Endpoint Adjudication Spec II

Description

Endpoint Adjudication Spec II

Come discover what our 25,000+ employees already know: work here matters everywhere. We’re a growing and evolving biopharmaceutical industry leader, which means you’ll have endless opportunities to work with experts around the world and build the career you’ve dreamed of.
As a part of the Syneos Health team, you’ll help us deliver results for a rewarding reason – we improve patients’ lives around the world. Because to us, a patient isn’t just a number, they’re our family, friends, and neighbors.

Why Syneos Health

• #SyneosHealthLife means we’re committed to our Total Self culture – where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person’s unique contributions make a difference.
• We believe our success is a direct result of the people who are driving it – you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That’s why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial.
• 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 SUMMARY

The position is responsible for the identification of potential clinical events, as well as the collection, review and preparation of required documentation for review by clinical event or adjudication committees.

MAJOR RESPONSIBILITIES

• Obtain, review, and process Investigator Record of Potential Endpoint / Event forms from Investigator sites in hard copy or within electronic environment.
• Follow-up with Investigator sites to obtain additional supporting documentation and materials for potential endpoints or events.
• Review medical information via hard copy or within an electronic environment to ensure completeness of endpoint or event package, to redact patient-specific protected information, and to identify any unreported potential endpoints or events.
• Review Adverse Event (AE) / Serious Adverse Event (SAE) and other data listings and provide appropriate follow-up with the Investigator site to ensure that all potential endpoints or events have been reported.
• Prepare and distribute endpoint or event documentation packets and materials for Clinical Events Committee review.
• Assist with preparation for periodic Clinical Events Committee meetings.
• Resolve event-related queries of Clinical data, as needed.
• Maintain project tracking systems of subject and site information. * Participate in company and/or client required training programs.
• Train and mentor junior Endpoint Adjudication staff on study-specific and internal procedures.
• May interact with Clinical Events Committee.
• May have direct interactions with representatives of Sponsor affiliates both within and outside clinical (e.g. Medical, Marketing, Commercial

Qualifications

EXPERIENCE REQUIRED

• Bachelor’s Degree in related Health Sciences - Registered Nursing Degree preferred. In lieu of a degree work related experience equivalent (6 years) in IAC / IDMC with demonstrated experience.

• A strong understanding of the use of medical terminology in multiple environments is expected. A strong proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), email (Outloook), voicemail and smartphone.

• The Sr Endpoint Adjudication Specialist will need effective organizational, interpersonal skills, communication skills, and group presentation skills; above average attention to detail, accuracy, organizational, interpersonal, and team-oriented skills.

• Ability to handle multiple tasks to meet deadlines in a dynamic environment is essential. Ability to be customer-focused and have a disciplined approach to work is critical. Fluency in written and spoken English is essential

• Requirements may include travel as required by the sponsor or study team (estimated at 25% post Covid)

Get to know Syneos Health
We are the only full-service biopharmaceutical solutions company in the world. That means we bring together the best clinical and commercial minds to create a better, smarter, faster way to get medicines into the hands of patients who need it most. 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.

As a healthcare company we have an important responsibility to protect individual and public health. Except in those locations where state or local law impacts this vaccination requirement, this position will require individuals to be fully vaccinated against COVID-19 as part of their job responsibilities unless an exemption can be confirmed based on a medical condition, sincerely-held religious belief, or other reasons recognized by applicable law. Submission and approval of an exemption request does not necessarily guarantee that an accommodation can be provided for any specific job.