Voir tous les résultats
AssDir, Start-up Solutions Lead
A career at our company is an ongoing journey of discovery: our 60,300 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.
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.
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!