Project Manager – Clinical Trials
Company: CLINEXEL – Full Service CRO
Location: Navi Mumbai, Maharashtra, India
Work Mode: 100% Office-Based
Employment Type: Full-Time
About CLINEXEL
CLINEXEL is a trusted Full-Service Contract Research Organization (CRO) conducting Phase I, Phase II, and Phase III clinical trials across India and global markets. We are committed to delivering high-quality clinical research solutions while maintaining the highest standards of scientific excellence, regulatory compliance, and patient safety.
Position Overview
We are seeking an experienced Project Manager – Clinical Trials to lead and manage clinical research projects from study start-up through study closure. The successful candidate will be responsible for ensuring project timelines, budgets, quality standards, and regulatory requirements are met while serving as the primary liaison between sponsors, study sites, vendors, and internal teams.
Key Responsibilities
Clinical Trial Project Management
Lead the planning, execution, monitoring, and completion of clinical trial projects.
Develop and manage project timelines, budgets, resource plans, and deliverables.
Ensure studies are conducted in accordance with study protocols, ICH-GCP guidelines, SOPs, and applicable regulatory requirements.
Sponsor & Stakeholder Management
Serve as the primary point of contact for sponsors and key stakeholders.
Conduct regular project meetings and provide status updates.
Build and maintain strong relationships with sponsors, investigators, vendors, and cross-functional teams.
Study Oversight & Coordination
Oversee study start-up, site activation, enrollment, monitoring, and close-out activities.
Track project milestones and proactively identify risks and mitigation strategies.
Ensure timely resolution of study-related issues and escalations.
Vendor & Site Management
Coordinate with CRO partners, laboratories, and external vendors.
Monitor vendor performance and ensure contractual deliverables are achieved.
Support investigator site management and operational oversight.
Quality & Compliance
Ensure compliance with ICH-GCP, regulatory requirements, and company SOPs.
Support audit and inspection readiness activities.
Review essential study documentation and maintain quality standards throughout the project lifecycle.
Financial & Resource Management
Monitor project budgets and resource utilization.
Track project financial performance and forecast project requirements.
Ensure efficient allocation of resources across study activities.
Required Qualifications
Bachelor's or Master's degree in Life Sciences, Pharmacy, Clinical Research, Biotechnology, or a related field.
Relevant experience in the Pharmaceutical, Biotechnology, or CRO industry.
Strong understanding of clinical trial processes and drug development.
Experience managing clinical research projects and cross-functional teams.
Knowledge of ICH-GCP guidelines and global regulatory requirements.
Excellent project management, communication, and leadership skills.
Uttar Pradesh :
Agra | Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | kanpur | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Gujarat :
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Remote, India | Siliguri |Illinois :
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Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Istanbul | Turkey |Norway :
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Brinny | Ringaskiddy |Carlow :
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Cork | Dublin | Limerick | Waterford |Ulster :
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China | Quarry Bay |Liaoning :
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Leiden |Netherlands :
Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
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South Yarra |United Kingdom :
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Witney |Ontario :
Australia | Richmond Hill | Uxbridge | North York | Renfrew | Mississauga |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Peru | Argentina |Brazil :
Sao paulo | Brazil |Attica :
Koropi | Athens |Greece :
Greece |North Island :
Auckland |New Zealand :
New Zealand |Austria :
Austria |Vienna :
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Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
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Tallinn |Hà Nội :
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Jakarta |East Java :
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Turku |Remote Korea :
Remote Korea |Republic of Korea :
Seoul |Kazakhstan :
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Bangkok |Israel :
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