Sr Medical Scientist - Infectious Disease - HIV

Job Responsibilities
• Works with Medical Director to develop medical plans (Medical Management Plan, Medical Data Review Plan, and Eligibility Review Plan). Engages with outside experts/consultants/advisors to coordinate the acquisition of necessary medical/scientific input to prepare the respective medical plans.
• Performs regular and ad-hoc medical review of data listings and data visualization as needed; analyzes the data to identify risks and data patterns/trends and supports documentation of medical reviews. Pro-actively identifies and resolves medical data review issues as they arise. Review of SAE reports.
• Authors medical data queries and reviews query responses, approves query closure in association with Medical Director.

. Clinical point of contact for scientific issues/questions for internal and external stakeholders (e.g., IRB, sites)
• Responsible for trial design and endpoint development in collaboration with Medical Director
• Sets up/supports SAC, DMC, adjudication committees
• Protocols/amendments - collaborates with medical writer, participates in governance committee review
• Authors protocol clarification letters
• Contributor to study specific documents (e.g., SMP)
• Reviews/updates informed consent
• Provides scientific input to PM for data management activities (e.g., EDC, DRP, CRFs)
• Monitors data issues requiring clinical input
• Monitors central lab reports and other external data for safety and critical values
• Prepares scientific slides, attends and presents protocol information at Investigator Meeting
• Reviews specifications, initiates allocation request form and approval schedule in allocation schedule generation system
• Coordinates planning of lab, bio specimens and imaging specifications
• May co-author newsletters with PM
• Participates in Database lock activities
• Collaboratively plans CSRs and other deliverables with medical writing
• Supports publications/presentations as needed
• Reconciles and review all protocol deviation classifications and periodic reviews
• Assesses and prepares protocol deviation list for CSR
• Collaborates with medical writing to develop trial results communication for investigators
• Provides scientific assessment for Operational Reviews
• Supports PM, Stats, Medical Writing and other activities as needed to achieve study deliverables.
• Provides clinical specifications to study team to support interactions with external vendors
• May act as mentor to other CSs
• Collaborates with study team members including Clinical Operations, Data Management, Drug Safety and Pharmacovigilance, and Project Management (set-up and/or lead meetings as appropriate) to identify risks related to data integrity and subject safety. Escalates ongoing and newly developed study concerns such as at-risk project deliverables and out of-scope tasks to the project leads in a timely manner.
• Adheres to all data privacy guidelines, International Committee on Harmonization (ICH), and Good Clinical Practices (GCPs), all enterprise policies, standard operating procedures, work instructions, and project plans. Adheres to customer policies and standard operating procedures, as required in project plans.

At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements.

Salary Range:
$79,800.00 - $139,600.00

The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role.