Clinical Scientist – Medical Monitoring, Infectious Disease, HIV

This is a fully remote position, open to applicants in Alabama, +36 more states.

📋 Description

• Collaborate with the Medical Director to formulate medical plans, which encompass Medical Management, Medical Data Review, and Eligibility Review Plans.

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

• Conduct routine and ad-hoc medical assessments of data listings and visual representations.

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

• Actively identify and address issues related to medical data reviews.

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

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

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

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

• Act as the primary liaison among internal teams, clients, and vendors regarding medical data and eligibility assessments.

• Work alongside Clinical Operations, Data Management, Drug Safety and Pharmacovigilance, and Project Management teams.

• Identify and escalate potential risks concerning data integrity, subject safety, project deliverables, and tasks that fall outside the project's scope.

• Ensure compliance with data privacy regulations, ICH, GCPs, organizational policies, customer procedures, work instructions, and project plans.

⛳️ Requirements

• Medical/scientific expertise pertinent to medical monitoring and infectious diseases/HIV.

• Proven experience in medical review of data listings and data visualizations.

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

• Experience in authoring medical data queries and assessing query responses.

• Familiarity with patient profile reviews, scientific evaluations of study-level data, and protocol deviation reviews.

• Knowledge of protocol designs and terminology related to diseases and pathology.

• Understanding of data privacy regulations, ICH, and GCPs.

• Commitment to adhering to organizational and client policies, standard operating procedures, work instructions, and project plans.

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

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged management team.

• Technical training and education in therapeutic areas.

• Peer recognition and comprehensive rewards program.

• Commitment to an inclusive workplace culture.

• Provision of a company car or car allowance.

• Access to medical, dental, and vision health benefits.

• Company-matched 401(k) plan.

• Eligibility to participate in the Employee Stock Purchase Plan.

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

• Flexible paid time off (PTO).

• Sick leave.

• Reasonable accommodations provided when appropriate.