Sr Safety Committee Specialist - DSMB

Thermo Fisher Scientific • Morrisville, NC

4d • Onsite

About The Position

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.

Requirements

• 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).
• 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
• 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.

Responsibilities

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees