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Clinical Trial Project Manager

2+ years
Not Disclosed
10 Nov. 22, 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

Company Description

Katalyst Healthcares & Life Sciences is actively hiring entry-level candidates for various positions in contract research related to clinical trials involving drugs, biologics, and medical devices. We offer immediate job opportunities in Drug Safety, Pharmacovigilance, and Clinical Research, working in collaboration with university hospitals, pharmaceutical companies, and recruitment partners.


Job Description

Position: Clinical Data Review Specialist

As a Clinical Data Review Specialist, you will play a pivotal role in the data review team, working closely with physicians, clinical scientists, and internal teams. This position involves reviewing and interpreting medical and clinical trial data, ensuring compliance with regulatory standards, and contributing to the successful execution of clinical studies.


Responsibilities

  • Collaborate as a key member of the data review team and serve as a close partner to physicians and clinical scientists.
  • Independently manage tasks with guidance required only in complex situations.
  • Build relationships with internal stakeholders such as clinical project teams, operations, and data management.
  • Review and interpret clinical trial data, including eligibility, adverse events, dosing, and study termination.
  • Submit queries to data management, review site responses, and ensure quality data sign-offs.
  • Ensure all work is compliant with Safety, Health, and Environment (SHE) standards, as well as regulatory guidelines, ensuring studies are audit-ready.

Requirements

  • Oncology clinical experience within the pharmaceutical industry is essential, with a preference for experience in immune-therapy clinical trials.
  • Comprehensive project experience across Phases I–III drug development.
  • Proven expertise in managing and interpreting clinical trial results.
  • Previous experience as part of a data review team is desirable, emphasizing communication, customer focus, and collaborative work.
  • Adequate technical and disease area knowledge to confidently engage with internal and external partners.

Additional Information

All applicant information will remain confidential per EEO guidelines.