Study Contract Manager, Cell Therapy

The Study Contract Manager (SCM) is integral to driving the financial and contractual aspects of clinical trials. This role involves developing, negotiating, and managing contracts and budgets for clinical study sites, ensuring compliance with ethical and regulatory standards. The SCM acts as a key liaison between investigators, institutions, vendors, and internal stakeholders, overseeing the entire contract lifecycle to ensure timely execution and adherence to study timelines.

Key Responsibilities:

• Adapt global contract templates for local use, ensuring compliance with local regulations and SOPs.

• Develop and negotiate clinical site budgets based on Fair Market Value (FMV).

• Negotiate contract terms and budgets with clinical study sites.

• Interface with Legal as necessary to ensure contract integrity and compliance.

• Monitor the status of contracts, budgets, amendments, payments, and related communications throughout the study lifecycle.

• Ensure that final contracts align with negotiated terms and agreements.

• Ensure the timely execution of contracts to support efficient site start-up and study timelines.

• Maintain all contracts in the Trial Master File (TMF).

• Ensure adherence to AstraZeneca’s Code of Conduct and company policies, covering finance, technology, and security.

• Support internal and external audits to ensure contractual and financial compliance.

• Mentor and train new team members on financial and contractual matters.

• Contribute to the preparation and negotiation of Local Master Service Agreements.

• Actively engage in process improvement initiatives and share best practices within the team.

Essential Skills & Experience:

• Bachelor's degree in a relevant discipline (Life Sciences, Law, Finance, or related field) or equivalent qualification.

• Strong understanding of international guidelines such as ICH-GCP, and basic knowledge of GMP/GDP.

• Familiarity with local regulatory requirements and the drug development process.

• Knowledge of clinical study management, including monitoring, data management, and study drug handling.

Desirable Skills & Experience:

• Cell Therapy experience

• Experience in working remotely or with geographically dispersed teams.

• Post-graduate training in contract administration or experience as a paralegal within the pharmaceutical or healthcare industry.

• Proven ability to embrace and manage change, seeing it as an opportunity for improvement.

• Strong analytical and problem-solving capabilities.

• Experience with risk-based monitoring and remote monitoring practices.

• Ability to prioritize and manage multiple tasks with conflicting deadlines.

• Familiarity with e-enabled environments and technological tools used in clinical trials.

• Strong cultural awareness and flexibility in team environments.

• A team-oriented, adaptable approach to shifting demands and opportunities.

WHY JOIN US?

At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients, and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth, and development. We’re on an exciting journey to pioneer the future of healthcare.

SO, WHAT’S NEXT?

To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity.  If you know someone who would be a great fit, please share this posting with them.

Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week. Our head office is purposely designed with collaboration in mind, providing space where teams can come together to strategize, brainstorm and connect on key projects.

Great People want to Work with us! Find out why:

• GTAA Top Employer Award for 10 years
• Top 100 Employers Award
• Canada’s Most Admired Corporate Culture
• Learn more about working with us in Canada
• View our YouTube channel

Are you interested in working at AZ, apply today!

AstraZeneca is an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination. AstraZeneca is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process and may be requested by emailing AZCHumanResources@astrazeneca.com.

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.