Clinical Scientist – Medical Monitoring, Neuroscience

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

📋 Description

• Collaborate with the Medical Director to formulate medical plans and gather essential medical/scientific input from external experts, consultants, and advisors.

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

• Analyze data to detect risks and discern patterns/trends, while documenting medical assessments.

• Create medical data queries, review the corresponding responses, and approve query closure in conjunction with the Medical Director.

• Support patient profile evaluations, scientific assessments of study-level data, protocol deviation analyses, and the preparation of 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 main point of contact between internal teams, clients, and vendors for medical data and eligibility reviews.

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

• Communicate study concerns, at-risk deliverables, and tasks outside the defined scope to project leads.

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

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

⛳️ Requirements

• Capability to develop medical plans with the Medical Director, including the Medical Management Plan, Medical Data Review Plan, and Eligibility Review Plan.

• Proficiency in conducting medical reviews of data listings and visualizations, while identifying risks and data patterns/trends.

• Skill in creating medical data queries, reviewing responses, and approving query closure in collaboration with the Medical Director.

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

• Competence in preparing presentation slides for medical data review and safety review meetings.

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

• Understanding of data privacy regulations, International Committee on Harmonization (ICH) standards, and Good Clinical Practices (GCPs).

• Capability to adhere to enterprise, customer, project, standard operating procedures, and work instruction requirements.

• Equivalent experience, skills, and/or educational background 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.

• Provision of a company car or car allowance.

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

• Company-matched 401k plan.

• Eligibility to participate in the Employee Stock Purchase Plan.

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

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