Clinical Contract Specialist - Europe at Novotech Global

Belgrade, Central Serbia, Serbia -

Full Time

Start Date

Immediate

Expiry Date

26 Aug, 26

Salary

0.0

Posted On

28 May, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Contract Negotiation, Budget Development, Clinical Trial Agreements, Financial Analysis, Stakeholder Management, Legal Terminology, Medical Terminology, Microsoft Excel, Project Management, Risk Analysis, Quality Control, Interpersonal Communication

Industry

Biotechnology Research

Description

About The Role: The Clinical Contracts Specialist (CC Specialist) is responsible for the timely development of country budgets and Clinical Trial Agreement templates during the start-up stage of a Clinical Trial. The CC Specialist will work closely with Project Management, Regulatory & Start-Up, Clinical Operations, Finance, Legal teams, and the client to ensure finalization 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 in multiple countries. * Good knowledge of legal and medical terminology. * Understanding of business/financial concepts used in clinical trials. * Excellent communication and interpersonal skills. Good organizational skills; positive team player; attention to detail. * Proven ability to collaborate effectively with internal stakeholders (Clinical operations, legal, finance, procurement) and external stakeholders (Clients and Sites). * High level of attention to detail with the ability to manage multiple contracts and competing deadlines in a fast-paced environment. * Experience in managing Business acumen  * Proficiency in Microsoft Office (especially in Excel) * Ability to work collaboratively or individually in a fast-paced and deadline-driven environment. 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. * Serve as key communication liaison between Sponsor and Novotech. * Manage assigned workload to deliver contract review at agreed service levels. * Work closely with local team, Project Management, Clinical Services, Finance and Legal teams to facilitate timely execution of site Clinical Trial Agreement. * Guides local team during the negotiation cycle to facilitate timely execution. * Support preparation and finalization of ancillary agreements as needed. * Facilitate the execution of contracts by company signatories. * Track executed contracts in appropriate system and collect relevant metrics. * Review and analyze any risk to Novotech and escalate to legal counsel, as necessary. * Serve as country point person for their country/region regarding Clinical Trial Agreements. Budgets * Review and QC of 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. * If required, obtain client review/approval of country budget. * Provide country budget to local team for negotiation with sites. * Independent review and amendment of site budgets within agreed negotiation parameters. * Escalate site budgets outside of agreed negotiation parameters as required and obtain guidance and approval by client for any deviations. * Work closely with local team, Project Management and Clinical Operations to facilitate timely finalization of site budgets. * Guides local team during the negotiation cycle to facilitate timely approval. * Track finalised budgets in appropriate system and collect relevant metrics. * Serve as country contact point person for their country/region regarding investigator grants. * 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, 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. We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to contacting you regarding your application. Novotech is a global full-service clinical Contract Research Organization (CRO). At Novotech, ambition meets opportunity. As a globally recognized leader in clinical research and scientific advisory services, we are proud to combine our position at the forefront of the industry with an award-winning workplace culture that values ambition, innovation, and growth. Named Employer of Choice, Great Place to Work and Employer of Choice for Gender Equality (EOCGE), we are committed to fostering an environment that reflects the life-changing work we do. Since 1997, we have expanded our global footprint, now with 30+ offices across Asia-Pacific, the United States, and Europe. This growing network unites professionals from diverse backgrounds and disciplines to advance therapies that improve patient outcomes worldwide. At Novotech, our employees are at the heart of our success. By offering trust, flexibility, and autonomy through programs like NovoLife, our flexible benefits framework, we empower team members to create an effective work-life balance that delivers professional satisfaction and maximum results for clients. With access to mentorship opportunities, professional development programs, and a dynamic community, Novotech offers a platform for driven individuals to achieve personal growth while shaping the future of healthcare. Join us to be a part of a team that values your contributions and supports your ambition to make a global impact. 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. At Novotech you will work alongside empowered teams with a shared commitment to success. * 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. .

Responsibilities

Responsible for developing country budgets and Clinical Trial Agreement templates during the start-up phase of clinical trials. Collaborates with legal, finance, and clinical operations teams to ensure the timely execution of site agreements and budgets.