
Project Manager
ICON plc
full-time
Posted on:
Location Type: Hybrid
Location: Bangalore • 🇮🇳 India
Visit company websiteJob Level
SeniorLead
Tech Stack
Google Cloud Platform
About the role
- Driving site activation: Leading and managing the successful activation of sites from identification to IP release across multiple countries and projects.
- Study start-up planning: Developing, implementing, and overseeing Study Start-Up Plans, including integration into the Project Management Plan and alignment with sponsor expectations.
- Stakeholder collaboration: Acting as the primary point of contact for sponsors and internal teams including Regulatory, Contracts, CTMs, and Site ID, ensuring transparency and alignment across functions.
- Regulatory & ethics submissions: Overseeing submissions to Regulatory Authorities, Ethics Committees (ECs), and other relevant bodies, ensuring timely and high-quality execution.
- ICF and document review: Managing the development, finalization, and review of Master and Country-Specific Subject Information Sheets/Informed Consent Forms (SIS/ICFs), as well as EU Clinical Trial Application forms (where applicable).
- Contract & budget management: Coordinating site contract and budget negotiations, tracking site activation costs, identifying out-of-scope activities, and supporting change order processes.
- Timeline management: Forecasting and tracking study timelines and deliverables, identifying potential roadblocks, and implementing proactive mitigation strategies.
- Team leadership: Leading cross-functional SSU teams across regions, mentoring junior staff, and contributing to team development and training initiatives.
- Reporting & communication: Preparing and delivering study metrics and regular updates to internal and external stakeholders, supporting client meetings and bid defenses.
- Quality & compliance: Ensuring compliance with ICON SOPs, ICH-GCP, and local regulatory requirements, with responsibility for documentation accuracy and audit readiness.
Requirements
- Minimum 8 years of experience in Study Start-Up activities, including global project oversight.
- Strong knowledge of EUCTR, ICH/GCP, and global regulatory requirements for site activation.
- Experience managing budgets, contracts, and timelines across multiple global studies.
- Excellent leadership, communication, and organizational skills with a proven ability to work cross-functionally.
- Hands-on experience coordinating with global and regional teams to ensure on-time site initiation.
- Previous client-facing experience including Bid Defense and Kick-Off Meetings is preferred.
- Ability to manage competing priorities and maintain attention to detail in a fast-paced environment.
Benefits
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family’s needs.
- Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
- Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
Study Start-Up planningRegulatory submissionsBudget managementContract negotiationTimeline managementDocument reviewProject ManagementStakeholder collaborationQuality complianceAudit readiness
Soft skills
LeadershipCommunicationOrganizational skillsCross-functional teamworkAttention to detailMentoringClient-facing experienceProactive problem-solvingTime managementAdaptability