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

ZipRecruiter; Ulm; Remote; EUR 65.000 - 95.000; Vollzeit

Zusammenfassung

A leading company in clinical research is seeking an Investigator Contracts Lead. This remote role involves negotiating site-facing contracts and overseeing budget processes throughout clinical trials. The ideal candidate will have significant experience in clinical development and strong leadership capabilities, as they will manage escalation issues and collaborate with various teams.

Qualifikationen

• 5+ years in clinical development operations or outsourcing.
• Experience with clinical study budgets and contracting principles.

Aufgaben

• Managing site-facing contract and budget negotiations.
• Developing and overseeing the global site budget process.
• Leading study-level site contracting activities.

Kenntnisse

Communication

Risk Mitigation

Leadership

Organizational Skills

Ausbildung

Bachelor's Degree

Jobbeschreibung

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

The key responsibilities include:

1. Exercising good judgment in balancing Pfizer's risks in budget and contractual decisions against clinical trial timelines.
2. Following GPD processes to develop, negotiate, track, and execute global clinical study agreements.
3. Developing and overseeing the global site budget process.
4. Negotiating costs, business, and contractual terms directly with investigators/institutions, within approved legal templates.
5. Building relationships with key investigational sites and Site Management Organizations.
6. Leading study-level site contracting activities and acting as the primary contact for site contracting issues.
7. Partnering with Legal and other divisions to manage escalations and improvements in site contracting.

Basic qualifications include:

• 5+ years of experience in clinical development operations or outsourcing, with a bachelor's degree.
• Experience with clinical study budgets and contracting principles.
• Strong communication, risk mitigation, leadership, and organizational skills.

Preferred qualifications include:

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

Work location: Remote