Site Activation Manager

AL Solutions; United States; Remote; AUD 90,000 - 120,000; Part time

Job summary

AL Solutions is seeking a Site Activation Manager I to support the successful identification, start-up, and activation of clinical trial sites. You will work as the functional lead for site activation activities, collaborating with Project Managers, Sponsors, Vendors, and cross-functional teams to achieve milestones.

This is an entry-level role under the mentorship of a Senior Site Activation Manager, with a 12-month contract, full-time hours, and a remote working model.

Qualifications

• University degree in Life Sciences or related discipline, or equivalent 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.

Responsibilities

• Coordinate site identification and feasibility activities (SFQs, 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.
• Manage site activation records and quality control within the TMF.
• Support site contract, budget, and Central IRB processes.
• Track start-up progress, identify risks, and elevate issues.
• Serve as liaison between Sponsors, sites, vendors, and internal teams.
• Coordinate start-up meetings and support amendments as required.
• Ensure readiness requirements prior to SIVs.
• Monitor and report start-up KPIs and lessons learned.
• Support QA activities, audits, and SOP enhancements.

Skills

ICH-GCP

Organisational skills

Communication

Stakeholder management

Regulatory documents

MS Office

English fluency

Travel willingness

Education

Bachelor's degree in Life Sciences

Job description

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 elevate 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.