Role Description
The Sr Medical Scientist - HIV will work with the Medical Director to develop medical plans and engage with outside experts to coordinate necessary medical/scientific input. Responsibilities include:
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Developing medical plans (Medical Management Plan, Medical Data Review Plan, and Eligibility Review Plan).
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Performing regular and ad-hoc medical review of data listings and data visualization as needed.
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Analyzing data to identify risks and data patterns/trends; supporting documentation of medical reviews.
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Pro-actively identifying and resolving medical data review issues as they arise.
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Authoring medical data queries and reviewing query responses; approving query closure in association with Medical Director.
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Assisting Medical Director in patient profiles review and scientific review of other study level data.
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Partnering with Medical Directors for medical data review meetings and safety review meetings.
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Managing project scope of work, objectives, and quality of deliverables to ensure project milestones and timelines are met.
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Serving as primary interface between internal team, customers, and vendors in medical data review and eligibility review.
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Collaborating with study team members to identify risks related to data integrity and subject safety.
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Escalating ongoing and newly developed study concerns to project leads in a timely manner.
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Attending and presenting at Trusted Process meetings and participating in internal and external audits.
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Acquiring basic understanding of ongoing protocol designs and disease-related terminology and pathology.
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Adhering to all data privacy guidelines, ICH, GCPs, and enterprise policies.
Qualifications
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Degree in life sciences (Bachelors) or related discipline in natural sciences/health care field.
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2-3 years of clinical research experience.
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Excellent time management skills to handle multiple tasks and meet deadlines.
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Self-starter comfortable with fluctuating timelines and work demands.
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Ability to troubleshoot situations and escalate issues to leadership when necessary.
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Understanding of scientific principles for effective medical data analysis.
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Excellent written and oral communication skills.
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Excellent computer skills: MS Office programs, spreadsheets, presentations.
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Knowledge of drug development and proficiency with ICH/GCP guidelines.
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Strong team player with excellent interpersonal skills.
Requirements
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Degree in life sciences or related discipline.
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2-3 years of clinical research experience.
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Excellent time management and organizational skills.
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Ability to work in a highly regulated and dynamic environment.
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Strong communication and interpersonal skills.
Benefits
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Company car or car allowance.
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Health benefits including Medical, Dental, and Vision.
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Company match 401k.
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Eligibility to participate in Employee Stock Purchase Plan.
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Eligibility to earn commissions/bonus based on performance.
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Flexible paid time off (PTO) and sick time.
Salary Range
$79,800.00 - $139,600.00. Actual salary will vary based on qualifications, skills, competencies, and proficiency for the role.