Sr Clinical Site Lead

2 settimane fa

Roma, Italia Merck KGaA Darmstadt Germany A tempo pieno

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.

**Your Role**:
As an Associate Director, Senior Clinical Site Lead working across therapeutic areas, you are accountable at the country level for overseeing delivery and quality of site activities; implementation of site engagement strategies; identification and mitigation of risks to ensure successful execution of outsourced Phase I-III trials in the clinical development portfolio. Being a strong clinical operations expert, influencer, and communicator - you will establish site relationships to build investigator and site staff knowledge of our development compounds; collaborate with global and local teams and Patient/Industry Associations to raise the company profile and awareness of our trials with current and potential investigators; and use your knowledge of site capabilities and past performance to assess their potential as investigational sites for our trials. In collaboration with external vendors and the internal Trial Team, you will pro-actively utilise site performance and quality data analytics to engage with investigational sites to achieve expected enrolment and conduct risk-based sponsor oversight activities. You will recognize and develop talent through empowerment and performance feedback and you will ensure team environment in which everyone strives.

**Who are you:
- Bachelor's Degree in a Medical or Life Science discipline (essential); PhD desirable
- 10 years clinical operations experience from a CRO, pharma and/or biotech company
- Substantial experience in site management/oversight (including management/oversight of CRA teams and/or Lead CRA experience), vendor management/oversight
- Thorough knowledge of ICH GCP and global/local country regulations
- Ability to work independently on assigned tasks or projects of increasing complexity
- Capability to perform self-training and able to lead, coach and train other team members
- Proven management and leadership skills
- Proactive, deliverable focused and solution orientated with clear understanding of ownership and accountability
- Approaches change positively; adapts behaviour or work methods in response to new information, changing conditions, or unexpected obstacles
- Strong analytical skills, aptitude to interpret outputs from analytical tools to enhance and improve study execution
- Comfortable working in a fast-paced environment where speed is paramount
- Aptitude to network and use appropriate interpersonal styles to establish constructive working relationships with peers and partners to meet mutual goals and objectives
- Strong communication skills - verbal, written and listening - both in native language and English
- Experience in/knowledge of patient and site centric activities, recruitment and retention strategies and technologies
- Broad therapeutic area experience ideally relevant to our company portfolio

**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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