Study Contract Manager

2 months ago

Mississauga, Canada AstraZeneca Full time

Please note this is a 12 month contract

At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation - ultimately providing employees with the opportunity to work across teams, functions and even the globe.

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 and BlueSky Hub in downtown Toronto are purposely designed with collaboration in mind, providing space where teams can come together to strategize, brainstorm and connect on key projects.

Our dedication to sustainability is also central to our culture and part of what makes AstraZeneca a great place to work. We know the health of people, the planet and our business are interconnected which is why we’re taking ambitious action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention.

The Study Contract Manager (SCM) play a meaningful role in driving the costings and contracts being responsible for negotiation and budgeting in clinical trials and for developing and managing contracts and annexes with investigators and institutions or external vendors ensuring ethical, fair and compliant practices.

SCM has regular communication with investigators and institutions as well as other key external and internal stakeholders.
- SCM might have different internal titles based on the experience level (SCM, Senior SCM). The experience level depends on the years of experience, performance record, level of independence in the role, ability to take on additional tasks or tutor more junior colleagues. The Director, Country Head may assign this internal title after confirmation with Senior Director, Cluster Head or Executive Director, Regional Head). _

**Typical Accountabilities**
- Adapt global templates of agreements to local use in accordance with local requirements and SOP's.
- Develop and negotiate clinical site budgets based on Fair Market Value.
- Parlay agreement language and budget with clinical study sites.
- Act as point of contact and work with Legal if vital to ensure integrity of contracts.
- For each agreement maintain the status of agreement, budgets, issues, payments, any amendments for the duration of the study, and communications with all sources
- Ensure final contract documents are consistent with agreements reached at negotiations.
- Ensure all agreements are implemented in a timely manner giving 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.
- Support preparation and conference of a Local Master Service Agreement
- Contribute to process improvements, knowledge transfer and standard methodology sharing.

**Education, Qualifications, Skills and Experience**
- Bachelor degree in related field, preferably in life science, law, finance or equivalent qualification.
- Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP.
- 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
- Ability to work in an environment of remote collaborators.
- Post-graduate training in contracts administration or work experience as a paralegal in pharmaceutical or health care industry
- Manages change with a positive approach for self, team and the business. Sees change as an opportunity to improve performance and make valuable contributions to 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 cultural awareness.
- Ability to understand the impact of technology on projects and to use and develop digital literacy while making appropriate use of systems/software in an e-enabled environment.
- Team oriented and flexible; ability to respond quickly to shifting demands and opportunities.
- Good medical knowledge and ability to learn relevant AZ Therapeutic Areas.

Great People want to Work with us Find out why:

- GTAA Top Employer Award for 9 years
- Learn about our culture
- Learn more about working with us in Canada
- View our YouTube channel

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