Lead Clinical/ Medical Scientist - LEAD-Oncology - Gynecologic Malignancies
About The Position
Syneos Health is a leading life sciences services organization that partners with innovators across the drug development and commercialization continuum. The Clinical Solutions team members act with a drug development mindset, applying their expertise to understand customer needs and shape solutions. Whether in a Functional Service Provider partnership or a Full-Service environment, you will collaborate with passionate problem solvers to help customers achieve their goals. Syneos Health is agile and driven to deliver for its colleagues, customers, and patients. The company focuses on developing its people through career development, supportive management, training, and a total rewards program. They are committed to building an inclusive culture where individuals can be authentic, driven by a purpose to shape solutions that dramatically impact lives. Syneos Health aims to shape the future of healthcare by bringing together smart colleagues globally, driving impact for customers and defining the pace of patient progress.
Requirements
- Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description.
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.
- Attends and present at Trusted Process meetings and 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 manage limited number of direct reports. 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
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
No Education Listed
