Clinical/Medical Scientist – Oncology – GI

This is a fully remote position, open to applicants in New York.

📋 Description

• Collaborate with the Medical Director to create Medical Management, Medical Data Review, and Eligibility Review Plans.

• Engage with external experts, consultants, and advisors to gather medical/scientific insights for medical plans.

• Conduct regular and ad-hoc reviews of data listings and data visualization from a medical perspective.

• Analyze data to pinpoint risks and detect data patterns/trends while documenting medical reviews.

• Identify and address issues related to medical data reviews.

• Draft medical data queries, assess responses, and authorize query closures in conjunction with the Medical Director.

• Assist in reviewing patient profiles, conducting scientific assessments of study-level data, examining protocol deviations, and preparing Medical Review Summary reports.

• Collaborate with Medical Directors during medical data review and safety review meetings, including preparation of presentations.

• Oversee project scope, objectives, the quality of deliverables, milestones, and timelines.

• Act as the primary liaison between internal teams, clients, and vendors for medical data and eligibility reviews.

• Work alongside study team members to identify risks concerning data integrity and subject safety.

• Raise study concerns, at-risk deliverables, and tasks that fall outside the project scope to project leads.

• Attend and present at Trusted Process meetings and engage in both internal and external audits.

• Comply with data privacy regulations, ICH, GCPs, enterprise policies, SOPs, work instructions, and project plans.

• Supervise a limited number of direct reports and take part in or conduct interviews.

⛳️ Requirements

• Proven experience and extensive knowledge in clinical/medical science and drug development.

• Fundamental understanding of current protocol designs.

• Basic knowledge of disease-related terminology and pathology.

• Familiarity with medical data review and eligibility review processes.

• Understanding of data listings and data visualization techniques.

• Capability to analyze data for identifying risks and recognizing data patterns/trends.

• Awareness of International Committee on Harmonization (ICH) guidelines and Good Clinical Practices (GCPs).

• Ability to comply with data privacy regulations, enterprise policies, standard operating procedures, work instructions, and project plans.

• Proficiency in collaborating with Clinical Operations, Data Management, Drug Safety, Pharmacovigilance, and Project Management teams.

• Competence to engage in or conduct interviews.

• Equivalent experience, skills, and/or education will also be considered.

🏝️ Benefits

• Opportunities for career growth and advancement.

• Supportive and engaged management team.

• Comprehensive training in technical and therapeutic areas.

• Recognition programs for peers and a total rewards system.

• A culture that embraces inclusivity.

• Company car or car allowance provided.

• Health benefits including Medical, Dental, and Vision coverage.

• Company-matched 401k plan.

• Eligibility to participate in the Employee Stock Purchase Plan.

• Opportunity to earn commissions and bonuses based on both company and individual performance.

• Flexible paid time off (PTO) policy.

• Sick leave provisions.