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Director Clinical Research

Excelya
Excelya
2-4 years
Not Disclosed
10 Dec. 12, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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

General Responsibilities/Tasks:

  • Writing and updating clinical documents including abbreviated protocols, full protocols, informed consent forms (ICF), and amendments related to complex/pivotal clinical trials, particularly in immunology and inflammation.
  • Provide medical support for real-world data pressure testing and operational feasibility assessments.
  • Contribute to the preparation of responses to Health Authorities (HAs), Ethics Committees (ECs), clinical sites, and study teams (both global and local).
  • Participate in and help prepare for various meetings, such as those with investigators, monitors, and other key stakeholders.
  • Manage and contribute to the setup, development, and documentation of key committees, including:
    • Steering Committee: Liaise with selected members, set up meetings, develop the committee charter, and ensure proper documentation.
    • Data Monitoring Committee (DMC): Oversee the committee setup, member contacts, meeting coordination, and documentation.
    • Adjudication Committee: Ensure the committee setup, contact with members, and development of charters and meeting documentation.
  • Provide medical support, guidance, and training to the clinical study team, including CSO PL, GSM, biostatisticians, Medical Advisors, CPLs, and investigators, as well as CROs.
  • Contribute medical input to study plans, including CMP, MRP, SS reviews, and SRMP; assist with CRF design, CRF completion instructions, deviation lists, and management strategies.
  • Offer guidance and medical support for data reviews, statistical surveillance, coding, medical validation, and clinical case review material development.
  • Review clinical case profiles and validate narratives related to patient data.
  • Review and endorse the Statistical Analysis Plan.
  • Contribute to the preparation of key results and clinical study report sections.
  • Support preparation for audits and inspections, addressing any potential concerns related to clinical trials.
  • Assist with draft publication reviews and provide support for publication processes.
  • Prepare for audits and inspections and provide support to submission processes and the clinical development plan.

Minimum Requirements:

  • A Medical Doctor (MD) degree is required.
  • A minimum of 2-4 years of experience in clinical operations, including clinical trial design and document preparation (protocols, synopses, etc.).
  • Experience in participating in key committees such as the Data Monitoring Committee (DMC) and Drug Safety Committee.
  • Expertise in reviewing patient profiles and managing patient health issues.
  • Fluency in English, with strong document writing and communication skills in English.