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Medical Committee and Adjudication Management Specialist

Employer
Syneos Health
Location
Krakow-22-Zielinskiego, POL
Salary
Competitive
Start date
27 Aug 2021
Closing date
25 Sep 2021

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Discipline
Clinical Research, Pharmacovigilance
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

Here at Syneos Health we are currently recruiting for an Medical Committee and Adjudication Management Specialist

Job Details

Interacts with sponsors, project teams and consultants to ensure communication and evidence of adverse events reported by the investigational sites are presented to the Independent Adjudication Committee or Data Monitoring Committee(s) to assess subject safety within clinical trials.

Responsibilities for this role are as follows:
  • Provides knowledge regarding international guidance / regulations related to committees to operational teams and/or sponsor.
  • Primary or Secondary interface as an Operational Manager or specific MMSS Study Manager providing support for services Independent Data Monitoring Committees (IDMC) or Independent Adjudication Committees (IAC) including assisting in selection and contracting of members, logistics and attendance of study meetings and maintenance of all committee-related documentation
  • Evaluate site reported Adverse Events (AE) for clarification or potential unreported events to be reported to committee(s); this may include listings presented for IDMC data presentation.
  • Management of documentation supporting IAC presentation of eligible adjudication events, inclusive of PHI evaluation, evidence of event reported for adjudication.
  • Initiate queries as applicable for potential discrepant data and follow to resolution.
  • Attend applicable meetings ( Trusted Process Meetings, team meetings, Scientific Committees
  • Develop and/or review Patient Profiles / Event Summaries
  • Support team metrics and Quality Assurance/Control measures (team or department initiatives)
  • 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.
The ideal candidate will need the following experience / skills to be considered:
  • Bachelor's Degree in related Health Sciences - Registered Nursing Degree preferred. In lieu of a degree work related experience equivalent (4 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 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%)

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