Senior Study Contract Manager

Parexel International; Ontario; Hybrid; CAD 80,000 - 100,000; Full time

Job summary

A leading company in the clinical research sector is seeking a Senior Study Contract Manager in the greater Toronto area. This hybrid role involves negotiating contracts and budgets for clinical trials, ensuring compliance and ethical practices. The ideal candidate will have strong communication skills and a background in life sciences or law, with a focus on detail and collaboration.

Qualifications

• At least 2 years of experience in site contract negotiation or customization.
• Excellent knowledge of ICH-GCP guidelines.

Responsibilities

• Developing and negotiating clinical site budgets based on Fair Market Value.
• Ensuring compliance with the client’s Code of Conduct and company policies.

Skills

Attention to Detail

Communication

Collaboration

Education

Bachelor’s degree in life sciences

Bachelor’s degree in law

Bachelor’s degree in finance

Job description

When our values align, there's no limit to what we can achieve.

Parexel has an exciting opportunity for a Senior Study Contract Manager! This is a hybrid role in the greater Toronto area.

The Senior Study Contract Manager (Sr.SCM) plays an important 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, institutions, or external vendors, ensuring ethical, fair, and compliant practices. Sr.SCM has regular communication with investigators, institutions, and other key external and internal stakeholders.

Responsibilities include:

1. Adapting global templates of agreements to local use in accordance with local requirements and SOPs.
2. Developing and negotiating clinical site budgets based on Fair Market Value.
3. Negotiating agreement language and budgets with clinical study sites.
4. Acting as the point of contact and interface with Legal when necessary to ensure integrity of contracts.
5. Maintaining the status of each agreement, including budgets, issues, payments, amendments, and communications during the study.
6. Ensuring final contract documents are consistent with negotiated agreements.
7. Ensuring all agreements are executed in a timely manner to support internal and external audits.
8. Ensuring compliance with the client’s Code of Conduct and company policies related to people, finance, technology, and security.
9. Including all contracts in the Trial Master File (TMF).
10. Training and mentoring new members of the local Study Team regarding financial and contractual issues.
11. Supporting the preparation and negotiation of a Local Master Service Agreement.
12. Contributing to process improvements, knowledge transfer, and sharing best practices.
13. Completing required training and timesheets accurately.
14. Submitting expense reports as required.
15. Updating CVs as needed.
16. Maintaining knowledge of and complying with Parexel processes, ICH-GCPs, and other applicable requirements.

Skills required include:

• Excellent attention to detail.
• Good written and verbal communication skills.
• Strong collaboration and interpersonal skills.
• Fluency in English and the host country language.

Knowledge and experience include:

• At least 2 years of experience in site contract negotiation or customization.
• Excellent knowledge of ICH-GCP guidelines and basic knowledge of GMP/GDP.
• Good understanding of relevant local regulations.
• Basic understanding of the drug development process.
• Understanding of Clinical Study Management including monitoring, drug handling, and data management.

Education:

• Bachelor’s degree in life sciences, law, finance, or an equivalent qualification.

Other requirements include the ability to travel nationally and internationally as needed.

EEO Disclaimer: Parexel is an equal opportunity employer. Qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.