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Principal Safety Committee Specialist - Adjudication

AT Thermo Fisher Scientific
Thermo Fisher Scientific

Principal Safety Committee Specialist - Adjudication

Remote

Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

Summarized Purpose:

Ensures day-to-day committee activities for Clinical Endpoint Committees (CEC) and/or Data Safety Monitoring Boards (DSMB) completed within a highly regulated environment. Displays an advanced knowledge of the procedures and electronic platforms/ software systems utilized for direct communications with the CEC and/or DSMB commitees and other external and pre-existing software systems. Effectively collaborates with various parties such as: project team members, data management, biostatistics, client contacts, investigators, committee members, and third party vendors.

Essential Functions:

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  • Works independently providing expertise in overseeing oversee day to day CEC/DSMB activities.
  • Exercises independent judgement to troubleshoot and resolve project issues and identify areas for improvement.
  • Functions in a lead role. Serves as primary point of contact in the absence of the manager. Mentors less experienced staff.
  • Acts as primary study contact or lead with internal and/or external clients.
  • Initiates CEC/DSMB study start-up activities (charter development, member contracting, electronic adjudication system build) and close-out activities.
  • Performs day-to-day CEC / DSMB activities through expert knowledge of specialty committee processes and procedures.
  • Reviews adjudication/DSMB publications and information sources to keep updated on current regulations, practices, procedures and proposals related to changes in CEC and DSMB practices.
  • Maintains medical understanding of applicable therapeutic area and disease states.
  • Prepares and QCs CEC dossier compilation and submission.
  • Maintains secure files for DSMB unblinded data.
  • Assists with routine project implementation and coordination, including presentations at client/investigator meetings, and review of metrics and budget considerations as they relate to specialty committee activities.
  • Participates in/leads departmental initiative; serves as a subject matter expert in designated area, including business development.
  • May assist in the preparation and development of departmental and project specific procedures and processes, prepare for and attend audits, kick-off and investigator meetings representing the CEC and/or DSMB speciality committee functions

Qualifications:

Education and Experience:

  • Bachelor's degree or equivalent and relevant formal academic / vocational qualification
  • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ 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 and Abilities:

  • Excellent understanding of pathophysiology and the disease process
  • Expertise of relevant therapeutic areas as required for CEC and/or DSMB review
  • Advanced critical thinking and problem solving skills with ability to evaluate and escalate appropriately
  • Solid project management skills with the ability to manage multiple projects simultaneously
  • Ability to motivate, mentor and provide guidance to less experience staff
  • Proficient at complex clinical study administration including budget activities and forecasting
  • Excellent oral and written communication skills including paraphrasing skills
  • Good command of English and ability to translate information into local language where required
  • Advanced computer skills with the ability to work within multiple databases
  • Advanced skills in Microsoft Office products (including Outlook, Word, and Excel)
  • Thorough understanding of the global regulatory requirements and the importance of and compliance with procedural documents and regulations
  • Strong attention to detail
  • Ability to maintain a positive and professional demeanor in challenging circumstances
  • Ability to work effectively within a team to attain a shared goal

Job ID: ThermoFisher-R-01290904
Employment Type: Full Time

Perks and Benefits

  • Health and Wellness

    • Health Insurance
    • Dental Insurance
    • Vision Insurance
    • Life Insurance
    • Short-Term Disability
    • Long-Term Disability
    • FSA
    • HSA
    • HSA With Employer Contribution
    • Mental Health Benefits
    • Fitness Subsidies
  • Parental Benefits

    • Adoption Leave
    • Birth Parent or Maternity Leave
    • Non-Birth Parent or Paternity Leave
    • Fertility Benefits
    • Adoption Assistance Program
    • Family Support Resources
  • Work Flexibility

    • Flexible Work Hours
    • Hybrid Work Opportunities
    • Remote Work Opportunities
  • Office Life and Perks

    • Commuter Benefits Program
    • On-Site Cafeteria
  • Vacation and Time Off

    • Paid Vacation
    • Paid Holidays
    • Volunteer Time Off
  • Financial and Retirement

    • 401(K) With Company Matching
    • Stock Purchase Program
    • Financial Counseling
    • Performance Bonus
  • Professional Development

    • Tuition Reimbursement
    • Access to Online Courses
    • Internship Program
    • Mentor Program
  • Diversity and Inclusion

    • Employee Resource Groups (ERG)
    • Diversity, Equity, and Inclusion Program