Safety Committee Specialist – Adjudication

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🕒 June 15

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1956

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

Biotechnology • Pharmaceuticals • Science

Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

📋 Description

• Initiate CEC study start-up activities (charter development, member contracting, electronic adjudication system build) • Complete CEC/DSMB close-out activities • Perform day-to-day CEC activities through expert knowledge of specialty committee processes and procedures • Review adjudication publications and information sources to keep updated on current regulations, practices, procedures and proposals related to changes in CEC practices • Maintain medical understanding of applicable therapeutic area and disease states • Prepare and QCs CEC dossier compilation and submission • Assist 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 specialty committee functions

🎯 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 2+ years) • General understanding of pathophysiology and the disease process • Detailed knowledge of relevant therapeutic areas as required for CEC and/or DSMB review • Strong critical thinking and problem-solving skills • Good 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 • Previous exposure to Microsoft Office packages (including Outlook, Word, and Excel) • Understanding the importance of and compliance with procedural documents and regulations • 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 operate in a lead capacity

🏖️ Benefits

• Health and wellness support • Professional development opportunities • Commitment to health and wellbeing for employees