Clinical Site Agreement Lead

vor 7 Monaten

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.

**Your role:
- Drive with internal and external business partners, in the development of the CSA Strategy Plan at study level across Phase I-IV, that is in line with Country and Site Activation Strategy Plan.
- Serve as CSA delivery expert for high priority studies and oversee the CSA delivery performance at study level via:

- Review and approve any CSA contractual adaptation (study, country or site level), that is within the guidance document and legal manual, and independently lead discussion and resolution of complex items outside of the scope of the guidance document with support from legal counsel and/or other internal expert functions, if required.
- Regular review meetings of study/site performance and quality metrics on CSA execution and attend associated strategic action planning
- Ad hoc interactions to address immediate issues on CSA negotiations and finalization
- Other COT/TT meetings as appropriate, eg. kick-off meeting
- Serve as the point of escalation to CSA team members and study teams on clinical site budget and agreement process issues and facilitate resolution to the issues.
- Ensure globally approved CSA templates are utilized at study level and coordinate the revisions of Master Clinical Site Agreement/Master Confidentiality Agreement templates and Legal Manuals.
- Manage all global development, Company Sponsored Study (CSS), Collaborative Research Study (CRS) & Investigator Sponsored Study (ISS) Agreements template types independently
- Approve Fair Market Value (FMV) assessments for any complexity investigator grant evaluation across the portfolio independently
- Manage or approve high level estimates or budget build, for any complexity local regional CSS, CRS and global development trials at study, country or site level
- Perform Confidentiality Agreement customization across the portfolio and lead discussion with Legal where required
- Coordinate and lead Confidentiality Agreement escalation, evaluation and feedback across the portfolio (CRS, CSS, ISS and global development trials) Accountable for raising awareness of such trends/issues in CSA processes and facilitate solutions, working closely with relevant internal business partners and/or external partners, to ensure CAPA are defined and implemented. Raise awareness of trends/ issues (within and across program) with key internal/external partners, department Leadership Team and/or senior management as appropriate

**Who you are:
- Medical or Life Sciences degree or equivalent qualification. PM certification (CPM, PMP) is desirable
- At least 10 years in clinical research in a CRO or Pharmaceutical/Biotechnology Industry environment
- Understanding of the overall clinical development paradigm, especially in the area of clinical study operations and have global or regional experience
- Passionate about bringing the latest scientific discoveries to life, supporting the start-up phase of our Development Clinical Trials
- 3-5 years of project management and experience in contract and budget negotiation activities, preferred
- Experience in oversight of external service providers
- Thorough knowledge of ICH-GCP and applicable laws and regulations for key countries
- Experience in multiple Therapeutic Areas, especially in oncology and immuno-oncology
- Fluent in English

**Can be operated in Europe.
**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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