The Clinical Contracts Specialist (CC 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 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.
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.
Responsibilities : 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.
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. 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 in clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities.
We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to contacting you regarding your application.
About Us
Novotech is a global full-service clinical Contract Research Organization (CRO).
Headquartered in Sydney, Australia, Novotech has 34 offices across Asia-Pacific, North America, and Europe. Novotech employs over 3000 employees and has over 5000 site partnerships and the resources and infrastructure to scale regionally and globally as clinical programs advance.
Novotech provides clinical development services across all clinical trial phases and therapeutic areas including feasibility assessments, ethics committee and regulatory submissions, data management, statistical analysis, medical monitoring, safety solutions, central lab services, report write-up to ICH requirements, project and vendor management. Novotech obtained the ISO 27001 certification which is the best-known standard in the ISO family providing requirements for an Information Security Management System. Together with the ISO 9001 Quality Management system, Novotech aims at the highest IT security and quality standards for patients and biotechnology companies.
About the Team
At Novotech we have advanced therapeutic and regulatory expertise, the ability to execute across markets and a client-centric service model, so that our clients get a trusted, long-term partner and an accelerated path to bring their life-changing advances to market. This gives our employees the opportunity to develop their careers by joining a diverse and supportive global organization with a collaborative culture, whilst working with clients on the cutting-edge of life sciences.
* Strategic vs transactional mindset.
* Ability to gain insights and make proactive decisions quickly.
* Culture that fosters partnership and collaboration, where every voice is heard and valued.
* Ongoing support from senior stakeholders and leadership team.
Job Info
* Job Identification 3165
* Posting Date 04 / 07 / 2025, 10 : 34 AM
* Job Schedule Full time
* Locations 27F Podium West Tower, The Podium, ADB Avenue, Manila, 1550, PH
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