Senior Study Contract Manager- FSP

Parexel; Ontario; Hybrid; CAD 80,000 - 110,000; Full time

Job summary

A leading company in the clinical research sector is seeking a Senior Study Contract Manager in Ontario. This hybrid role involves managing contracts and budgets for clinical trials, ensuring compliance with regulations, and mentoring team members. Candidates should possess a Bachelor's degree and have at least 2 years of relevant experience in contract negotiation.

Qualifications

• At least 2 years of experience in site contract negotiation/customization.
• Excellent knowledge of international guidelines ICH-GCP.
• Basic understanding of the drug development process.

Responsibilities

• Develops and negotiates clinical site budgets based on Fair Market Value.
• Maintains status of agreements, budgets, and communications.
• Ensures compliance with client’s Code of Conduct and company policies.

Skills

Attention to detail

Communication

Collaboration

Fluency in English

Fluency in host country language

Education

Bachelor’s degree in related discipline

Job description

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

Parexel is looking for a sponsor dedicated Sr Study Contract Manager!

This is a hybrid role with 3 days per week based in Mississauga Ontario Canada.

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

Key Accountabilities :

• Adapts global templates of agreements to local use in accordance with local requirements and SOPs.
• Develops and negotiate clinical site budgets based on Fair Market Value.
• Negotiates agreement language and budget with clinical study sites.
• Acts as point of contact and interface with Legal if necessary to ensure integrity of contracts.
• For each agreement maintains the status of agreement, budgets, issues, payments, any amendments for the duration of the study, and communications with internal and external sources.
• Ensures final contract documents are consistent with agreements reached at negotiations.
• Ensures all agreements are executed in a timely manner contributing to efficient site start-up timelines.
• Supports internal and external audits activities.
• Ensures compliance with client’s Code of Conduct and company policies and procedures relating to people, finance, technology, and security.
• Ensures that all contracts are included in the Trial Master File (TMF).
• Training and mentoring of new members of the local Study Team regarding financial / contractual issues and sharing experiences.
• Supports preparation and negotiation of a Local Master Service Agreement.
• Contributes to process improvements, knowledge transfer and best practice sharing.
• Complies with required training curriculum.
• Completes timesheets accurately as required.
• Submits expense reports as required.
• Updates CV as required.
• Maintains a working knowledge of and complies with Parexel processes, ICH-GCPs and other applicable requirements.

Skills :

• Excellent attention to details.
• Good written and verbal communication skills.
• Good collaboration and interpersonal skills.
• Read, write, and speak fluent English.
• Fluency in host country language required.

Knowledge and Experience :

• At least 2-year experience in site contract negotiation / customization.
• 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.

Education :

• Bachelor’s degree in related discipline, preferably in life science, law, finance, or equivalent qualification.

Other :

• Ability to travel nationally / internationally as required.

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