Safety Committee Admin- Adjudication

Work Schedule

Environmental Conditions

Job Description

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

Discover Impactful Work:

As a Safety Committee Admin, you are responsible to provide moderate contracted project coordination and safety support on global and domestic programs with an emphasis on Data and Safety Monitoring Boards (DSMB) and Endpoint Adjudication Committees (CEC). Performs DSMB/CEC set-up, member contract execution and tracking. Administers member payment set up, member honorary management and oversight, polls committee members and client Contacts for meeting dates and times. Arranges meeting facilities as needed for all contracted meetings and attends and completes meeting minutes for DSMB/CEC meetings as contracted. Provides oversight for all DSMB/CEC filing, assists the Safety Committee Specialist with dossier building and distribution and has a solid understanding of the Event Adjudication System. Acquires and supervises adjudication specific Documents for inclusion into dossier. In collaboration with Safety Committee Specialists, liaises and establishes effective relationships with internal functional team members to implement projects, prepare contractual documents, coordinate, and facilitate meetings and accurately run all contracted services for DSMB/CEC.

A day in the Life:

• Represents the DSMB/EAC Coordination Team at global and domestic committee meetings (both via teleconference and face-to-face) alongside the client, board members, third party vendors and the company's project team, coordinating all Logistical aspects and assisting with facilitation.
• Collaborate with various internal and external parties to implement contracted DSMB / Adjudication services for projects, prepare Confidentiality Disclosure Agreements, Letters of Intent and Member Agreements based on contractual considerations, reviewing all contractual documents for accuracy, and coordinating internal and external approvals.
• Compiles/creates/submits follow-up to investigative sites. Coordinates/facilitates project meetings, drafts meeting minutes, posts blinded and unblinded minutes/materials to client portals and distributes to internal and external project teams.
• Handles project specific training and the set-up, maintenance and archival of Program files; ensuring PV remains audit ready.
• Identifies and redacts subject identifiers per local requirements, retrains sites and escalates reoccurrences to the company's Data Privacy.
• Performs data entry into internal/external databases, tracking systems; performs system reconciliations to identify issues which may negatively impact project timelines.
• Supervises expenses including committee, travel or translation expenses ensuring proper escalation as needed for timely member payment.
• Supports any specific activities performed by the specialty committee team, which can be assisted by administrative support.

Keys to Success:

Education

Bachelor's degree

Previous experience that provides the knowledge, skills, and abilities to perform the job would be an advantage.

Knowledge, Skills, Abilities

• 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
• Good excel 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.

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today! http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.