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.
Responsibilities:
Provides support to clinical supplies operations and administrative activities in all areas of clinical supplies' lifecycle of low to moderate complexity studies.
Coordinates, supports and performs logistics and administrative work to support the department.
Supports the day to day operations of the study drug, comparators and ancillaries management.
Ensures all activities are implemented in compliance with company good practices and client requirements.
Completes ongoing training on new regulations concerning all clinical supplies and GxP activities.
Participates in and supports department project teams.
May coordinate or serve as a liaison cross-functionally.
Oversee the daily drug product/medical device receipt, ordering, storage, label printing, labeling activities, inventory management, distribution, return drug accountability and destruction
Ensure all activities implemented by PPD Depots align with company SOPs, and Client requirements.
Track inventories and expiration dates of all department drug products and medical devices. Issue monthly status reports.
Arranges purchases of additional supplies upon request.
Maintains accurate data in electronic management systems for assigned studies
Education
High school diploma or equivalent experience is required
Relevant formal academic or vocational qualification preferred
Experience
Minimum of 2 years of logistics coordination experience
Skills
Proven ability to successfully implement logistics strategies and improve operational efficiency
Strong proficiency in Microsoft Office Suite and ability to learn new software quickly
Excellent verbal communication skills and attention to detail
Demonstrated ability to maintain confidentiality and handle sensitive information
Proven negotiation and problem resolution skills
Strong time management and organizational skills
Additional / Specific Job Responsibilities:
Sets up and leads meetings pertaining to quality issues
Investigate and draft quality events (QE)
Perform root cause analysis
Collaborate with Quality Assurance to ensure accuracy of QE(s)
Oversees / manages the group email box, providing key responses to questions and concerns
Follows up with necessary staff members to find resolution to identified quality issues
Work with Global Site Services staff or directly with Central Lab contracted vendors to identify or otherwise verify vendor non-compliance
Escalates issues to leadership/appropriate departmental leads to ensure satisfaction of internal and external customers
Familiarize oneself with Global Site Services and Sample Management procedures and procedural updates
Knowledge of PPD's Preclarus® central lab database and/or lab information management system and supporting quality management system(s)
Team with subject matter experts in updating/emending standard operating procedures (SOP)
Advises subject matter experts / departmental leads of quality concerns that may affect SOPs
Track / notate status of quality events and SOPs for Global Site Services and Sample Management
Collaborates with Global Site Services and Sample Management leadership in execution of process improvement implementation
Benefits:
We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!
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.
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.
Accessibility/Disability Access
Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.
*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.
