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Clinical Trial Manager Ii

7-9 years
Not Disclosed
10 June 3, 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

 

Job Title:

Clinical Trial Manager II


Location:

Bengaluru (Bangalore), India


Job Type:

Regular Full-Time


Division:

Clinical Operations


Requisition Number:

2546


Company Overview:

Emmes Group is a leading clinical research organization with over 47 years of experience, specializing in cutting-edge medical research including cell and gene therapy, vaccines, infectious diseases, rare diseases, and neuroscience. Emmes values collaboration, innovation, and patient-focused research.


Primary Purpose:

The Clinical Trial Manager II (CTM II) will oversee operational activities for clinical trials at the regional or multi-country level. This includes managing clinical site monitoring, timelines, team leadership, and communication with sponsors and internal teams to ensure trial execution aligns with study protocols and regulatory standards.


Key Responsibilities:

  • Lead operational strategy and execution for assigned clinical trials.

  • Mentor and oversee Clinical Research Associates (CRAs) and site management teams.

  • Manage operational activities through all study phases, adhering to SOPs and client requirements.

  • Act as primary operational contact for clients and internal teams.

  • Lead study-related meetings and calls; escalate issues when necessary.

  • Develop and review critical study documents (Manual of Procedures, Clinical Monitoring Plan, SOPs, etc.).

  • Ensure compliance with site document currency, ethics approvals, and regulatory requirements.

  • Track and report site performance and study progress, identifying and mitigating risks proactively.

  • Collaborate closely with data management and safety teams.

  • Manage study supplies and investigational product accountability.

  • Support bid defense, proposals, and DSMB/DMC coordination as needed.


Qualifications:

  • Bachelor’s or Master’s degree in a science-related field.

  • 7-9 years of relevant clinical research experience, including CRA or clinical operations leadership roles.

  • Strong interpersonal, organizational, analytical, and communication skills.

  • Proficiency in MS Office.

  • Ability to prioritize, multitask, work independently and within cross-functional teams.

  • Knowledgeable of clinical research operations, regulations, and ICH guidelines.

  • Demonstrated problem-solving, planning, and collaboration skills.