Clinical/Medical Scientist – Oncology – Breast

This is a fully remote position, open to applicants in Alabama, +39 more states.

📋 Description

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

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

• Conduct regular and ad-hoc reviews of data listings and visualizations.

• Analyze data to uncover risks, patterns, and trends, while documenting the findings from medical reviews.

• Identify and address issues related to medical data reviews.

• Compose medical data queries, evaluate responses, and finalize query closures in conjunction with the Medical Director.

• Support patient profile assessments, conduct scientific reviews of study-level data, evaluate protocol deviations, and prepare Medical Review Summary reports.

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

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

• Act as the main point of contact between internal teams, clients, and vendors regarding medical data and eligibility review.

• Work alongside study teams to identify risks connected to data integrity and participant safety.

• Raise concerns about project deliverable risks and tasks that fall outside the project scope to project leads.

• Participate in and present at Trusted Process meetings, and engage in internal and external audits.

• Follow data privacy regulations, ICH guidelines, GCPs, enterprise policies, standard operating procedures, work instructions, project plans, and customer protocols.

• Supervise a small number of direct reports and take part in or lead interviews.

⛳️ Requirements

• Medical/scientific knowledge pertinent to oncology and breast cancer.

• Familiarity with protocol designs, disease-related terminology, and pathology.

• Comprehension of data privacy regulations, ICH guidelines, and GCPs.

• Capability to perform medical reviews of data listings and visualizations.

• Proficiency in analyzing data to detect risks and identify patterns or trends.

• Skill in drafting medical data queries and evaluating query responses.

• Ability to assess patient profiles and study-level data.

• Competence in reviewing protocol deviations and generating Medical Review Summary reports.

• Collaboration skills with Clinical Operations, Data Management, Drug Safety and Pharmacovigilance, and Project Management teams.

• Willingness to attend Trusted Process meetings and partake in internal and external audits.

• Proficiency in managing project scope, objectives, quality of deliverables, milestones, and timelines.

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

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged management.

• Training in technical and therapeutic areas.

• Peer recognition and a comprehensive rewards program.

• An inclusive work culture.

• Company-provided vehicle or vehicle allowance.

• Medical, Dental, and Vision health benefits.

• 401k with company matching.

• Eligibility to enroll in the Employee Stock Purchase Plan.

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

• Flexible paid time off (PTO).

• Sick leave.