Trial Clinical Delivery Lead

 

Work Your Magic with us! Start your next chapter and join EMD Serono.

 

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.

 

Your role:

• Accountable for the delivery and quality of site level activities in Phase I-IIIb Clinical Development studies; act as link between Clinical Site Leads (CSLs), Global functions & CRO counterparts - single point of contact for site management & operational topics/escalations; support information channeling and issue resolution for the study
• Provide leadership, strategic direction, and operational oversight for Clinical Site Lead (CSL) activities across assigned study(ies) in response to quality and performance oversight measures and trends.
• Serve as the operational delivery expert for the study(ies) and promote data-driven, realistic planning at the site and study level.  Drive delivery-focused accountability and ownership amongst key external (CRO/vendor partners) and internal partners as appropriate
• Facilitate identification and implementation of operational excellence strategies within studies - leveraging expertise within Global Development Operations (GDO) and other partner functions.
• Ensure timely and appropriate escalation of trends, issues, and risks within the Clinical Operations Team/Clinical Trial Team/CRO/Vendor Team, department Leadership Team and/or Senior Management as appropriate.
• Promote solution-orientated thinking and issue resolution at the country and study team level. Provide an escalation pathway to ensure study-specific major observations from CSLs are relayed to and followed up by the appropriate internal and/or external business partners.
• Support product and study-specific onboarding for new CDPC team members and contribute to enhancing their site/study management capabilities/skills.
• Promote Product Knowledge ensuring all team members understand trial assets and protocols. Foster Collaboration: Encourage regular communication and teamwork between sites and stakeholders.
• Streamline Information Sharing: Use clear channels to share updates and information.
• Develop Best Practices: Contribute to and follow guidelines for consistent site and study management.
• Lead regular calls with CSLs working on study and/or other activities within the assigned study(ies)
• Act as functional lead for process improvement initiatives

 

As a member of the Clinical Trial Team:

• Represent the CSL group at the Clinical Operations Team (COT)/Clinical Trial Team (CTT) via:
  • Regular review meetings of study/site performance and quality metrics and the associated strategic action planning
  • Ad hoc interactions to address immediate issues.
  • Other COT/CTT meetings as appropriate e.g., kick-off meeting
• Consolidate and assess data-driven proposals for selecting countries and sites, ensuring quality and consistency across regions. Provide clear, actionable information to Clinical Trial Teams (CTTs) to support their decision-making and keep Clinical Site Leads (CSLs) informed of the final selection of regions, countries, and sites.
• Lead activities with internal and external stakeholders to proactively gather and integrate patie