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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:

Project coordination and safety support on global and domestic programs with an emphasis on serious and non-serious adverse events, protocol inquiries, physician assessment of diagnostics, Data and Safety Monitoring Boards and Endpoint Adjudication Committees.

A day in the Life:

• Coordinates the timely review of protocol inquiries, serious and non-serious

adverse events, diagnostics, DSMB/EAC data and aggregate report data; 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.

• Assists in the generation of QPPV compliance metrics.

• Identifies and redacts subject identifiers per local requirements.

• Performs data entry into external databases, tracking systems and the

organization's budget management system; performs system reconciliations to

identify issues which could negatively impact project timelines.

• Compiles adjudication dossiers and creates/submits follow-up to investigative sites.

• Oversees expensing/invoicing and manages translations; ensuring budget

parameters are not exceeded.

• Mentors junior staff.

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

• 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.

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.