Thermo Fisher Scientific
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.
Safety Administrator
Job not on LinkedIn
November 18
Thermo Fisher Scientific
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.
đź“‹ Description
• Provides contracted project coordination and safety support on global and domestic programs with an emphasis on targeted eligibility, protocol inquiries, and physician assessment of diagnostics. • In collaboration with Medical Project Coordinator (MPC) and Medical Monitors (MM), liaises and establishes effective relationships with internal functional team members to implement projects, prepare contractual documents, coordinate and facilitate meetings and accurately manage all incoming safety/ medical monitoring documentation. • Coordinates the timely review of protocol inquiries, triage of abnormal lab alerts and diagnostics; tracks all necessary data and generates reports for the client, project team and/or external vendors. • Coordinates/facilitates project meetings, drafts meeting minutes, posts blinded and unblinded minutes/materials to client portals and distributes to internal and external project teams. • Liaises with various internal function groups to implement projects, ensuring contractual obligations are met and timelines are achieved. • Manages project specific training in collaboration with the Project lead/manager, PSC, PV Lead, and the Project specific training team, including the application of training within the learning management system. • Manages the set-up, maintenance and archival of program files within CRG’s electronic filing system; ensuring PV remains audit ready by both identifying and resolving issues. • Identifies and redacts subject identifiers per local requirements, recommends site retraining to clinical team and escalates reoccurrences to the organization's Data Privacy. • Performs data entry into internal/external databases, tracking systems and performs system reconciliations to identify issues which may negatively impact project timelines. • Performs filing within various eTMF systems, both internally and externally, completing file review, uploading of documents, verifying expected documents, and utilizing different eTMF plans/TOCs/guides. • Maintains regional Medical Monitor Calendar. • Supports Medical Monitor Management with MM resourcing. • Performs manual tracking of PADFs, PIFs, and eligibility as needed/contracted. • Maintains SAE Review tracker for Medical Monitor only studies; including pertinent case-related information. • Supports any specific activities performed by the local office, which cannot be performed from elsewhere. • May provide training to junior staff.
🎯 Requirements
• Bachelor's degree • Previous experience that provides the knowledge, skills, and abilities to perform the job would be an advantage. • Firm knowledge of medical terminology • Ability to effectively delegate tasks and ensure successful completion • Ability to gain clear agreement and commitment from others through persuasion and influence • Effective presentation skills • Ability to provide constructive feedback and suggest improvements to the administrative process • Ability to assist in the management of a large project and to provide work direction and training to other safety support staff working on the project • Strong critical thinking skills and ability to use problem-solving techniques applicable to constantly changing environments • Ability to work independently with minimal supervision, demonstrating initiative • Ability to build strong relationships • Self-motivated, positive attitude with effective oral and written communication and interpersonal skills.
🏖️ Benefits
• Health insurance • 401(k) • Paid time off • Professional development opportunities
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