Sr Endpoint Adjudication Specialist Hybrid SERBIA

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. 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

• Provide operational support to MCAM Manager and project team members across scoped services.

• Attend committee meetings and prepare committee meeting materials: agendas, meeting minutes and action items.

• File all MCAM project documents across all MCAM services to the Trial Master File (TMF)

• MCAM service specific responsibilities:

  • Distribute Safety Listings and Expedited Safety Reports for review to Committee Members

  • 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.

• May provide operational support to the MCAM Manager in the creation and maintenance of metric reporting for delivery to customer and/or internal team.

• Provide other work-related duties as assigned and/or outlined in the Committee Charter.

QUALIFICATION REQUIREMENTS;

• MS or PhD in life sciences, Medical, Pharmacy, or Nursing degree or equivalent combination of education and experience is required. 
• Strong understanding of the use of medical and scientific terminology in multiple environments required.
• Prior experience in study coordination, a contract research organization (CRO), pharmaceutical, or biotechnology company preferred.
• Strong organizational and time management skills.
• Ability to work independently.
• Excellent communication and interpersonal skills, both written and spoken.
• Knowledge of Good Clinical Practice (GCP)/ International Conference on Harmonization (ICH) guidelines and other applicable regulatory requirements.
• High proficiency with full MS Office Applications
• Ability to travel if necessary preferred (approximately 5%).
• High level of competence in English language.
• Experience in managing medical committees is required - DMC/DSMB, Safety Review Committee, Adjudication Committee etc.
• At least 4 year' experience in clinical trials environment.

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.