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

• Perform responsibilities for the establishment of a clinical trial committee which may include:
  • Identify potential members to serve on trial committees.
  • Collect potential and selected committee member documents i.e. NDAs, CVs, etc., and perform initial assessments i.e. debarment checks, conflict of interest attestation, etc.
  • Manage the negotiation and execution of contractual agreements.
  • Receive, submit and track committee member invoices against the project budget and member contracted services.
• Perform responsibilities as per Committee Charter and applicable project plan(s) which may include:
  • Schedule and attend committee meetings.
  • Prepare and/or distribute committee meeting materials: agendas, meeting minutes, etc. and document and track meeting action items.
  • Distribute safety listings, expedited safety reports, protocol and other relevant trial documents to committee members for review.
  • Review clinical event/endpoint documentation to ensure completeness of adjudication package, appropriate redaction of Protected Health Information (PHI) and to identify any potential unreported clinical endpoints or events requiring adjudication.
  • Initiate queries to site(s) as applicable for potential discrepant or missing data and follow to resolution.
  • Manage translation services to be provided via scope of work including submission, tracking and assurance of page equivalent upon return of translation.
  • Support User Acceptance Testing (UAT) of Committee’s collaborative workspace and/or electronic adjudication platform.
  • Provide operational support to the Committee Manager in the creation and maintenance of metric reporting for delivery to customer and/or internal team.
• File all project-specific trial committee documents in the Trial Master File (TMF).

Qualifications

• Bachelor's degree in Life Sciences, Medicine, Pharmacy, Nursing, or a related field, or an equivalent combination of education and experience, required.
• Previous experience in study coordination or within a Contract Research Organization (CRO), pharmaceutical, or biotechnology company preferred.
• Strong understanding of medical and scientific terminology across various clinical and scientific environments preferred.
• Strong organizational and time management skills.
• Excellent attention to detail, with the ability to adapt to changing project requirements while maintaining high-quality deliverables.
• Excellent written and verbal communication and interpersonal skills.
• Knowledge of Good Clinical Practice (GCP), International Conference on Harmonization (ICH) guidelines, and other applicable regulatory requirements.
• Proficiency in Microsoft Office applications.
• Willingness and ability to travel as needed (approximately 5%) preferred.
• High level of proficiency in English, both written and spoken.

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.

http://www.syneoshealth.com

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.