首席医学科学家（项目负责人） - RWE - 波兰、保加利亚、罗马尼亚、斯洛伐克

Principal Medical Scientist (Project Lead) - RWE - Poland, Bulgaria, Romania, Spain, UK - Sponsor-dedicatedSyneos 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. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.
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.
Discover what our 29,000 employees, across 110 countries already know:
WORK HERE MATTERS EVERYWHERE
Why Syneos Health

• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.

• We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.

• We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.

Job 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 (set-up and/or lead meetings as appropriate) 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, 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.

QUALIFICATION:
Training and Education
· BA/BS Degree in life sciences or health related field with 5+ years practical experience or MS/MBA with 3+ years, PharmD/PhD 2 years, MD/DO with 1 year
Prior Experience and Capabilities

• Industry experience in the Clinical Scientist role or similar capacity.

• Experience working on multinational teams/studies

• Hands-on experience in epidemiology study design, conduct and analysis.

• Experience in or leading study teams

• Experience working independently and collaborating with multiple functional groups within and outside the business line

• Demonstrated an ability working across multiple studies for incorporation of consistent medical/scientific concepts in multiple protocols

• Strong knowledge of the clinical research process and Good Clinical Practices (GCPs), monitoring, clinical and regulatory operations

• Demonstrated independent authorship of study protocols and other study documents

• Working knowledge of statistics, data analysis, and data interpretation

• Experienced in managing external vendors for clinical and/or epidemiological study(ies)

Get to know Syneos Health
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
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. Learn more about Syneos Health.

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. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
Originally posted on Himalayas