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Syneos Health logo
Syneos Health

Over the past 5 years, we have worked with: 94% of all Novel FDA Approved Drugs 95% of EMA Authorized Products 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 at 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.

Clinical Operations Specialist – Managed Access Program Admin

Clinical OperationsClinical OperationsFull TimeRemoteSeniorTeam 10,001+H1B SponsorCompany SiteLinkedIn

Location

Australia

Posted

83 days ago

Salary

0

Seniority

Senior

High SchoolEnglish

Job Description

Clinical Operations Specialist – Managed Access Program Admin

Syneos Health

• Responsible for performing activities in compliance with applicable Corporate and Clinical Operations Policies, Standard Operating Procedures and Work Instructions • Assists Clinical Monitoring staff with site management activities, including serving as a Sponsor representative for sites on assigned studies, and communicating with sites to ensure compliance with protocol requirements, study procedures and relevant guidelines • Creates and assists with maintenance of Trial Master File (TMF) and project files, including participation in file audits • Prepares and maintains site manuals, reference tools and other documents • Maintains, updates, and inputs clinical tracking information into databases • Tracks incoming and outgoing clinical and regulatory documents and updates for investigator sites, studies, project team, or client • Manages shared mailbox, processes site requests and routes correspondence appropriately • Coordinates the ordering, packaging, shipping and tracking of site supplies and materials • Assists with coordination of team meetings, attends meetings and prepares accurate meeting minutes and action items • May handle receipt, tracking and disposition of Case Report Forms and Queries • Maintains overall awareness in the field of clinical research by completing all necessary and assigned training

Job Requirements

  • High School diploma or equivalent
  • Good communication and interpersonal skills
  • Ability to embrace new technologies
  • Minimal travel up to 25% may be required

Benefits

  • 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

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Cardiovascular disease remains the leading cause of death in America. At Chamber, we’re rebuilding the system for cardiology, creating a world where outcomes, not volume, define success. We partner with independent cardiologists to help them lead population health efforts in their communities, equipping them with technology, data, and operational tools that turn complex insights into better care for patients. Our model blends clinical expertise, thoughtful design, and a modern operating platform that supports physicians, patients, and payers alike. We believe innovation and empathy go hand in hand, and by combining cutting-edge AI tools with a relentless focus on human care, we can transform heart health at scale. Location Candidates must be based in the Eastern or Central time zone and will work remotely. Periodic travel to practice sites or Chamber offices may be required.

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