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The World Leader In Serving Science
Sr Safety Committee Specialist - DSMB
Location
United States
Posted
67 days ago
Salary
0
Seniority
Senior
No structured requirement data.
Job Description
Sr Safety Committee Specialist - DSMB
Thermo Fisher Scientific
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.)
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