Clinical Medical Scientist – Medical Monitoring, Infectious Disease

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

📋 Description

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

• Facilitate the gathering of medical and scientific insights from external experts, consultants, and advisors.

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

• Evaluate data to pinpoint risks and trends, while documenting medical reviews accordingly.

• Identify and address issues related to medical data reviews.

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

• Support patient profile evaluations, scientific assessments of study-level data, protocol deviation reviews, and Medical Review Summary reports.

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

• Oversee project scope, objectives, deliverable quality, milestones, and timelines.

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

• Work alongside Clinical Operations, Data Management, Drug Safety and Pharmacovigilance, and Project Management teams to identify risks to data integrity and subject safety.

• Raise study-related concerns, at-risk deliverables, and out-of-scope tasks to project leaders.

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

• Maintain a comprehensive understanding of protocol designs, disease terminology, and pathology.

• Adhere to data privacy regulations, ICH, GCPs, company policies, SOPs, work instructions, and project plans.

⛳️ Requirements

• A degree in life sciences (BS, MSc, PharmD, PhD) is required.

• Prior medical monitoring experience in HIV clinical trials is mandatory.

• Exceptional time management skills to juggle multiple tasks and adhere to deadlines in a highly regulated and dynamic setting.

• A self-starter who is comfortable with changing timelines, work demands, and scope alterations.

• Capability to troubleshoot issues and escalate concerns or inquiries as necessary.

• Understanding of scientific principles for effective and high-quality medical data analysis.

• Strong written and verbal communication skills.

• Proficient computer skills, including MS Office applications, spreadsheets, and presentation software.

• Familiarity with drug development and proven expertise in ICH/GCP guidelines.

• Strong interpersonal skills and the ability to collaborate effectively in a cross-functional team environment.

• Willingness to travel up to 25%.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged management.

• Technical and therapeutic area training.

• Peer recognition and comprehensive rewards program.

• Medical, dental, and vision health benefits.

• Company-matched 401k plan.

• Eligibility to join the Employee Stock Purchase Plan.

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

• Flexible paid time off (PTO) and sick leave.

• Company car or car allowance may be provided.