Clinical Trial Coordinator II (m/f/d) - Germany

IT-Systemhaus der Bundesagentur für Arbeit; Karlsruhe; Vor Ort; EUR 40.000 - 60.000; Vollzeit

Zusammenfassung

A global biotechnology company is seeking a Clinical Trial Coordinator II in Germany. The role involves managing clinical trial regulations, collaborating with teams, and ensuring compliance across projects. Ideal candidates will hold a university degree in life sciences and be proficient in German and English. This position offers a structured work environment to improve health outcomes globally, with a commitment to individual career development through training and support.

Qualifikationen

• Must adhere to Good Clinical Practices and country specific regulations.
• Experience managing multiple projects with differing priorities.
• Excellent communication skills are essential.

Aufgaben

• Perform investigator file reviews and track issues.
• Resolve outstanding regulatory issues with study sites.
• Assist with regulatory compliance review packages.

Kenntnisse

Ability to analyze project specific data

Outstanding communication skills

Teamwork

Interpersonal skills

Time management skills

Fluent in German (C1 level)

Fluent in English

Ausbildung

University degree in life sciences

Jobbeschreibung

Clinical Trial Coordinator II (m/f/d) - Germany

Clinical Trial Coordinator II (m/f/d) - Germany

Beginn

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.

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:

PPD clinical research service`s mission is to improve health. It starts as an idea to cure. It becomes a life saved. All in-between, it’s you! We know that meaningful results not only require the right approach, but also the right people. We invite you to re-imagine health promoting protocols with us, working alongside our dedicated, forward-thinking and upbeat teams.

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 in life sciences, or equivalent in education, training and experience

Knowledge, Skills, Abilities

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 analyse project specific data/systems to ensure accuracy and efficiency
• Experience of manage multiple projects with differing priorities at one given time
• Outstanding communication, teamwork, interpersonal and time management skills
• Excellent German (C1 level) and English languages

Severely disabled applicants with the same aptitude will be given preferential treatment. / Schwerbehinderte Bewerber werden bei gleicher Eignung bevorzugt behandelt.

Thermo Fisher Scient. Ger. B.V. & Co. KG