Medical/Clinical Scientist - ONC - Bladder Late Phase (Sponsor-dedicated/Remote)

About the role

Syneos Health is a leading fully-integrated life sciences services organization built to accelerate customer success. As a Medical/Clinical Scientist focused on Oncology (Bladder) late-phase studies, you will partner with the Medical Director to provide clinical and scientific input to early and late-stage clinical development programs, ensuring scientific integrity and data quality of clinical trials.

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.
• Authors medical data queries and reviews query responses, approves query closure in association with Medical Director.
• May assist Medical Director in patient profiles review, scientific review of other study level data, protocol deviation review, creation of Medical Review Summary report as needed.
• Partners with Medical Directors for medical data review meetings and safety review meetings including slide preparation as needed.
• Manages project scope of work, objectives, and quality of deliverables to ensure the project specific milestones and timelines are met.
• Serves as primary interface between internal team, customers, and vendors in the areas of medical data review and eligibility review.
• 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.
• May participate in internal and external audits.
• Acquires basic understanding and knowledge of ongoing protocol designs and disease related terminology and pathology.
• 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.
• May participate or conduct interviews.

Benefits

• 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
• Flexible paid time off (PTO) and sick time
• Eligibility for paid sick time may vary depending on where you work due to state and municipal regulations
• Syneos complies with all applicable federal, state, and municipal paid sick time requirements

Pay