Clinical Director of Scientific Operations

1 month ago

New York, New York, United States SciPro Inc. Full time
SciPro Inc. Clinical Scientist Opportunity

We are seeking a highly skilled Clinical Scientist to play a crucial role in scientific planning and collaboration with Clinical Research, Pharmacovigilance, and Clinical Operations teams in the execution of one or more clinical trials or significant components thereof.

This position offers the opportunity to showcase leadership, technical expertise, and scientific insight as part of a cross-functional clinical development team. The Clinical Scientist will be a key contributor to clinical science activities, including protocol development, study implementation, data analysis, and the reporting of results.

Key Responsibilities:

  • Lead specific aspects of the clinical and scientific execution of clinical protocols, including:
  • Serving as the lead clinical scientist on clinical trial teams.
  • Leading medical monitoring teams in the review and interpretation of clinical data and protocol deviations in collaboration with Clinical Research and Pharmacovigilance.
  • Collaborate cross-functionally in the development of protocols and related study materials, including Informed Consent Forms (ICFs) and amendments, in partnership with Clinical Operations to achieve study deliverables.
  • Ensure that Case Report Form (CRF) design supports data collection aligned with the protocol in collaboration with Clinical Data Management and Programming teams.
  • Monitor clinical data to ensure the quality, completeness, and integrity of trial conduct.
  • Provide mentorship and tactical guidance to other clinical scientists.
  • Assist with the generation, analysis, and presentation of clinical data, including contributing to manuscripts, abstracts, and oral presentations.
  • Apply analytical expertise to understand how program objectives and design impact data analysis and identify risks while designing mitigation strategies.
  • Promote consistent medical and clinical data review techniques across studies and programs.
  • Experienced with J Review and EDC Systems.

Qualifications:

  • A Bachelors degree with 10+ years of relevant experience or a Post Graduate Degree with 8+ years of relevant experience in clinical research, with a solid understanding of clinical trial design, execution, and regulatory requirements.
  • Thorough knowledge of clinical research regulatory requirements (e.g., GCP and ICH).
  • Ability to manage multiple competing priorities with effective planning, time management, and prioritization skills.
  • Strong analytical skills to interpret clinical trial data and draw insightful conclusions.
  • Proficient in proposing, designing, and executing clinical research and development studies and in authoring documents related to clinical trials, such as medical monitoring plans, statistical analysis plans (SAPs), informed consent forms, and clinical components of Clinical Study Reports (CSRs).
  • Ability to influence opinions and decisions of internal and external stakeholders and vendors across functional areas.
  • Proactive approach, strategic thinking, and leadership in driving clinical study goals.
  • Strong problem-solving, prioritization, conflict resolution, and critical thinking skills.
  • Exceptional communication, technical writing, and presentation skills.
  • Experience in oncology is preferred.

Hourly rate will be dependant on experience and contract type.

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