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Clinical Contract Specialist

2 months ago


Kuala Lumpur, Malaysia Novotech Asia Full time

**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.

**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.
- Good knowledge of legal and medical terminology.
- Understanding of business/financial concepts used in clinical trials.
- Excellent communication and interpersonal skills. Good organisational skills; positive team player; attention to detail.

**Responsibilities**:

- 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 and site budgets within agreed negotiation parameters and policies.
- Escalate Clinical Trial Agreements, site budgets outside of agreed negotiation parameters and policies as required and obtain guidance and approval by Legal for any deviations.
- Serve as key communication liaison between Sponsor and Novotech.
- Work closely with Project Management, Clinical Services, Finance and Legal to facilitate timely execution of site Clinical Trial Agreement.
- Develop the investigator grant (country master budget) using industry standard systems and provide country budget to local team for negotiation with sites.

Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect.

Our team members are passionate about what we do, but we understand work is only of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs.

We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities.


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