Global Contract Management Specialist – Pharma Development

BioSpace; Sofia (NM); On-site; USD 95,000 - 135,000; Full time

Job summary

AbbVie is seeking a Contract Management Specialist to oversee CDAs, CSAs, and budgets globally (excluding US, Puerto Rico and Japan). You will negotiate with investigator sites, manage timelines, and coordinate with Legal, Finance and Site Management to keep contracts off the critical path for study start-up.

Requirements include a health-related degree and 3+ years in clinical research with strong negotiation, regulatory, and language skills.

Qualifications

• Health-related degree preferred (Medical, Scientific, Nursing).
• 3+ years clinical research experience including contract negotiation.
• Understanding of medical and legal terminology in clinical research.
• ICH/GCP knowledge and local regulatory familiarity.
• Ability to learn legal/compliance concepts in clinical research.

Responsibilities

• Serve as the point person for country/region for Legal, Finance, Site Management & Monitoring and Study Team.
• Ensure timely preparation and execution of CDAs, CSAs and Budgets.
• Direct negotiation of CDAs, CSAs and Budgets with sites using templates and Legal guidance.
• Input into legal aspects of Informed Consents to ensure rapid resolution.
• Liaise with Legal for deviations and approvals.
• Set priorities with local affiliates, Legal, and Finance in alignment with study plans.
• Provide input into updating playbooks and templates with Legal.
• Track CDAs and CSAs in the appropriate systems and collect metrics.
• Communicate site intelligence to stakeholders in Study Team, Legal, Finance, etc.
• Ensure CDAs and CSAs are off the critical path for start-up or conduct.

Skills

Contract negotiation

Clinical research

Budget management

Regulatory knowledge

English fluency

Education

Clinical research degree

Health-related qualification

Job description

AbbVie is seeking a Contract Management Specialist to oversee CDAs, CSAs, and budgets globally (excluding US, Puerto Rico and Japan). You will negotiate with investigator sites, manage timelines, and coordinate with Legal, Finance and Site Management to keep contracts off the critical path for study start-up.

Requirements include a health-related degree and 3+ years in clinical research with strong negotiation, regulatory, and language skills.