Principal Safety Committee Specialist - DSMB

at  Thermo Fisher Scientific

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

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:

• 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