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

JR Germany; Ingolstadt; Remote; EUR 70.000 - 100.000; Vollzeit

Zusammenfassung

A leading company in the clinical development field is seeking an Investigator Contracts Lead to manage and negotiate contracts with investigator sites. The ideal candidate will have over seven years of experience in clinical development operations, demonstrating expertise in budget management, compliance, and stakeholder collaboration. This role offers the opportunity to work remotely while leading complex negotiations in a dynamic environment.

Qualifikationen

• 7+ years in clinical development operations.
• Extensive experience with clinical study budgets.
• Strong understanding of compliance, finance, and drug development.

Aufgaben

• Manage contract and budget escalations effectively.
• Negotiate costs and contractual terms with investigators.
• Coordinate with invoicing teams to ensure compliance.

Kenntnisse

Communication

Negotiation

Leadership

Ausbildung

Bachelor's degree or equivalent

Master's degree

Juris Doctorate or similar

Jobbeschreibung

Investigator Contracts Lead is responsible for direct site-facing contract and budget negotiations through 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 involves managing the Per-Subject Cost (PSC) process, handling escalations and resolutions for budget and non-legal issues, and collaborating on site contracting timelines during start-up phases. The Investigator Contracts Lead may serve as the primary contact for studies with high complexity or priority, requiring minimal oversight for planning and problem-solving.

Responsibilities include:

• Exercise independent judgment in site contracting decisions.
• Manage contract and budget escalations effectively.
• Make informed decisions balancing risks and trial timelines.
• Solve moderate complexity site contracting issues with innovative solutions.
• Develop, negotiate, and track global clinical study agreements.
• Oversee global site budget processes.
• Negotiate costs and contractual terms directly with investigators and institutions.
• Build and maintain relationships with investigational sites and Site Management Organizations.
• Lead negotiations with other ICLs, pCROs, and FSPs to meet study goals.
• Partner with Legal and other divisions to manage escalations and improve processes.
• Apply advanced knowledge of site contracting and budgets.
• Coordinate with invoicing teams to ensure compliance with contractual and compensation requirements.

Qualifications:

• 7+ years in clinical development operations or outsourcing, with a bachelor's degree or equivalent.
• Extensive experience with clinical study budgets and contracting.
• Strong understanding of business, compliance, finance, legal, and drug development aspects.
• Excellent communication and presentation skills.
• Ability to mitigate risks to timelines.
• Proven leadership by influence in a matrix organization.

Preferred:

• 5+ years with a master's degree.
• 2+ years with a Juris Doctorate or similar, with expertise in drafting and negotiating Clinical Trial Agreements.

Work Location: Remote

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