Study Contract Manager

2 months ago

Mississauga, Canada AstraZeneca Full time

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**:

- 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?**

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

  • Global Study Manager

    7 months ago

    Mississauga, Canada AstraZeneca Full time

    **Global Study Manager, 12 Month Contract** **Hybrid Work - on average 3 days/week from office** **Minimum 1 day from our Mississauga office and 2 days from our Mississauga or Downtown office** At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation - ultimately providing...

  • Global Study Manager

    5 days ago

    Mississauga, Canada AstraZeneca Full time

    **Global Study Manager (12 month contract)** **Mississauga, Canada (hybrid work - average of 3 days in office)** **Competitive salary and benefits** 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...

  • Global Study Manager

    7 months ago

    Mississauga, Canada AstraZeneca Full time

    This is a 12-month contract. The Global Study Manager is a member of the extended global study team supporting delivery of clinical studies within BioPharmaceuticals Clincal Operations, Study Management to time, cost and quality, from Clinical Study Protocol (CSP) development through study set-up, maintenance, close-out, development of Clinical Study Report...

  • Study Delivery Associate

    7 months ago

    Mississauga, Canada AstraZeneca Full time

    **Study Delivery Associate (12 Month Contract)** **Hybrid Work - 3 days a week from our Mississauga, Canada office** 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...

  • Global Study Associate

    7 days ago

    Mississauga, Canada AstraZeneca Full time

    **Global Study Associate (12 month contract)** **Multiple Openings** **Mississauga, Canada (hybrid work - average of 3 days in office)** **Competitive salary and benefits** **Make a more meaningful impact to patients’ lives around the globe** At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing,...

  • Study Delivery Associate

    3 months ago

    Mississauga, Canada AstraZeneca Full time

    The Study Delivery Associate assists in the coordination and administration of the study activities from the start up to execution and close out, and within the Local Study Team (LST) to ensure quality and consistency of interventional study deliverables to time, cost and quality objectives. **Your responsibilities include**: - Assists in coordination and...

  • Global Study Manager, Oncology

    7 months ago

    Mississauga, Canada AstraZeneca Full time

    **Global Study Manager, Oncology** **6 Month Contract** **Hybrid Work - 3 days/week from Mississauga office** 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...

  • Global Study Associate

    7 months ago

    Mississauga, Canada AstraZeneca Full time

    This is a 12-month contract. The Global Study Associate is a member of the extended global study team supporting delivery of clinical studies within BioPharmaceuticals Clinical Operations, Study Management to time, cost and quality. The GSA supports delivery of global clinical studies from study set-up through maintenance, close-out and study archiving. The...

  • Study Manager

    2 months ago

    Mississauga, Canada GSK Full time

    **Site Name**: Mississauga Milverton Drive **Posted Date**: Nov 23 2024 **Job Purpose**: - Study Manager (SM) is a key member of the Global Study Team contributing to delivering the clinical study to time, cost and quality, and ensuring inspection readiness by taking an oversight over study eTMF completeness. - SM role was implemented to have a broader...

  • Study Manager

    3 months ago

    Mississauga, Canada GSK Full time

    **Site Name**: Mississauga Milverton Drive **Posted Date**: Oct 15 2024 **Job Purpose**: - Study Manager (SM) is a key member of the Global Study Team contributing to delivering the clinical study to time, cost and quality, and ensuring inspection readiness by taking an oversight over study eTMF completeness. - SM role was implemented to have a broader...

  • Global Study Associate, Smo

    1 month ago

    Mississauga, Canada AstraZeneca Full time

    **Global Study Associate, SMO** **12 Month Contract** **Hybrid Work - on average 3 days/week from office** **Minimum 1 day from our Mississauga office and 2 days from our Mississauga or Downtown office** At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation - ultimately...

  • Study Delivery Associate

    7 months ago

    Mississauga, Canada AstraZeneca Full time

    **Study Delivery Associate (12 Month Contract)** **Hybrid Work - 3 days/week at our Mississauga, ON office** 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...

  • Global Study Manager

    4 days ago

    Mississauga, Canada AstraZeneca Full time

    Headquartered in Mississauga, Ontario, AstraZeneca has been recognized as a Greater Toronto Area Top Employer for eight straight years. We pride ourselves on creating a collaborative culture that champions knowledge-sharing, entrepreneurial thinking and innovation - ultimately providing employees with the opportunity to work across teams, functions and even...

  • Global Study Manager

    2 days ago

    Mississauga, Canada AstraZeneca Full time

    Location: Mississauga office (Hybrid 3 days in office) 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,...

  • Global Study Associate

    2 weeks ago

    Mississauga, Canada AstraZeneca Full time

    **Global Study Associate, Oncology (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...

  • Global Study Manager

    3 months ago

    Mississauga, Canada AstraZeneca Full time

    The GSM is a member of extended global study team supporting delivery of clinical studies within Late Development Oncology (LDO) to time, cost and quality, from Clinical Study Protocol (CSP) development through study set-up, maintenance, close-out, development of Clinical Study Report (CSR) to study archiving. The GSM works cross-functionally with internal...

  • Global Study Manager

    7 months ago

    Mississauga, Canada AstraZeneca Full time

    **Short role description**: The Global Study Manager is a member of the extended global study team supporting delivery of clinical studies within BioPharmaceuticals Clinical Operations, Study Management to time, cost and quality, from Clinical Study Protocol (CSP) development through study set-up, maintenance, close-out, development of Clinical Study Report...

  • Account Manager Ll

    2 months ago

    Mississauga, Canada Contract Pharmaceuticals Full time

    **WHO WE ARE**: At CPL, we are passionate about pharmaceutical product development and contract manufacturing. Our aim is to be the top choice CDMO in the non-sterile liquid and semi-solid pharmaceutical products domain, and ultimately bring benefits to the customers using our manufactured products. For more than 30 years CPL has partnered with the...

  • Global Study Associate Director

    7 months ago

    Mississauga, Canada AstraZeneca Full time

    **Global Study Associate Director** **Hybrid Work - 3 days/week from our Mississauga office** 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...

  • Global Study Manager, Haematology

    7 months ago

    Mississauga, Canada AstraZeneca Full time

    **Global Study Manager, Haematology (CAR-T Program)** **12 Month Contract** **Hybrid Work - 3 days/week from Mississauga office** 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...