Overview
Principal Medical Scientist (Project Lead) - RWE - Poland, Bulgaria, Romania, Spain, UK
Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.
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Responsibilities
- 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 monitoring, medical data review, eligibility review and other project specific medical services.
- Works with Medical Directors to develop medical plans (Medical Management Plan, Medical Data Review Plan, and Eligibility Review Plan). Works with customers to develop non-standard procedures and project plans.
- Performs regular and ad-hoc medical review of data listings and visualizations 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. Provides advanced medical data review on various project level data as needed.
- Collaborates with study team members including Clinical Operations, Data Management, Drug Safety and Pharmacovigilance, and Project Management to identify risks related to data integrity and subject safety. Identifies and 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. Troubleshoot situations as needed.
- Acts as key scientific leader on customer partnership/portfolio/coalition level. Attends strategic meetings with customers. Leads Scientific Services team on a project and evaluates resourcing needs.
- Serves as respective area’s Subject Matter Expert (SME) to ensure that project teams consistently operate in compliance with research principles and procedures. Provides scientific oversight and project/product development training to Company staff and project teams.
- Attends and presents at Trusted Process meetings and may participate in internal and external audits or inspections. Assists with responding to findings from audits or inspections.
- Contributes to general and project-specific training. Assists Medical Director(s) on the review and development of training material and project-level documents, including but not limited to clinical protocols, clinical study reports, abstract and manuscripts, presentations, investigator brochures, and various other internal and external documents and communications as needed.
- Develops, or oversees the development of, work orders and change orders for projects involving MSM.
- Contributes to Company business development activities by providing scientific input into data collection tools, data monitoring plans, requests for proposals (RFPs), as assigned.
- Acquires understanding and knowledge of ongoing protocol designs and disease related terminology and pathology.
- Provides strategic oversight and active contributions to the planning and development of medical monitoring and scientific services activities, as well as provides direction and oversight across all research projects, and other research-related activities.
- Evaluates processes for improvement in efficiency and effectiveness and recommends changes; participates in process development and improvement of departmental functions.
- Adheres to all data privacy guidelines, ICH, and 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.
Additional Information
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. This description complies with applicable laws and is intended to reflect requirements for the role.
Summary
Demonstrates process expertise and therapeutic area knowledge. Acts as a key scientific leader on projects. Collaborates with Medical and Scientific Management (MSM) team members as well as with functions outside to provide high-quality deliverables. Responsible for coordinating the functional team members and their activities for medical and scientific services, liaising with project leadership and the customer to ensure that the MSM deliverables (timelines, quality, productivity) are met. This role has overall accountability for the execution of the Medical Management strategy on the project.
Seniority level
Employment type
Job function
- Research, Analyst, and Information Technology
No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment.
