Country Study Start-up Manager (all genders)

Work Your Magic with us!  

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.  

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

We are seeking a pioneering Country Study Start-up Manager who is passionate about driving change and leading teams toward success in clinical trials. This role requires a dynamic individual who thrives in a fast-paced environment and is committed to making a meaningful impact in the field of clinical research.

Your role

The role of the Country Study Start-up Manager is to support the following processes:

1. Submissions and Site Activation

• Responsible for timely and quality completion of clinical trial activities up to the site activation at a country/cluster level, including local/central EC/IRB submissions (incl. amendments and notifications), essential documents collection and preparation of IP release packages, vendor activities management leading to sites readiness for patients to be screened.
• Serve as site’s primary point of contact for Country Start-Up to compile (or assist sites with, as applicable) documents for submission package, to collect and execute Confidentiality Disclosure Agreements, to collect Site Feasibility Questionnaire, and to perform IRB/IEC submissions.
• Serve as site’s primary point of contact for Country Start-Up activities, to manage study amendments during the conduct phase (incl. submission, ICF...)
• Collect, review, approve, and track essential documents, and review, adapt and approve Country/Cluster Site ICFs (initial and amendments, and corresponding translations) in accordance with local requirements, processes and timelines
• Proactively identify risks or delays and develop mitigation strategies to ensure on-time site activation.
• Manage regulatory authority and EC/IRB communications until approvals are obtained.
• Inform the required Payments of EC/IRB and SSU fees to the Site and Payment Specialist
• Perform Import/Export License Application (as needed)
• Collect the site docs required for IP release, compiles the Regulatory Green Light Package (IP Package) and submit it to the reviewer.
• After Site Activation, perform the handover of the site to the Clinical Research Associate (who will be in charge of Essential Documents Collection from site), raising any relevant item or risk for follow-up.
• Forecast and track metrics and progress of Site Start-Up for assigned clinical sites, ensuring all sites are greenlight on time per Study Start-Up timelines, and report to global and regional/country/cluster stakeholders
• Maintain accurate records and documentation in applicable tracking systems and Trial Master File (TMF).
• Ensure metrics are up to date and accurate on tracking and reporting of local/central EC/IRB submission/approval progress in Clinical Trials Management System (CTMS), eTMF and other applicable systems.

2. Clinical Site Agreements

• Responsible for drafting, negotiating and executing Contracts and Budgets with trial sites, including contract and amendment language, budgets, and regulatory compliance, within the required timelines and as per negotiation guidance.
• Serve as SME at Country level for all contract related activities
• Perform negotiation of legal terms and budget terms for the assigned Sites for all  Clinical Study Agreements and Amendments following principles document and comments & fallbacks.
• Draft, negotiate and execute ancillary site contracts (e.g. PI / Sub-I / department agreements /Study Coordinator) as required.
• Perform local budget adaptation as per local requirements and FMV (Fair Market Value).
• Support and provide country/cluster level intelligence into the selection of signing party at the country/cluster level which must consider payment impact, tax issues (VAT / R&D / WHT), establishment (i.e. Corporate presence).
• Support the approval and signature collection process for the Contract at site level
• Ensure metrics are up to date and accurate on tracking and reporting of Clinical Site Agreements progress in CTMS and/or other applicable systems.
• Ensure fully executed Agreements are filed in the appropriate Legal system and department repositoriesIdentify and proactively raise issues and risks on contract execution to the Global Contract Lead, as appropriate, prior to their becoming critical

Your role

• Bachelor's degree or Master's level in science field preferred
• 3-5 years of relevant experience in the required role
• Legal background desirable
• Key Competencies: Adaptability/Flexibility, Critical Thinking, Strong Communication Skills, Business Partnering, Drug Development, Planning & Organization, Project Management, Reliability of Work, Set Vision and Strategy, Vendor Management
• Good knowledge of Contractual language, Budget development and negotiations
• Good oral and written English language communication, project management and change management skills.
• Technical knowledge in Microsoft Office, Adobe Acrobat, document management systems, and familiarity with, Veeva, SharePoint, CTMS, eTMF and concepts of structured content management.
• Knowledge of ICH-GCP and applicable laws and regulations.
• Experience working in a high-volume environment while maintaining both organization and the ability to multitask
• Good administrative and coordination skills
• Good time and priority management, ability to work efficiently under pressure
• Reliable, conscientious and confidential
• Motivated, shows initiative, is proactive and able to work independently as well as in a team
• Ability to work in an international/ multicultural matrix environment

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!

Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!