Site Engagement Lead – Fortrea
Location
Bangalore, India
Job Type
Full-time
Experience Required
2–6 years of experience in Clinical Research, Clinical Monitoring, Clinical Operations, or Project Management.
Prior experience as a Clinical Research Associate (CRA), Clinical Trial Lead, or Clinical Project Coordinator is highly preferred.
Estimated Salary Package (Market Standard)
₹15 – ₹24 LPA (approx.), depending on experience, project management expertise, and interview performance.
Job Overview
The Site Engagement Lead (Clinical Team Lead – CTL) is responsible for leading the clinical delivery of clinical research trials. The role functions as the Clinical Project Manager (CPM), partnering with Project Managers and cross-functional teams to ensure successful execution of clinical studies while meeting timelines, quality standards, budget, and regulatory requirements.
Key Responsibilities
Clinical Project Management
Lead the clinical delivery of assigned clinical research studies.
Develop and execute clinical project strategies.
Ensure project milestones, timelines, quality, and contractual deliverables are achieved.
Manage project scope, resources, and budgets.
Monitor project performance using data-driven decision-making.
Site & Clinical Operations
Oversee site management and clinical monitoring activities.
Support subject recruitment and patient retention strategies.
Manage monitoring visit strategies and vendor performance.
Ensure compliance with protocol, SOPs, ICH-GCP, and regulatory requirements.
Participate in regulatory and ethics committee submissions when required.
Risk & Quality Management
Identify operational, financial, and quality risks.
Develop and implement proactive risk mitigation plans.
Apply Quality by Design (QbD) principles to project execution.
Ensure project audit and inspection readiness.
Manage issue escalation and corrective actions.
Client & Stakeholder Management
Serve as the primary clinical representative for assigned clients.
Build strong relationships with sponsors and cross-functional teams.
Lead project meetings and provide project status updates.
Support bid defense meetings, proposals, and business development activities.
Present project updates to internal and external stakeholders.
Financial & Resource Management
Monitor project budgets and financial milestones.
Forecast clinical project revenue and manage project costs.
Lead change order management and scope modifications.
Ensure accurate clinical resource planning and utilization.
Leadership & Team Development
Lead and mentor clinical project team members.
Promote collaboration across global, cross-functional teams.
Support performance development and provide constructive feedback.
Encourage continuous improvement and operational excellence.
Educational Qualification
Bachelor's degree in Life Sciences (preferred), Pharmacy, Nursing, Medical Sciences, Biotechnology, or a related healthcare discipline.
Allied health certifications (e.g., Nursing or Medical Laboratory Technology) are also acceptable.
Master's degree or PMP certification is an added advantage.
Equivalent relevant experience may be considered.
Required Skills
Strong understanding of ICH-GCP guidelines and international clinical research regulations.
Experience in Clinical Operations, Clinical Monitoring, or Clinical Project Management.
Excellent leadership, stakeholder management, and communication skills.
Strong project planning, organizational, and time management abilities.
Knowledge of risk management and quality management principles.
Financial awareness with experience managing project budgets.
Ability to manage multiple projects in a matrix environment.
Proficiency in Microsoft Office (Word, Excel, PowerPoint, Project, Access).
Strong analytical, decision-making, and problem-solving skills.
Ability to mentor junior team members and lead cross-functional teams.
Preferred Qualifications
Master's degree in Life Sciences or a related field.
PMP (Project Management Professional) certification.
2+ years of Clinical Research Associate (CRA) experience (on-site or in-house).
3+ years of clinical research experience in a Pharmaceutical, CRO, or Healthcare organization.
Experience in client-facing roles and bid defense presentations.
Work Environment
Office-based or remote work environment.
May require weekend or after-hours support based on project needs.
Up to 30% domestic and international travel.
Who Should Apply
Experienced Clinical Research Associates (CRA II/Senior CRA), Clinical Trial Leads, Clinical Project Coordinators, and Clinical Operations professionals looking to transition into clinical project leadership roles.
Professionals with strong experience in site management, stakeholder engagement, clinical operations, and project delivery within CROs or pharmaceutical organizations.
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