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Manager - Clinical Trial Transparency

5+ years
Not Disclosed
10 Feb. 4, 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 Trial Transparency

Location: Bangalore, India
Position: Full-time
Deadline: February 20, 2025

Job Description:

ICON plc is seeking a Manager, Clinical Trial Transparency to lead and establish processes ensuring compliance and ethical transparency in clinical trial data. This role is critical in ensuring the proper redaction and anonymization of clinical trial documents, including personal data and confidential information, according to regulatory requirements. You will play a pivotal role in managing cross-functional teams, overseeing clinical data transparency submissions, and maintaining high-quality, timely deliverables.

Key Responsibilities:

  • Lead redaction/anonymization activities for clinical trial documents, ensuring compliance with applicable laws and guidelines.
  • Develop and maintain commercial confidential information (CCI) strategy, collaborating with content experts.
  • Organize kick-off meetings for clinical data transparency submissions and train teams on processes and guidelines.
  • Coordinate cross-functional teams, track progress, and manage vendor interactions for submission documents.
  • Maintain personal data redaction guidelines and ensure updates according to regulatory authority requirements.
  • Provide document management expertise for redaction/anonymization and translation validation processes.
  • Collaborate with Health Authorities and regulatory teams as needed.
  • Train and mentor new colleagues.

Qualifications:

  • Education: Bachelor's degree required; advanced degree preferred.
  • Experience: Minimum 5 years in the pharmaceutical industry.
  • Strong verbal and written communication skills in English.
  • Proficient in electronic document management and IT tools, with a willingness to implement new systems.
  • Experience in project management, process development, vendor management, and coordination.
  • Ability to work independently and collaborate effectively in teams at all hierarchy levels.

Benefits:

  • Competitive salary and benefits package.
  • Various annual leave entitlements.
  • Health insurance options for you and your family.
  • Retirement planning offerings.
  • Employee Assistance Program with 24-hour support.
  • Flexible benefits, including childcare vouchers, gym memberships, and travel discounts.

About ICON:

ICON is a leading clinical research organization that helps deliver new medicines and medical devices benefiting patients worldwide. They offer a diverse and inclusive workplace that fosters innovation and supports a sustainable future.