Work Schedule
Standard (Mon-Fri)
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.
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Location/Division Specific Information
Our clinical department defines, develops and delivers clinical programmes. We ensure the highest-quality review of data and effective interaction with study sites, including on-site monitoring throughout a study, ensuring that patients receive needed care, as well as identifying and treating clinical trial participants.
Discover Impactful Work:
Our Danish office consists of colleagues with in-depth therapeutic experience, people with various educations within life science and both newly educated people plus people with years of experience. All in all, we have a very dynamic environment where initiative, flexibility, responsibility, commitment, and fun are in focus.
A day in the Life:
- Performs PPD clinical research services investigator file reviews and logging of outstanding issues in project related tracking tools
- Reviews regulatory documents for proper content
- Liaises with monitor and investigative sites to resolve outstanding regulatory issues identified
- Disseminates study related information, including project tracking updates to Clients, clinical study teams and other PPD clinical research services departments
- Assists with the identification of potential investigators and development/distribution of initial protocol packets
- May assist the project team with the preparation of regulatory compliance review packages
- Builds meeting agendas and minutes, as well as coordinates team conference calls and distribution of meeting minutes
Keys to Success:
Education
- University degree, or equivalent in education, training and experience
Experience
Responsible for adhering to Good Clinical Practices, country specific regulations, PPD clinical research services /Client Standard Operating Procedures and Working Practice Documents regulations for all non-clinical/clinical aspects of project implementation, execution, and closeout
- Ability to effectively analyze project specific data/systems to ensure accuracy and efficiency
- Experience in start-up phase, preferably with EU CTR/CTIS
- Experience of manage multiple projects with differing priorities at one given time
- Outstanding communication, collaboration, interpersonal and time management skills
- Excellent command of Danish and English language
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.