Contracts Analyst I

Sitero LLC•Markham, ON

3d•Hybrid

About The Position

The Contracts Analyst I will support the end-to-end management of site-level clinical trial agreements and related contractual documents. Working within the Legal / Contract Operations corporate function, this role plays a key part in enabling site activation by drafting, reviewing, and tracking Clinical Trial Agreements (CTAs), Confidentiality Agreements (CDAs), and ancillary site documents. This is an excellent opportunity for an early-career professional looking to grow within a dynamic CRO environment.

Requirements

Bachelor's degree in Life Sciences, Business Administration, Legal Studies, Health Sciences, or a related field required.
1–2 years of experience in contract management, clinical operations, or a related role within a CRO, pharmaceutical, biotech, or healthcare organization (or equivalent through internship/co-op experience).
Familiarity with clinical trial operations and the site activation process is a strong asset.
Understanding of clinical trial agreement structures and standard contract terminology.
Strong attention to detail, organizational skills, and ability to manage multiple contracts simultaneously.
Excellent written and verbal communication skills; comfortable negotiating with site administrators and legal representatives.

Nice To Haves

Experience with CTMS platforms (e.g., Veeva, Medidata, Oracle) and/or contract lifecycle management (CLM) software.
Knowledge of ICH-GCP guidelines and Health Canada regulatory requirements.
Experience with budget negotiation and FMV assessment tools.
Familiarity with CDA/NDA management workflows.
Paralegal certificate or coursework in contract law is an asset.

Responsibilities

Draft, review, and negotiate Clinical Trial Agreements (CTAs), Site Agreements, Confidentiality/Non-Disclosure Agreements, and related legal documents with investigative sites, academic medical centers, and research institutions.
Assess site-proposed contract redlines against approved sponsor/CRO templates, escalating non-standard language to legal counsel as appropriate.
Support budget reviews and negotiate site payment terms in alignment with Fair Market Value (FMV) guidelines and sponsor-approved budgets.
Maintain accurate contract status tracking in the CTMS and/or contract management system, ensuring milestone data is up to date and readily reportable.
Coordinate cross-functionally with Clinical Operations, Finance, and Regulatory teams to facilitate timely site activation.
Support KPI reporting on contract cycle times, site activation metrics, and outstanding negotiations.
Ensure all contractual activities comply with applicable regulations including ICH-GCP, Health Canada guidelines, FDA regulations, and company SOPs.
Assist in developing and refining contract templates, clause libraries, and process documentation.
Respond to site and sponsor inquiries regarding contract terms and payment schedules in a timely and professional manner.