters and policies.
- *Escalate Clinical Trial Agreements outside of agreed negotiation parameters and policies as required; and obtain guidance and approval by Legal for any deviations.
- *Work closely with Project Management, Clinical Services, Finance and Legal teams to facilitate timely execution of site Clinical Trial Agreement.
- *Serve as country point person for their country/region regarding Clinical Trial Agreements.
Budgets
- *Develop the investigator grant (country master budget) using industry standard systems.
- *Review the study protocol to ensure protocol assessments are included and consult with Clinical Services Team to confirm completeness of the budget.
- *Ensure industry standard of care concepts are incorporated into the budget and in line with Fair Market Value.
- *Escalate site budgets outside of agreed negotiation parameters as required and obtain guidance and approval by client for any deviations.
- *Any other tasks as assigned by Line Manager.
[근무부서 및 직급/직책]
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Minimum Qualifications & Experience: - *Bachelor’s Degree in a relevant field (science, law or other).
- *Minimum 3 years’ experience in the clinical trials industry including experience in contract and budget negotiation.
- *Understanding of business/financial concepts used in clinical trials.
- *Excellent communication and interpersonal skills. Good organisational skills; positive team player; attention to detail.
[자격요건] 경력사항: 경력(3년 이상 )
학력사항: 대학교(4년)졸업
[우대사항] 전공계열: 의/약학계열/법무
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