Associate Director, Trial Clinical Delivery Lead

at  Merck Group

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.

MINIMUM REQUIREMENTS:

• Bachelor’s Degree Medical or Life Sciences degree in a clinical research related discipline or equivalent with 10+ years of experience.
• Clinical operations experience
• Expert knowledge of clinical development (principles and concepts as well as regulatory environment e.g., ICH GCP and applicable regional/local regulations

PREFERRED REQUIREMENTS:

• Oncology and/or Neurology and/or Immunology TA experience desired
• (10+ years) professional and project management experience in clinical research in a CRO, pharma or biotech company including site management/oversight, clinical study planning and conduct.
• Exhibit strong interpersonal skills: Adaptability / Flexibility, Critical Thinking, Strong Communication Skills, Analytical Skills, Business Partnering, Clinical Trials Knowledge, Influencing Skills, Strategic Thinking, Therapeutic Area Knowledge, and cultural awareness to effectively lead and collaborate with diverse teams.
• Ability to work independently on assigned tasks or projects.
• Aptitude to interpret outputs from analytical tools to enhance and improve study execution.
• Ability to assess risk, solve problems and take decisions.
• Demonstrated ability to handle and oversee multiple tasks simultaneously and to prioritize in a meaningful way.
• Comfortable working in a fast‐paced environment where speed is paramount.
  What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it 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 our diverse team!

• 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