Accountabilities:

The Project Manager will oversee end-to-end feasibility and site activation activities, ensuring clinical studies are launched efficiently, compliantly, and within agreed timelines. The role requires strong ownership of start-up strategies, stakeholder coordination, risk management, and continuous improvement initiatives.

• Develop and execute Study Start-Up strategies for global and multi-country clinical studies, ensuring alignment with timelines, scope, and sponsor expectations.
• Lead the creation and implementation of comprehensive Study Start-Up Plans covering regulatory submissions, ethics approvals, contracts, and site activation milestones.
• Manage end-to-end site activation activities from site identification through activation and investigational product release.
• Provide strategic input during bid defense and study kick-off meetings to support feasibility planning and successful study execution.
• Oversee regulatory and ethics submission activities, ensuring accurate, compliant, and timely approvals across regions.
• Coordinate site contract and budget negotiations with sponsors, legal teams, finance teams, and site stakeholders.
• Identify operational risks, dependencies, and delays while implementing mitigation plans and escalation strategies.
• Partner with project managers and cross-functional teams to ensure seamless integration of start-up activities into overall study delivery.
• Maintain inspection readiness and ensure quality documentation through effective management of CTMS and eTMF activities.
• Lead and support Study Start-Up team members by providing guidance, coordination, and performance oversight.
• Monitor study metrics, budgets, scope of work, and delivery performance against agreed objectives.
• Drive process improvements and contribute to operational excellence initiatives across regions.
• Provide structured reporting, updates, and recommendations to sponsors and internal leadership teams.

Requirements:

The ideal candidate should have strong clinical research project management experience, particularly in Study Start-Up and site activation activities. Candidates should demonstrate excellent organizational skills, regulatory knowledge, and the ability to manage complex global studies.

• Proven experience managing Study Start-Up (SSU) activities as a primary responsibility, including ownership of site activation processes.
• Experience supporting global or multi-country clinical trials within a clinical research organization, pharmaceutical, or healthcare environment.
• Strong understanding of regulatory and ethics submission processes, including country authority, ethics committee, and clinical trial application strategies.
• Experience managing site contracts, budgets, and activation timelines.
• Demonstrated ability to manage competing priorities, project risks, dependencies, and critical milestones.
• Hands-on experience with clinical trial systems such as CTMS and eTMF.
• Strong knowledge of ICH-GCP guidelines and applicable clinical research regulations.
• Excellent stakeholder management skills with the ability to communicate effectively with sponsors, sites, and internal teams.
• Ability to work collaboratively across global, cross-functional teams.
• Structured, proactive, and solution-oriented approach to project delivery.
• Strong analytical, organizational, and problem-solving skills.
• Excellent written and verbal communication abilities.

Benefits:

• Competitive base salary and performance-based incentives.
• Comprehensive health and wellbeing programs, including medical coverage where applicable.
• Retirement and pension benefits.
• Life insurance and disability coverage.
• Employee assistance programs and wellbeing resources.
• Access to learning, development programs, and career growth opportunities.
• Opportunity to work on global clinical research projects with meaningful patient impact.
• Collaborative environment with exposure to international healthcare and research teams.
• Flexible work arrangements with office or home-based options depending on location.