Syneos Health

Endpoint Adjudication Specialist Poland

1 day left

Location
Poland
Salary
Competitive
Posted
03 Feb 2021
Closes
05 Mar 2021
Ref
KK/21001656
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Here at Syneos Health we are currently recruiting for an Endpoint Adjudication Specialist.

 

JOB SUMMARY

Provides administrative support to the sponsor and Syneos Health project teams and medical committee members serving on Data Monitoring Committee(s) to assess subject safety within clinical trials. Interacts with investigative sites, sponsor and Syneos Health project teams and medical committee members to ensure communication and evidence of adverse events reported by the investigational sites are presented to the Event/Endpoint Adjudication Committee (EAC).

 

JOB RESPONSIBILITIES

• Provide administrative support to the Medical Committee Manager.
• Obtain documentation related to selection and contracting of medical committee members, logistics and maintenance of all committee-related documentation.
• Manage transmissions to the collaborative workspace and Trial Master File as applicable per study and SOP requirements.
• Attend, participate in, and prepare draft meeting minutes and action items for DMC and EAC meetings.
• Perform additional tasks as outlined in applicable medical committee project plans.
• Manage data and documentation supporting EAC presentation of eligible adjudication events, inclusive of Protected Health Information (PHI) evaluation and redaction, evidence of event reported for adjudication.
• Initiate queries 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 team metrics and Quality Assurance/Control measures (team or department initiatives).
• Provide knowledge regarding international guidance / regulations related to medical committees to operational teams and/or investigational sites.
• Responsible for performing activities that are in compliance with applicable Corporate and Divisional Policies, Standard Operating Procedures and Operating Guidelines and performing other duties as assigned by management

 

 

QUALIFICATION REQUIREMENTS

• Bachelor’s Degree in related Health Sciences - Registered Nursing Degree preferred.   In lieu of a degree work related experience equivalent (2 years) in EAC / DMC with demonstrated experience

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

• The Medical Committee Specialist will need effective organizational, interpersonal skills, communication skills, and group presentation skills; above average attention to detail, accuracy, 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.

 

Disclaimer:
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.