(Sr) Project Manager, Feasibility Site Activation

Own and execute Study Start-Up (SSU) strategies for global, multi-country clinical studies in alignment with timelines, scope, and sponsor expectations.

Lead comprehensive Study Start-Up Plans covering regulatory submissions, ethics requirements, and contract execution across participating countries.

Drive end-to-end start-up activities from site identification through Investigational Product (IP) release while maintaining accountability for critical milestones.

Provide strategic input during Bid Defense and Kick-Off meetings, influencing study design and start-up feasibility.

Oversee regulatory and ethics submissions to achieve high-quality, compliant, and timely approvals across regions.

Manage site contract and budget negotiations with legal, finance, sponsors, and sites to support timely activation.

Identify risks, dependencies, and bottlenecks and implement mitigation and escalation strategies to protect study timelines.

Partner with Project Managers and cross-functional stakeholders to integrate study start-up activities into overall clinical study delivery.

Ensure study documentation is accurate, complete, high quality, and inspection ready, including oversight of CTMS and eTMF activities.

Lead and coordinate Study Start-Up team members by providing direction, support, and operational oversight.

Drive process consistency and continuous improvement across regions and contribute to operational excellence initiatives.

Monitor study metrics, budgets, and scope of work (SOW) and ensure delivery within agreed parameters.

Provide structured reporting and status updates to sponsors and internal leadership to support informed decision-making.

End-to-end Study Start-Up and site activation ownership.

Global and multi-country clinical study start-up experience.

Regulatory and ethics submission processes, including CA/EC and CTA strategy.

Site contract and budget coordination and negotiation.

Understanding of ICH-GCP and applicable regulatory frameworks.

CTMS, eTMF, and other clinical trial system experience.

Manage complex SSU timelines, risks, dependencies, competing priorities, budgets, and scope.

Coordinate global cross-functional teams, sponsors, sites, and internal stakeholders.

Provide leadership and direction to Study Start-Up team members.

Maintain accountability for milestones and delivery quality.

Communicate effectively with sponsors and internal leadership.

Apply a structured, proactive, and solution-oriented approach to clinical study delivery.

Full-time position.

Office or Home work arrangement.

Locations include Bangalore, Trivandrum, and Chennai, India.

Employment is contingent upon having the legal right to work in the country where the role is based.

Competitive base salary and performance-related incentives.

Health and wellbeing programs, including medical, dental, and vision coverage where applicable.

Retirement and pension plans.

Life assurance and disability coverage.

Employee assistance programs and wellbeing resources.

Learning and development opportunities through structured training and career pathways.

Benefits may vary depending on role and location.

ICON is an equal opportunity employer committed to an inclusive and accessible workplace.

Reasonable accommodations are available during the recruitment process.