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Manager, Clinical Operations-2407022599w

7+ years
Not Disclosed
10 Jan. 15, 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

Manager, Clinical Operations - Job ID 2407022599W

Location: Bangalore, India
Job Function: R&D

Kenvue is recruiting for a Manager, Clinical Operations to coordinate operational aspects of high-complexity clinical studies within India, APAC, or EMEA regions for Consumer Health products. This role will collaborate with global and local teams to ensure the execution of clinical studies in compliance with Good Clinical Practice (GCP) and local regulations.

Key Responsibilities:

  • Lead clinical study operations, including planning, execution, and closure of studies.
  • Serve as the primary contact for local R&D projects and contribute to pipeline planning.
  • Mentor junior team members and provide technical support to global study managers.
  • Manage external service providers (ESPs) including site selection, training, and compliance.
  • Ensure compliance with study protocols, timelines, budgets, and quality standards.
  • Monitor clinical trial progress, handle adverse event reporting, and manage Trial Master Files (TMF).
  • Review essential study documents and ensure they are aligned with regulatory requirements.
  • Oversee the development of reference safety materials and ensure product accountability.
  • Coordinate site activation, track study deliverables, and approve vendor invoices.

Qualifications:

  • Required:
    • Bachelor’s degree in a scientific or healthcare discipline.
    • Minimum of 7 years of clinical study management experience, with at least 2 years in a people/team management role.
    • Expertise in GCP, ICH guidelines, and clinical trial management systems (CTMS).
    • Proficiency in Microsoft Word, Excel, and PowerPoint.
    • Advanced English proficiency (spoken and written).
    • Strong organizational, problem-solving, and time management skills.
  • Desired:
    • Knowledge of cosmetic and drug regulations.
    • Experience in global drug clinical studies.

Benefits:

  • Competitive total rewards package.
  • Paid company holidays, vacation, volunteer time, and more.
  • Learning and development opportunities.
  • Employee resource groups.