Investigator Contracts Lead - Manager (m/f/d)

ZipRecruiter; Ingolstadt; Remote; EUR 70.000 - 100.000; Vollzeit

Zusammenfassung

A leading company is seeking an Investigator Contracts Lead to manage contract and budget negotiations for clinical investigator sites. Responsibilities include developing site budgets, negotiating contracts, and ensuring compliance with timelines in a remote work setting. Ideal candidates will have significant experience in clinical development and a strong legal background.

Qualifikationen

• 5+ years of experience in clinical development operations or outsourcing.
• Experience with clinical study budgets and contract negotiations.
• Ability to work in a matrix organization.

Aufgaben

• Negotiate site budgets and contracts for clinical studies.
• Manage site contracting timelines and relationships.
• Collaborate with internal teams to resolve issues.

Kenntnisse

Communication

Leadership

Risk Management

Ausbildung

Bachelor's degree

US Juris Doctorate or equivalent legal degree

Jobbeschreibung

Job Description

The Investigator Contracts Lead is responsible for direct site-facing contract and budget negotiations from contract initiation to execution with assigned clinical investigator sites. This includes managing initial agreements, amendments, and overseeing other contracting professionals on assigned studies. The role also involves managing the Per-Subject Cost (PSC) process, handling escalation and resolution of budget and non-legal issues, and collaborating with other teams to plan site contracting timelines during start-up.

Responsibilities include:

1. Exercise good judgment to balance Pfizer's risks in making budget and contractual decisions against clinical trial timelines.
2. Follow GPD processes to develop, negotiate, track, and execute global clinical study agreements.
3. Develop and oversee the global site budget process.
4. Negotiate costs, business, and contractual terms with investigators and institutions, making changes within approved templates.
5. Build and maintain relationships with investigational sites and Site Management Organizations.
6. Lead study-level site contracting activities and serve as the primary contact for site contracting issues.
7. Partner with Legal and other divisions to manage escalations and improve processes.

Qualifications:

• 5+ years of experience in clinical development operations or outsourcing, with a bachelor's degree.
• Experience with clinical study budgets and contract negotiations.
• Strong communication and presentation skills.
• Ability to mitigate risks to contracting timelines.
• Proven leadership and ability to work in a matrix organization.

Additional Qualifications:

• 2+ years of experience in clinical development or outsourcing, with a US Juris Doctorate or equivalent legal degree.
• Experience in drafting and negotiating Clinical Trial Agreements globally.

Work Location: Remote

Our Values: Courage, Excellence, Equity & Joy. We foster a culture of innovation, responsibility, diversity, and joy in our work and community involvement.