AssDir, Start-up Solutions Lead
Merck KGaA Darmstadt Germany Posted on 2022-11-18
| Salary | Not mentioned |
|---|---|
| Location | Remote in London TW14 |
| Type | Full-time |
Job Description
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 the Start-Up Solutions Lead you report into the Head of CSA and serve as clinical study agreement, CSA, delivery expert for Ph I – IV trials and oversee the CSA delivery performance at study level. You will review and approve any CSA contractual adaptation (study, country or site level), that is outside of the CSA guidance document and legal manual, with support from legal counsel and/or other internal expert functions, this will include ad hoc interactions to address immediate issues on CSA negotiations and finalization. You will support agreements across 66 countries worldwide and will act as a true global partner, serving as the point of escalation to study teams on clinical site budget and agreement issues, facilitating resolution to their issues.
Key responsibilities will include, but are not limited to:
- Ensure globally approved CSA templates are utilized at study level and coordinate the revisions of Master Clinical Site Agreement templates and Legal Manuals.
- Develop and update, with internal and external business partners, a negotiating parameter guidance documents (which include agreed grant plan budget limit, contract language, apply forward terms and fixed item cost sheets) at Country and Site level (as needed).
- Manage global development CSS, CRS site Agreements & ISS Agreements templates with clear instruction and guidance
- Coordinate and review of Fair Market Value (FMV) of investigator grant evaluation
- Perform Clinical Site & ISS Agreements customization and interface with Legal where required
- Perform Confidentiality Agreement customization and interface with Legal where required
- Coordinate Confidentiality Agreement escalation, evaluation and feedback across the portfolio (CRS, CSS, ISS and global development)
- Manage contract signature process for Clinical Site & ISS agreements, global development CSA and other legal documents are required
- Track and document Clinical Site and ISS agreements, CSA, CDA, other legal documents across the portfolio as required
- Support review of CSA adaptation (study, country or site level), that is outside of the CSA guidance document and legal manual, with support from legal counsel and/or other internal expert functions
- Facilitate legal document template review
- Coordinate, support and manage budget build for CSS, CRS and global development CSA at study, country or site level
- Accountable for Study Budget Listing creation for the ISS, CRS and CSS
This role will work remotely and could be based anywhere across Europe.
Who you are:
- You hold a degree, or equivalent, in a relevant scientific or legal subject.
- You have extensive proven experience working with Clinical Study agreements at global level within pharma, Biotech or CRO.
- Must have extensive operational clinical trial support experience with an in-depth knowledge of the needs from both an internal and CRO perspective.
- Must be pro-active and able to work in high pressure, fast paced environments.
- A legal professional background would be advantageous
- Additional language skills would be advantageous but are not required.
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. We believe that it drives excellence, innovation, and human progress. We care about our customers, patients, and our rich mix of people. This diversity strengthens our ability to lead in science and technology. We are committed to creating access and opportunities for all and empower you to fulfil your ambitions. Our diverse businesses offer various career moves to seek new horizons. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to bring their curiosity to life!
Job Requisition ID: 258312
Location: Feltham
Career Level: E – Professional (10+ years)
Working time model: full-time
North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our Candidate Services team at 844-655-6466 from 8:00am to 5:30pm ET Monday through Friday. If you are a resident of a Connecticut or Colorado, you are eligible to receive additional information about the compensation and benefits, which we will provide upon request. You may contact 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday, for assistance.
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Company description:
Merck is a global science and technology company with a passion for forward-thinking discoveries. We want to develop products and solutions for a better life. That »s why we take a closer look at things, ask questions and think ahead. We »ve been around for almost 350 years, yet the great majority of our shares are still held by the descendants of Friedrich Jacob Merck, the man who founded our company in Darmstadt in 1668. To us, our 50,000 employees are more than lab coats, blue-collars, suits or faces amongst many others. Around the world we employ discoverers, we clear the way for pioneers and encourage bold innovators. Our business sectors Healthcare, Life Science and Performance Materials contribute to shaping how our world lives, works, and plays through next generation advancements in science and technology. From improving electronic devices with smarter materials to generating ultra pure water, testing the quality of food and drugs, and treating cancer, Merck always promotes opportunities to break new ground. We are Merck. The only exceptions to this are in the USA and Canada. Here we operate in the biopharma market as EMD Serono, in life science as MilliporeSigma, and in the specialty chemicals and high-tech materials business area as EMD Performance Materials.
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