Safety Committee Administrator

Job Title: Safety Committee Administrator

Job Location: Remote, North Carolina, USA

Job Location Type: Remote

Job Contract Type: Full-time

Join Us as a Safety Committee Administrator

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.

The Safety Committee Admin provides moderate contracted project coordination and safety support on global and domestic programs with an emphasis on Data and Safety Monitoring Boards (DSMB) and Endpoint Adjudication Committees (EAC). Performs DSMB/EAC set-up, member contract execution and tracking. Administers member payment set up, member honoraria management and oversight, polls committee members and client contacts for meeting dates and times. Arranges meeting facilities as needed for all contracted meetings and attends and completes meeting minutes for DSMB/CEC meetings as contracted. Provides oversight for all DSMB/CEC filing, assists the Safety Committee Specialist with dossier building and distribution and has a working knowledge of the Event Adjudication System. Obtains and tracks adjudication specific documents for inclusion into dossier. In collaboration with Safety Committee Specialists, liaises and establishes effective relationships with internal functional team members to implement projects, prepare contractual documents, coordinate and facilitate meetings and accurately manage all contracted services for DSMB/EAC.

• Represent the DSMB/EAC Coordination Team at global and domestic committee
  meetings (both via teleconference and face-to-face) alongside the client, board
  members, third party vendors and the company's project team, coordinating all
  logistical aspects and assisting with facilitation.
  • Interface with various internal and external parties to implement contracted
  DSMB / Adjudication services for projects, prepare Confidentiality Disclosure
  Agreements, Letters of Intent and Member Agreements based on contractual
  considerations; reviewing all contractual documents for accuracy and
  coordinating internal and external approvals.
  • Compile/create/submit follow-up to investigative sites.
  • Coordinate/facilitate project meetings, draft meeting minutes, post blinded
  and unblinded minutes/materials to client portals and distribute to internal and
  external project teams.
  • Manage project specific training and the set-up, maintenance and archival of
  program files; ensuring PV remains audit ready.
  • Identify and redact subject identifiers per local requirements, retrain sites
  and escalate reoccurrences to the company's Data Privacy.
  • Perform data entry into internal/external databases, tracking systems; perform
  system reconciliations to identify issues which may negatively impact project
  timelines.
  • Oversee expenses including committee, travel or translation expenses ensuring
  proper escalation as needed for timely member payment.
  • Support any specific activities performed by the specialty committee team,
  which can be assisted by administrative support.
  
  Education and Experience Requirements:
  • High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification
  • Technical positions may require a certificate
  • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 2 years).
  
  In some cases an equivalency, consisting of a combination of appropriate education, training
  and/or directly related experience, will be considered sufficient for an individual to meet the
  requirements of the role.
  
  Knowledge, Skills, Abilities:
  • Strong problem-solving skills
  • Ability to work independently with minimal supervision, demonstrating initiative
  • Know how to build strong relationships
  • Ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency
  • Ability to act as a liaison and communicate respectfully and diplomatically with all clients,
  management, project team members and other internal staff
  • Self-motivated, positive attitude with effective oral and written communication and interpersonal skills
  • Excellent computer skills to include: MS Office (Word, Excel, PowerPoint, Access)
  • Ability to identify and set priorities and effectively perform a variety of tasks simultaneously with strict
  deadlines
  • Strong attention to detail and accuracy with orientation toward careful and meticulous work
  • Ability to maintain a positive and professional demeanor in challenging circumstances
  • Flexibility to reprioritize workload to meet changing project timelines
  • Demonstrated ability to attain and maintain a good working knowledge of applicable FDA
  Regulations, ICH Good Clinical Practices, and the company's/Client SOPs and WPDs for all non clinical/clinical aspects of project implementation, execution and closeout
  
  Working Environment:
  Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:
  
  • Work is performed in an office or clinical environment with exposure to electrical office equipment.
  • Occasional drives to site locations. Potential Occasional travel required.
  
  Why join us?
  When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly make a difference.
  
  Apply today to help us deliver tomorrow’s breakthroughs.

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Originally posted on Himalayas