Coss 0, Associate Director, Ssul, Clinical Site Agreements

London, ENG, GB, United Kingdom

Job Description

Job Id
289985
Feltham, London, United Kingdom
Job Type
Full-time

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.



Work your magic with us!





Merck is looking for a Global Clinical Site Agreement (CSA) Lead that will be responsible to support the following activities as part of the Start-up Solution Unit Team:

Drive with internal and external business partners in developing the CSA Strategy Plan at study level Serve as CSA delivery expert for high priority studies and oversee the CSA delivery performance at study level 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. Lead, develop and update negotiating parameter guidance documents (which include agreed grant plan budget limit, contract language, apply forward terms and fixed item cost sheets) with internal and external business partners at Country and Site level (as needed) 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


Please be aware that this position is remote, and we offer flexibility regarding the location.



We're searching for candidates with the following expertise:

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 At least 5 years of experience in contract and budget negotiation at Global or Regional level (at least) Experience in oversight of external service providers, preferred Experience in the management of contracts related to additional HCP activities (e.g. SMC, IDMC,...), preferred Thorough knowledge of ICH-GCP and applicable laws and regulations for key countries

What we offer:

We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety 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!



and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!





US Equal Employment Opportunities

The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

Notice on Fraudulent Job Offers
Unfortunately, we are aware of third parties that pretend to represent our company offering unauthorized employment opportunities. If you think a fraudulent source is offering you a job, please have a look at the following information here.



Applicant Profile

Along with our brand-new career site, we've also revamped our application process. If you've applied for a position before April 16th 2025, you can log into your old profile to see the status of past applications. For the application you've will completed, and any in the future, you can create a new profile to check in on your status.
WHAT WE OFFER
Money makes the world go round. But at our company there's more than just financial rewards. We offer a range of attractive benefits to help you work your magic.
Saving & Finacial
Our 401(k) Plan includes a generous company-matching contribution and an additional discretionary contribution each year.
We also provide tax-advantaged accounts for you to save for healthcare, commuting expenses, company-provided and buy-up life insurance to help you protect your financial future.
Health & Wellness
We offer comprehensive medical, dental, & vision coverage-including virtual care through Telehealth & free behavioral health counseling sessions through our Employee Assistance Program.
We also offer a wellness incentive program and personalized support to help you navigate and use your benefits.
Voluntary Benefits
Our voluntary benefits provide additional protection from the high costs of healthcare not covered by health insurance.
We also have discount programs that offer exclusive savings on everything from auto, home, and pet insurance to low-interest personal loans.
Work/Life Support
We have several programs to support your work/life balance, including generous paid time off, back-up day care services, education assistance, and more.
OUR RECRUITING PROCESS
Depending on the position (level, functional area, country) the process can vary slightly.
You apply
Complete your online application for your preferred role(s) that match your interests and qualification. If you cannot find a suitable role please join our Talent Zone and stay connected for your next career opportunity.
We screen
We review your application and if we determine that you are a good fit we will move you to the selection process.
We assess
You are interviewed by phone, via video and/or face to face.
Mutual agreement
Ideally you are the perfect match for us! We hope you consider us as your new employer.
Work your magic!
To guarantee you a smooth start our onboarding preparation begins.
Haven't found the right job yet?
Join our Talent Community to stay connected and explore future opportunities.

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Job Detail

  • Job Id
    JD3608584
  • Industry
    Not mentioned
  • Total Positions
    1
  • Job Type:
    Full Time
  • Salary:
    Not mentioned
  • Employment Status
    Permanent
  • Job Location
    London, ENG, GB, United Kingdom
  • Education
    Not mentioned