Work ScheduleStandard (Mon-Fri)Environmental ConditionsOfficeJob DescriptionSummarized 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
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
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
