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Clinical Trial Manager Ii

7-9 years
Not Disclosed
10 May 16, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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