Senior Clinical Scientist Clinical Surveillance & Training

Senior Clinical Scientist Clinical Surveillance & Training

Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.

Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.

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 deliver – for one another, our customers, and, most importantly, for those in need.

Discover what your 25,000 future colleagues already know:

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 building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.

Job Responsibilities

• Contributes to draft protocol review, scale selection, and may contribute to full protocol design and development, offering clinical expertise and partnering with customers on design and specific text Participates in the development of eligibility review, endpoint review, rater qualification, training, and certification plans, documents, reports, etc.
• Contributes to scales management and translations deliverables Reviews case report forms and electronic clinical outcome assessment (eCOA) pages to ensure consistency between the database and original scale, and provides feedback to team Works with vendors and/or Company staff involved in training regarding the use of clinical scales, diagnostic instruments, or provision of (eCOA) technology
• Provides internal Syneos Health and site staff training on therapeutic indications, scale administration, and scale scoring
• Performs clinical and statistical analysis of rating scale, and/or endpoint data Works with Investigators and their staff in order to ensure that they understand the specifics of the protocol, particularly surrounding entry criteria, diagnostic scales, and clinical scales In collaboration with Medical Directors, reviews screening data and leads case reviews to determine whether subjects are appropriate for entry into a trial
• Provides professional, collaborative, and scientific feedback to investigators
• May perform final review and quality control check of documents and materials drafted by other CST members Continuously improves clinical and scientific expertise through research and publication.
• Maintains familiarity with current relevant literature
• Provides scientific and clinical expertise to Sponsors, study teams, and the Company.
• May serve as indication and CST service subject matter expert Supports business development activities by providing scientific proposal text, protocol considerations and/or slides.
• May participate in bid defense meetings
• May contribute to strategic CST process improvement, team growth, and infrastructure development
• Provides CST-specific training and support to other CST members in accordance with protocol and/or project requirements, including therapeutic, protocol specific, and process training May line manage and/or mentor other CST members

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:

$134,400.00 - $255,400.00

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.

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.

Summary

Provides scientific oversight and clinical guidance for projects within the Clinical Surveillance & Training (CST) department. Works with assigned team to develop and deliver eligibility review, end point review, rater training, scales management and translation, and other services as needed. Applies advanced clinical and trial methodology expertise to help ensure quality of subject selection and reliability/validity of outcome data in assigned clinical trials, advancing evidence-based science with every touchpoint/service. Plays an integral role in the implementation of CST programs, ensuring timely delivery of services and advancing evidence-based scientific activities within the team. Provides both internal and external therapeutic training and assessment instrument training as needed and as indication expertise applies. Interacts with senior management, customers, and project teams to ensure scientific integrity and data quality in clinical trials. Provides scientific input as needed within the company and contributes to business development activities. May serve as line manager and/or mentor to one or more CST members.