Senior Clinical Research Associate (Sr CRA II)

Placering
Copenhagen
Fjernarbejde
Hybrid
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.

Our clinical department defines, develops and delivers clinical programmes. Our global Clinical Operations colleagues within our PPD® clinical research services provide end-to-end support for clinical trials from study start up to monitoring through to study close out, across commercial and government contracts. Together, we help clients define and develop clinical programs, minimize delays, and implement high-quality, cost-efficient clinical studies.

Honed by decades of experience, shaped by a culture of innovation, PPD will give you greater certainty and faster traction.

Our Accolades Reflect Our Mission:

• Recognized for excellence in various categories in the 2023 CRO Leadership Awards: access to patient populations, data management and patient recruitment and for compatibility, including responsiveness, project communications and customer service. In addition, we were recognized for reliability and expertise.
• Named “Best Lab” at the 2023 Vaccine Industry Excellence (ViE) Awards
• Named a 2023 Training magazine APEX Award winner for effective employee development programs.
• Thermo Fisher Scientific’s Clinical Research Business Named “Best CRO”
• Recognized by ISG for digital services leadership
• Winner of the 2022 TOPRA Award for Regulatory Excellence with Moderna for work on a COVID-19 vaccine authorization
• Named to BioSpace’s 2023 Best Places to Work list
• Named “Clinical Research Company of the Year” at the 2022 PharmaTimes Clinical Researcher of the Year-The Americas competition

Learn more by visiting https://www.ppd.com/

Your Role:

• Performs and coordinates all aspects of the clinical monitoring and site management process in compliance with the Regulatory approved Protocol and Monitoring Plan.
• Conducts remote or on-site visits to assess protocol and regulatory compliance and handles required documentation.
• Manages procedures and guidelines from different sponsors and/or monitoring environments (i.e. FSO, FSP, Government, etc.).
• Develops collaborative relationships with investigational sites.
• Acts as a site Manager and processes specialist, ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs to guarantee subjects rights, well-being and data reliability.
• Ensures audit / Inspection readiness.
• Detailed tasks and responsibilities assigned to role are outlined in the task matrix.

Your Qualifications

• Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification. In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
• Valid driver's license
• Effective clinical monitoring skills with at least 5 year of monitoring experience
• Effective oral and written communication skills in Danish and English with the ability to communicate optimally with medical personnel and colleagues.
• Ability to travel and perform 8 days on Site per month on average.
• Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
• Excellent understanding and demonstrated application of ICH GCPs, applicable regulations and procedural documents.
• Ability to handle Risk Based Monitoring concepts and processes.
• Strong attention to detail and time management skills
• Good computer skills: proficient knowledge of Microsoft Office and the ability to learn appropriate software
• Good presentation skills

*Please submit your CV in English

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.