Senior Safety Committee Specialist - Adjudication at Thermo Fisher Scientific in Raleigh, North Carolina

Posted in Other about 9 hours ago.





Job Description:

Work Schedule

Standard (Mon-Fri)



Environmental Conditions

Office



Job Description




ummarized 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 committee's 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:



  • 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 initiatives; 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 specialty 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 5+ years).

  • Excellent oral and written communication and technical skills including paraphrasing skills

  • Writes and prepares meeting minutes for Data Safety Monitoring Board (DSMB) meetings, and other Safety Meetings.

  • Assists with project-level tasks, which included developing reports, providing logistical support for client meetings, corresponding with clients, and attending safety meetings


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


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