Clinical Scientist, Medical Monitoring – Oncology, Multi-Indication

This is a fully remote position, open to applicants in United States.

📋 Description

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

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

• Conduct routine and on-demand medical reviews of data listings and visual representations of data.

• Analyze data to detect risks, patterns, and trends while supporting the documentation of medical reviews.

• Draft medical data queries, evaluate the responses, and approve the closure of queries in conjunction with the Medical Director.

• Assist in reviewing patient profiles, performing scientific evaluations of study-level data, assessing protocol deviations, and compiling Medical Review Summary reports.

• Collaborate with Medical Directors during medical data review and safety assessment meetings, including preparing presentation materials.

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

• Act as the main point of contact among internal teams, clients, and vendors for medical data and eligibility evaluations.

• Work in tandem with study teams to pinpoint risks related to data integrity and subject safety.

• Raise project issues, deliverables at risk, and tasks that fall outside the defined scope to project leads.

• Participate in Trusted Process meetings and engage in both internal and external audits.

• Comply with relevant data privacy regulations, ICH, GCP, and the requirements set by the company, customers, and projects.

⛳️ Requirements

• Familiarity with current protocol designs and terminology related to diseases and pathology.

• Commitment to data privacy regulations, International Committee on Harmonization (ICH), and Good Clinical Practices (GCPs).

• Compliance with enterprise and customer policies, standard operating procedures, work instructions, and project plans.

• Equivalent experience, skills, and/or education may also be taken into account.

• Proficiency in handling medical data reviews, eligibility assessments, data listings, and data visualizations.

• Capability to compose medical data queries and evaluate query responses.

• Ability to work collaboratively with Clinical Operations, Data Management, Drug Safety and Pharmacovigilance, and Project Management teams.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged management team.

• Training in technical and therapeutic areas.

• Recognition among peers and a comprehensive rewards program.

• Provision of a company car or car allowance.

• Medical, Dental, and Vision health benefits.

• 401k with company matching.

• Eligibility to enroll in the Employee Stock Purchase Plan.

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

• Flexible paid time off (PTO).

• Sick leave.

• Reasonable accommodations provided when appropriate.