Clinical Trial Manager II
Position Title:
Clinical Trial Manager II
Location:
India – Bengaluru
Department:
Clinical Operations
Employment Type:
Regular Full-Time
Company Overview:
Emmes Group is redefining the future of clinical research with a legacy of over 47 years. Known for pioneering clinical trials for the US government, Emmes has grown into a key player in public-private partnerships and commercial biopharma. The organization holds expertise in:
Cell and gene therapy
Vaccines and infectious diseases
Ophthalmology
Rare diseases
Neuroscience
Emmes fosters a collaborative, performance- and people-driven culture with a clear focus on innovation and patient impact.
Primary Purpose:
The Clinical Trial Manager (CTM) II oversees the operational execution of clinical studies across specific regions or country groups. This role involves leading monitoring teams, ensuring protocol compliance, maintaining trial timelines, and managing site performance and communications.
Key Responsibilities:
Design operational strategy aligned with protocol and timeline goals
Lead and mentor CRAs and site management staff
Drive study implementation phases, maintaining adherence to SOPs and project plans
Manage internal and external communications, escalating issues as necessary
Serve as client-facing contact for all operational activities
Lead and participate in operational meetings and calls
Develop and review study plans (e.g., Clinical Monitoring Plan, SOPs, TMF plans)
Oversee development of participant-facing materials and regulatory documents
Ensure timely submissions, data collection, and protocol adherence by CRAs
Recommend process improvements for compliance and quality enhancement
Maintain and report site performance metrics and identify potential risks
Coordinate with data systems, vendors, safety monitors, and supply chains
Oversee adverse event tracking and follow-up
Participate in bids, RFPs, and DSMB/DMC coordination
Perform training/co-monitoring visits and support document archiving
Qualifications:
Education:
Bachelor's degree required
Master’s degree (science-related field) preferred
Experience:
7–9 years in clinical research, including CRA or leadership roles
Skills & Competencies:
Team leadership, problem-solving, and critical thinking
Expertise in ICH guidelines and country-specific regulations
Excellent communication (written and oral)
Strong organizational, analytical, and prioritization abilities
Proficiency in MS Office Suite
Detail-oriented and capable of managing multiple projects independently
Additional Information:
Shift Work: No
Requisition ID: 2546
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | surat | Tarasadi | Vadodara | Vapi |Maharashtra :
Airoli | Ambernath | Amravati | Aurangabad | Dhule | Dombivali | Jalgaon | Kolhapur | Kurkumbh | Kurla | Madhapur | Mumbai | Nagpur | Nashik | Navi Mumbai | Pune | Pune city | Shirpur | Tandalja | Tarapur | Thane | Vikhroli | Yerawada |Haryana :
Ambala | Gurugram | Haryana | Hisar | Kurukshetra | Panchkula | Rohtak | Shivalik |Andra Pradesh :
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Baddi | Solan |Rajasthan :
Banasthali | Bhiwadi | Jaipur | Pilani | Udaipur |Karnataka :
Bangalore | Belgaum | Bengaluru | B.G Nagara | Bommasandra | Colorado | Czech Republic | Karnataka | Mangaluru | Mysore | Udupi |Punjab :
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Japan | Saitama |Tokyo :
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