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Senior Manager, Clinical Scientist

3-5 years
Not Disclosed
10 Nov. 22, 2024
Job Description
Job Type: Full Time Education: MD degree in life sciences (mandatory) 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 Description

Position Summary

The selected candidate will be responsible for designing and executing assigned clinical trial activities while collaborating closely with the clinical team to ensure seamless execution. The role may include serving as the Clinical Trial Lead for one or more trials, supporting trial-level activities, and co-leading study team meetings in partnership with the GDO Protocol Manager. The candidate will also work collaboratively with cross-functional study team members to drive successful trial outcomes.

Responsibilities

Clinical Trial Execution

  • Design and execute assigned clinical trial activities with necessary supervision.
  • Lead or support trial-level activities for one or more trials.
  • Co-lead study team meetings and collaborate with cross-functional teams.
  • Develop and present Protocol and Informed Consent Form (ICF) documents/amendments to governance committees and development teams.

Collaboration and Reporting

  • Collaborate with external partners, including Key Opinion Leaders (KOLs).
  • Provide timely updates to managers and stakeholders.
  • Monitor clinical data for trends and insights.
  • Liaise with Data Management to develop a comprehensive Data Review Plan.

Documentation and Compliance

  • Submit clinical documents to Trial Master File (TMF).
  • Ensure the Case Report Form (CRF) design supports data collection aligned with the protocol.
  • Review and contribute to clinical narratives, study reports (CSRs), and regulatory documents (e.g., Investigator Brochure [IB], DSUR, PSUR, Orphan Annual Reports, Health Authority responses).
  • Conduct literature reviews to support clinical trial documentation.

Training and Development

  • Develop and deliver training materials for sites and Clinical Research Associates (CRAs) during Site Initiation Visits (SIVs) and Investigator meetings.
  • Identify and implement best practices under supervision.

Quality Assurance

  • Ensure compliance with Good Clinical Practice (GCP), ICH guidelines, and relevant regulatory standards.
  • Participate in regulatory submissions and audits.

Qualifications

  • Education: MD degree in life sciences (mandatory).
  • Experience:
    • Basic understanding of the drug development process, study design, and clinical operations.
    • Intermediate knowledge of medical writing, medical terminology, and regulatory compliance.
    • Oncology and Hematology exposure is compulsory.
  • Skills:
    • Strong knowledge of GCP/ICH guidelines.
    • Basic to intermediate planning/project management skills.
    • Ability to understand protocol requirements and identify data trends.
    • Excellent communication, presentation, and interpersonal skills.
    • Proficient in developing realistic short-range plans.