Study Contract Manager

$105,735 - $158,602/Yr

AstraZeneca - Wilmington, NC

- Mid Level

Wilmington, NC

Chemical Manufacturing

About the position

The Study Contract Manager (SCM) plays an important role in driving the costings and contracts, being responsible for negotiation and budgeting in clinical trials. The SCM develops and manages contracts and annexes with investigators, institutions, or external vendors, ensuring ethical, fair, and compliant practices. Regular communication with investigators, institutions, and other key external and internal stakeholders is a key aspect of this role.

Responsibilities

• Adapt global templates of agreements to local use in accordance with local requirements and SOPs.
• Develop and negotiate clinical site budgets based on Fair Market Value.
• Negotiate agreement language and budget with clinical study sites.
• Act as point of contact and interface with Legal if necessary to ensure integrity of contracts.
• Maintain the status of agreements, budgets, issues, payments, any amendments for the duration of the study, and communications with internal and external sources.
• Ensure final contract documents are consistent with agreements reached at negotiations.
• Ensure all agreements are executed in a timely manner contributing to efficient site start-up timelines.
• Support internal and external audit activities.
• Ensure compliance with AstraZeneca's Code of Conduct and company policies and procedures relating to people, finance, technology, and security.
• Ensure that all contracts are included in the TMF.
• Train and mentor new members of the local Study Team regarding financial/contractual issues and share experiences.
• Support preparation and negotiation of a Local Master Service Agreement.
• Contribute to process improvements, knowledge transfer, and best practice sharing.

Requirements

• Bachelor degree required in related discipline, preferably in life science, law, finance or equivalent qualification.
• Minimum of 2 years of experience negotiating industry contracts such as Clinical Study Agreements for site, SMO, CRO, Sponsor.
• Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP.
• Comfortable with Excel, Microsoft Word track changes.
• Good knowledge of relevant local regulations.
• Basic understanding of the drug development process.
• Good understanding of Clinical Study Management including monitoring, study drug handling, and data management.
• Excellent attention to details.
• Good written and verbal communication skills.
• Good collaboration and interpersonal skills.
• Good negotiation skills.

Nice-to-haves

• Experience working in Salesforce or contract negotiation platforms.
• Ability to work in an environment of remote collaborators.
• Post-graduate training in contracts administration or work experience as a paralegal in the pharmaceutical or health care industry.
• Manages change with a positive approach for self, team, and the business.
• Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time.
• Good analytical and problem-solving skills.

Benefits

• 401(k) plan
• Paid vacation and holidays
• Paid leaves
• Health benefits including medical, prescription drug, dental, and vision coverage
• Short-term incentive bonus opportunity
• Eligibility to participate in equity-based long-term incentive program (salaried roles) or to receive a retirement contribution (hourly roles)