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Client: Thermo Fisher Scientific
Location: Job Category: Other
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Job Reference: c58e3cf6ea9b
Job Views: 4
Posted: 28.04.2025
Expiry Date: 12.06.2025
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Job Description: At Thermo Fisher Scientific, you will 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.
Essential functions:
Monitors investigator sites with a risk-based monitoring approach, applying root cause analysis (RCA), critical thinking, and problem-solving skills to identify site process failures and implement corrective/preventive actions to ensure compliance and reduce risks. Ensures data accuracy through SDR, SDV, and CRF review during on-site and remote monitoring activities. Assesses investigational products via physical inventory and record reviews. Documents observations promptly using approved business writing standards. Raises deficiencies and issues to clinical management and follows up until resolution. Maintains contact with investigative sites between visits to ensure protocol adherence, issue resolution, and timely data recording. Conducts monitoring as per the approved plan.
Participates in the investigator payment process and collaborates with the project team to resolve issues and findings.
Participates in investigator meetings and collaborates with the client to identify qualified investigators and ensure site acceptability.
Initiates clinical trial sites following relevant procedures, ensuring compliance with protocol, regulatory, and ICH GCP obligations. Performs trial close-out and retrieval of trial materials.
Ensures completeness of essential documents in accordance with ICH-GCP and regulations. Conducts on-site file reviews as per project specifications.
Provides trial status updates and reports to the Clinical Team Manager. Ensures study systems are updated per conventions.
Facilitates communication between investigative sites, the client, and the project team via written, oral, and electronic methods.
Responds to regulatory requirements, audits, and inspections. Maintains administrative tasks such as expense reports and timesheets.
Contributes to project publications, process improvements, and team initiatives.
Education and Experience:
Bachelor's degree in a life science field, Registered Nursing certification, or equivalent qualification.
Approximately 3 years of experience as a clinical research monitor or similar.
Valid driver's license if applicable.
Knowledge, Skills, and Abilities:
Proven clinical monitoring skills and understanding of medical/therapeutic areas and terminology.
Solid knowledge of ICH GCPs, regulations, and procedures.
Strong critical thinking, problem-solving, and risk management skills.
Effective communication skills in English and German; French and Italian are a plus.
Good organizational, interpersonal, and computer skills, with proficiency in Microsoft Office.
Ability to work independently and as part of a team, adaptable to various scenarios.
What We Offer:
At PPD, a part of Thermo Fisher Scientific, we hire top talent, support professional and personal growth, and value diversity. We offer competitive salaries, comprehensive benefits focused on health and well-being, and promote a healthy work-life balance. Our global organization fosters a collaborative environment where colleagues share expertise and enjoy their work. Our mission is to enable our customers to make the world healthier, cleaner, and safer. Join us and #StartYourStory, where diverse backgrounds and perspectives are valued.
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