Site Activation Manager I (SAM I)
We are seeking a Site Activation Manager I (SAM I) to support the successful identification, start-up, and activation of clinical trial sites. This role serves as the functional lead for assigned site activation activities and works closely with Project Managers, Sponsors, Vendors, and cross-functional teams to ensure study milestones are achieved in accordance with quality, timeline, and budget expectations.
As part of a collaborative and site-focused environment, the SAM I will play an important role in ensuring clinical sites are prepared and activated efficiently, contributing directly to the successful delivery of clinical research programmes. This is an entry-level site activation management position that operates under the guidance and mentorship of a Senior Site Activation Manager.
Position Overview
Employment type: Contract
Length: 12 months with a view to extend
Hours: Full-time
Working Model: Remote
Key Responsibilities
- Coordinate site identification and feasibility activities, including Site Feasibility Questionnaires (SFQs) and Confidential Disclosure Agreements (CDAs).
- Develop and maintain site activation plans, timelines, trackers, and study start-up documentation.
- Prepare, distribute, review, and manage Essential Document Packages (EDPs) and regulatory documentation to ensure accuracy, completeness, and compliance.
- Manage site activation records and quality control activities within the Trial Master File (TMF).
- Support site contract, budget, and Central IRB processes.
- Track study start-up progress, identify risks and operational challenges, and escalate issues as appropriate.
- Serve as a key liaison between Sponsors, study sites, vendors, and internal project teams.
- Coordinate start-up meetings, maintain action and decision logs, and support study amendments as required.
- Ensure all site readiness requirements, including training, system access, study supplies, and regulatory approvals, are in place prior to Site Initiation Visits (SIVs).
- Monitor and report study start-up KPIs, site activation metrics, and lessons learned.
- Support quality assurance activities, audit readiness, audit responses, and process improvement initiatives, including SOP development.
Qualifications & Experience
- University degree in Life Sciences or a related discipline, or equivalent combination of education and experience.
- Minimum of two years experience within clinical research, pharmaceutical, CRO, sponsor, or site environments.
- Experience supporting clinical trial site start-up and activation activities.
Required Skills
- Working knowledge of ICH-GCP guidelines and applicable FDA, UK, and/or European regulations.
- Strong organisational skills with the ability to manage multiple priorities and critical timelines.
- Excellent verbal and written communication skills with a professional and client-focused approach.
- Ability to work effectively with stakeholders across all organisational levels.
- Sound judgement and problem-solving capabilities.
- Experience with regulatory document management and clinical trial start-up processes.
- Proficiency in Microsoft Office applications, including Word, Excel, and PowerPoint.
- Fluent English (written and spoken).
- Willingness to travel occasionally as required.
This opportunity is ideally suited to an early-career clinical operations professional seeking to develop expertise in site activation while contributing to the successful delivery of clinical studies within a high-performing and collaborative environment.
