Work Schedule

First Shift (Days)

Environmental Conditions

Office

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.

Summarized Purpose:

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.

Essential Functions and Other Job Information:

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/guidesMaintains regional Medical Monitor CalendarSupports Medical Monitor Management with MM resourcingPerforms manual tracking of PADFs, PIFs, and eligibility as needed/contractedMaintains SAE Review tracker for Medical Monitor only studies; including pertinent case-related informationSupports any specific activities performed by the local office, which cannot be performed from elsewhere.May provide training to 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, AbilitiesFirm knowledge of medical terminologyAbility to effectively delegate tasks and ensure successful completionAbility to gain clear agreement and commitment from others through persuasion and influenceEffective presentation skillsAbility to provide constructive feedback and suggest improvements to the administrative processAbility to assist in the management of a large project and to provide work direction and training to other safety support staff working on the projectStrong critical thinking skills and ability to use problem-solving techniques applicable to constantly changing environmentsAbility to work independently with minimal supervision, demonstrating initiativeAbility to build strong relationshipsSelf-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.