Site Activation Manager

This is a fully remote position, open to applicants in Greece.

📋 Description

• Lead and oversee customer-centric Site Start-Up deliverables for assigned projects at the country, regional, or global level.

• Direct the technical and operational facets of Site Start-Up deliverables.

• Ensure that activation-ready study sites are delivered on schedule, within budget, and in compliance with relevant regulations.

• Supervise Site Start-Up activities from site selection and recommendations through to site activation readiness and the maintenance of the study life-cycle.

• Create Site Start-Up timelines and communicate progress, risks, and deficiencies to the project team, Project Manager, SSU Management, and Project Sponsor.

• Collaborate with Business Development, Alliance Management, Contracts and Proposals Development, SSU Country Managers, Project Management, Clinical, Data Management, and Medical Writing.

• Identify and assess Site Start-Up and regulatory pathway challenges, implementing solutions as necessary.

• Ensure that project deliverables align with internal and client expectations, including projections, reports, updates, risk identification, mitigation, and management.

• Build and maintain strong relationships with customers.

• Oversee site identification and selection, regulatory activities, clinical trial agreements, investigator budgets, essential document collection, and SSU timelines.

• Develop and manage comprehensive Site Start-Up timelines and report weekly updates.

• Present SSU strategy and status during client meetings and communicate outcomes effectively to project teams.

• Review SSU budgets, track project profitability, and implement corrective actions when necessary.

• Manage scope, timelines, resources, budgets, and any out-of-scope work.

• Prepare core submission documents and clinical trial application dossiers for amendments.

• Conduct Regulatory Impact Assessments and supervise risk mitigation and reviews.

• Assist in the development of Subject Information Sheets/Informed Consent Forms.

• Oversee the aggregation, quality review, and submission of country-specific applications.

• Contribute to SSU change initiatives.

• Submit relevant documents to the Trial Master File in accordance with company SOPs and sponsor requirements.

• Perform other assigned job-related duties.

⛳️ Requirements

• Bachelor’s Degree required; Higher Degree preferred.

• Strong understanding of the clinical trial process across Phases II-IV and ICH GCP.

• Good comprehension of clinical protocols and related study specifications.

• Excellent grasp of clinical trial start-up processes.

• Project management experience in a dynamic environment.

• Proficient vendor management capabilities.

• Strong organizational skills with a proven ability to manage multiple projects.

• Excellent communication, presentation, and interpersonal abilities.

• Quality-driven in all aspects of managed activities.

• Strong negotiation skills.

• Effective problem-solving abilities.

• Capacity to provide constructive feedback and guidance to peers.

• Equivalent experience, skills, and/or education will also be considered.

• Minimal travel may be required (up to 25%).

🏝️ Benefits

• Career development and progression opportunities.

• Supportive and engaged line management.

• Technical and therapeutic area training.

• Peer recognition initiatives.

• Comprehensive total rewards program.

• Inclusive workplace culture.

• Reasonable accommodations available when appropriate.