Project Coordinator Quality management
Project Coordinator Quality management
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1 Vacancy
Job Description
Work Schedule
Standard (MonFri)Environmental Conditions
Some degree of PPE (Personal Protective Equipment) required (safety glasses gowning gloves lab coat ear plugs etc.Job Description
At Thermo Fisher Scientific youll 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 lifechanging 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.
Division Specific Information:
Our PPD Laboratory Services team has a direct impact on improving patient health through the expertise of scientists industry thought leaders and therapeutic experts. As the world leader in serving science our laboratory professionals bring their commitment to accuracy and quality to deliver groundbreaking innovations.
Title: Labs Project Manager I
Dept.: Lab Operations/ Global Central Labs
Location: Highland Heights KY Office based
Summarized Purpose:
Join Thermo Fisher Scientific Inc. as a Labs Project Manager I and manage projects collaborate with professionals and implement innovative solutions to improve processes within the Global Central Lab! This position will be work onsite at the Lab in Highland Heights KY.
A day in the life:
- Provide oversight and coordination of project initiation ensuring seamless project startup.
- Review interpret translate and program study protocols into a complete and accurate database.
- Communicate with internal departments and external vendors to ensure project requirements are clearly understood agreed upon and followed.
- Ensure smooth communication of technical and clinical laboratory information to collaborators including investigational sites sponsors and nontechnical personnel.
- Consult with laboratory management and technical staff to assist clients in managing clinical trials.
- Prepare study specifications documents maintaining accurate version controls for specs budgets and contracts.
- Ensure compliance with FDA and Good Clinical Practice guidelines company SOPs and other relevant regulations.
- Educate investigator sites by delivering protocolspecific lab procedures presentations.
- Collaborate with IT and data management teams to design validate and implement new software and functionalities.
- Mentor and train junior personnel identifying areas for development and efficiency improvements.
Education
- Bachelors degree or equivalent and relevant formal academic / vocational qualification
Experience
- Previous experience that provides the knowledge skills and abilities to perform the job (comparable to 0 to 2 years) or equivalent combination of education training & experience.
- Years of experience refers to typical years of related experience needed to gain the required knowledge skills and abilities necessary to perform the essential functions of the job. Years of experience are not to be used as the only determining factor in establishing the job class or making employment election decisions.
Knowledge Skills Abilities
- Ensures laboratory compliancewith organization policies and procedures as well as CAP and CLIA guidelines.
- Good organizational skills with the ability to adapt and adjust to changing priorities and to manage multiple assignments with challenging/conflicting deadlines
- Evaluates QC standards to ensure the accuracy of analytical results.
- Effective project management and organizational skills
- Good computer skills
- General knowledge of clinical trial processes and programs
- Strong attention to detail and problem solving skills
- Good written and verbal communication skills
- Ability to effectively conduct oral presentations
- Demonstrated experience in identification and resolution of technical problems in a professional environment
- Ability to maintain a high degree of confidentiality with clinical teams
- Ability to attain maintain and apply a working knowledge of applicable procedural documents
- Demonstrated positive attitude enthusiasm toward work and the ability to work well with others
Work Environment
Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:
- Able to communicate receive and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
- Able to work upright and stationary and/or standing for typical working hours.
- Able to lift and move objects of 15 to 40 pounds
- Able to work in nontraditional work environments.
- Able to use and learn standard office equipment and technology with proficiency.
- May have exposure to potentially hazardous elements including infectious agents typically found in healthcare or laboratory environments.
- Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
- Exposure to fluctuating and/or extreme temperatures on rare occasions
Benefits
We offer competitive remuneration annual incentive plan bonus healthcare and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative forwardthinking organization and outstanding career and development prospects. We offer an exciting company culture that stands for integrity intensity involvement and innovation!
Required Experience:
IC
Employment Type
Full-Time
