Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
Summarized Purpose:
Performs experienced day-to-day committee activities for Clinical Endpoint Committees (CEC) and/or Data Safety Monitoring Boards (DSMB) within a highly regulated environment. Displays an experienced knowledge of the procedures and electronic platforms/ software systems utilized for direct
communications with the CEC and/or DSMB committees 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:
- Proficient in CEC/DSMB study start-up activities (charter development, member contracting, electronic adjudication system build) and close-out activities.
- May act as the company's liaison for CEC/DSMB with the sponsor and assist the company's project teams in executing CEC/DSMB strategies
- Works independently to perform 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.
- 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. - May assist in the preparation 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).
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:
- Thorough understanding of pathophysiology and the disease process
- Strong knowledge of relevant therapeutic areas as required for CEC and/or DSMB review
- Excellent critical thinking and problem-solving skills
- Excellent oral and written communication skills including paraphrasing skills
- Good command of English and ability to translate information into local language where required
- Computer literate with the ability to work within multiple databases
- Proficient in Microsoft Office packages (including Outlook, Word, and Excel)
- Thorough understanding of the importance of and compliance with procedural
- Ability to manage and prioritize a variety of tasks and meet strict deadlines with limited supervision
- 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 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:
- Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
- Able to work upright and stationary for typical working hours.
- Ability to use and learn standard office equipment and technology with proficiency.
- Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
- May require travel. (Recruiter will provide more details.)