Senior Clinical Trial Lead

vor 2 Wochen

Darmstadt, Deutschland Merck KGaA Vollzeit

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.

**Job Title: (Senior) Clinical Trial Lead (all genders)**
- Lead the development of the clinical trial operational strategy while accountable for successful project execution and delivery of clinical operational plan within the budget, timelines and quality standards agreed upon by Governance Committees.
- Manage multiple studies with high complexity, risk, impact, and reach, typically Ph III and registrational/pivotal studies, and ensures all study management activities will be completed in accordance with SOPs/WI, local regulatory guidance including ICH-GCP, MDR (MPDG)
- Leads global trial teams in a matrix organization and directs, influences, and motivates people and aligns clinical trial team with organizational goals and objectives of the Program Team.
- Leads activities with internal and external stakeholders to proactively gather and integrate patient and physician insights into study design and conduct (e.g., utilizing Patient and Site advisory boards, social media campaigns, surveys, interactions with patient advocacy groups/organizations etc.)
- Acts as link between internal functions & CRO counterparts, point of contact for site management & operational topics/escalations, support information channeling and issue resolution for the study Ensures timely and appropriate escalation of trends, issues, and risks within the Project Team/Clinical Trial Team/CRO/Vendor Team, department Leadership Team and/or Senior Management as appropriate

**Who you are**:

- 7-12 years in clinical research in a CRO or industry environment with at least 5 years of in-depth knowledge and experience in clinical trial management including managerial responsibility.
- Expert knowledge of clinical development principles and concepts as well as regulatory environment e.g., ICH GCP, ideally MDR (MPDG) and applicable regional/local regulations.
- Advanced degree desirable; PM certification (CAPM, PMP) desirable.
- Proven experience in all aspects of clinical study planning and startup (including budget and resource planning) and in executing the complete range of clinical study activities, from startup through final study report. Medical devices clinical trial management experience desirable.
- Experience in multiple therapeutic areas (e.g., inflammatory diseases, cardio-vascular diseases, pneumology) desired
- Proven team dynamic knowledge and skills and ability to foster partnerships across projects and multidisciplinary teams. Fluency in English required, German language knowledge desirable.

**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

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