Senior Manager – Clinical Scientist – Data Review

Senior Manager – Clinical Scientist – Data Review

Requirements

• 6+ years of experience with a Post Graduate Degree or 8+ years of experience with a Bachelor’s degree in a relevant scientific discipline.
• Solid knowledge of clinical research regulatory requirements (e.g., GCP and ICH).
• Strong analytical skills with the ability to interpret clinical trial data and synthesize conclusions.
• Proficient scientific expertise to propose, design, and execute clinical research and development studies, and authors documents related to clinical trials, such as medical monitoring plan, SAPs, informed consent and clinical components of the Clinical Study Reports.
• Ability to manage multiple competing priorities with good planning, time management and prioritization skills.
• Strong communication, technical writing, and presentation skills experience.

Responsibilities

• Responsible for supporting specific aspects of clinical/scientific execution of clinical protocol(s).
• Serving as a supportive clinical scientist data reviewer focused on safety, efficacy and critical data deliveries as part of the clinical trial team.
• Supporting the clinical study team as part of the clinical sciences functional line which is closely aligned with the medical monitoring team in review and interpretation of clinical data/medical protocol deviations in collaboration with Clinical Research and Pharmacovigilance (as well as other functional areas in this matrix environment).
• Collaborating cross-functionally in the development of Protocol and related study materials (e.g., ICF documents / amendments); partnering with Clinical Operations on critical and key study deliverables.
• Ensure CRF design supports data collection in alignment with the Protocol in collaboration with Clinical Data Management/Programming.
• Collaborating cross-functionally to review clinical data to ensure quality, completeness, and integrity of trial conduct.
• Potential to provide tactical/scientific mentorship to other clinical scientists and move into Clinical Scientist lead role as well as focus on scientific growth and development.
• Responsible for assisting with the generation, analysis, and presentation of clinical data, including manuscripts, abstracts, and oral presentations (including authoring documents and slide preparation as appropriate).
• Apply proficient analytical knowledge and skills to understand how program objectives and design impact data analysis; identifies risks and designs mitigation strategies.
• Promotes consistent first line medical/clinical data review techniques and conventions across studies/programs.

Preferred Qualifications

• Experience in clinical drug development experience, or a PhD, Pharm D, or RN degree is preferred.
• Experience within oncology preferred.