Site Management Associate I

About the Company

We are a dynamic, global company founded in 1995, comprising over 3,200 dedicated professionals. We operate at the forefront of medical science, focused on changing lives and delivering new medicines to those in need. Our core values emphasize care for our staff, clients, partners, and the quality of our work.

Role: Site Management Support (Hybrid)

This hybrid role, based in Mississauga, ON, Canada, focuses on supporting clinical trial site management and operations. You will be a key point of contact and facilitator, ensuring efficient information flow, proper documentation, and effective coordination between sites, vendors, and internal departments.

Responsibilities:

Site Management:

• Facilitate the exchange of information and documentation with clinical trial sites and vendors.
• Oversee the order, receipt, inventory, storage, distribution, return/recall, and reconciliation of clinical supplies.
• Manage regulatory and ethics committee submissions and notifications.
• Ensure proper administration of site and vendor payments.
• Coordinate preparation for and follow-up on site, TMF, and systems' audits and inspections.
• Review and coordinate site-specific query resolution.
• Review and coordinate site-specific EDC completion, providing regular updates on status.

Other Communication:

• Exchange information and documentation with other departments.
• Support the organization of internal team meetings (agendas, minutes).
• Assist in organizing Investigator Meetings.
• Maintain study-specific and corporate tracking systems.
• Serve as the primary contact point for sites, vendors, study supplies, and access management.
• Ensure communication between sites and off-site facilities.

Training:

• Arrange and track initial and ongoing project training for site teams on vendor-related systems.
• Provide training on courier management and study supply ordering to site teams.

Document Management:

• Regularly review the TMF at site and country levels, filing pending documents.
• Prepare, distribute, and update Investigator Site Files (ISF) and ISF checklists.
• Provide Monitors with ISF documents for filing prior to monitoring visits.
• Review and check translation status.

Safety Management:

• Ensure proper safety information flow with investigative sites.

CTMS Management:

• Update CTMS with missing project information.
• Assist Monitors with prompt completion of subject event and site event information in CTMS.
• Help Monitors meet deadlines for site visits, visit reports, and visit letter dates in CTMS.
• Track the resolution status of site issues and action items in CTMS.

Vendor Management:

• Ensure pre-study testing (e.g., dummy scans, MRI/CT qualification questionnaires, test ECGs) of local site facilities is completed.
• Track vendor-related supplies (lab kits, ECG electrodes, CDs for scans, etc.) at the site level.

Qualifications:

• A college or university degree or an equivalent combination of education, training, and experience.
• Minimum of 2 years of experience in the clinical research industry, corporate, or academic environment with demonstrated administrative experience and technical skills.
• Basic proficiency in MS Word, MS Excel, MS Outlook, and MS PowerPoint.
• Basic typing skills in English (minimum 40 words per minute).
• Knowledge of applicable software and project-specific systems (following proper training).
• French proficiency is considered an asset.

Additional Information:

• All applicant information will be kept confidential according to EEO guidelines.