Sr Safety Committee Specialist - DSMB

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.)