The Site Contract Specialist will be responsible for the execution, negotiation and administration of assigned site contracts and supporting documents including, confidentiality agreements, clinical trial agreements, letters of indemnity and authorization. The incumbent will coordinate with sites, sponsors, vendors and internal stakeholders to facilitate the timely execution of contracts in accordance with project, corporate, industry and regulatory best practices and guidelines. Provide training on internal site contract processes and some mentoring of department staff. Support the department and company in achieving objectives and strategic goals.
Site Contract Management and Execution
- Coordinate the review and negotiation of new site contracts and amendments and secure the approvals from internal stakeholders, sponsors, and clinical trial sites, required for the execution of contracts and supporting documents on a timely basis.
- Ensure all work and final documents [including storage of] align with SOP's and project protocols, corporate, industry and regulatory standards and legal best practices. Engage the services/guidance of outside legal counsel as required.
Ongoing Site Contract Process Development
- Support Manager, Contracts & Compliance in developing site contracting processes and policies.
- Assist Manager, Contracts & Compliance in the creation and ongoing maintenance of site agreement templates.
- Act as an escalation point for Contract Coordinators for legal or process questions arising in site contracts.
Corporate Contract Services Support
- Provide support to the Legal team in the review and execution of corporate contracts including project orders, change orders and confidentiality agreements, particularly those related to full-service projects.
Qualifications
- MINIMUM EXPERIENCE REQUIREMENTS: 1 - 3 years of related experience, post-secondary certificate / diploma (College, Training Institute, etc.)
- PREFERRED EXPERIENCE REQUIREMENTS: 4 - 6 years of related experience, (Honors) bachelor’s degree
- LANGUAGE REQUIREMENTS: High level of fluency in written English to facilitate contract negotiations; Knowledge of other languages (e.g. Polish, Hungarian, Spanish, French, Italian) is an asset
Additional Knowledge/Skills
- Preferred legal-related diploma, degree, designation or paralegal certificate.
- Contract management and negotiation experience is required, preferably within the pharmaceutical, biotechnology, or contract research organization (CRO) industry
- Experience with clinical trial agreements and site contracts preferred.
Working conditions
- Home based
- *Accommodations for job applicants with disabilities are available upon request.
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