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Associate Clinical Trial Manager(m/w/x)

Miltenyi Biotec
Bergisch Gladbach

You manage activities at clinical trial sites, ensuring compliance and successful enrollment while collaborating with various teams to enhance processes and maintain essential documentation.

Anforderungen

  • •Proactive and communicative team player
  • •Academic background in life sciences
  • •Strong organizational and communication skills
  • •Fluent in English and German
  • •Confident in using MS Office
  • •Experience with clinical trial systems
  • •Willingness to travel and engage with clinical sites
  • •Previous experience in hemato-oncology

Deine Aufgaben

  • •Serve as the main contact for assigned clinical trial sites.
  • •Coordinate activities from start-up to close-out.
  • •Support operational plans, site training, and study materials.
  • •Ensure protocol compliance and successful enrolment.
  • •Monitor study progress and contribute to enrolment strategies.
  • •Escalate issues or delays to the Clinical Trial Manager.
  • •Review and manage essential trial documents.
  • •Maintain the Trial Master File (TMF) and ensure compliance.
  • •Collaborate with cross-functional teams on process improvements.
  • •Create and revise standard operating procedures (SOPs) and templates.

Deine Vorteile

Flexible time management
Diverse intercultural environment
Creative contribution freedom
Individual training opportunities
30 days of vacation
Discounted ticket to Germany
(E)-bike leasing
Capital-forming benefits
Company pension plan
Disability insurance
Canteen services
Additional benefits

Original Beschreibung

## Job Description As an Associate Clinical Trial Manager, you will support the Clinical Trial Manager in ensuring the successful planning, execution, and oversight of clinical trials at the country level. Your contribution will be essential to maintaining high-quality standards and meeting project timelines. * Act as the primary point of contact for specific assigned clinical trial sites, coordinating all activities from start-up to close-out, including CRO oversight. * Support the development and implementation of operational plans, site trainings, and study materials to ensure protocol compliance and enrolment success. * Monitor study progress, contribute to enrolment strategies, and escalate issues or delays to the Clinical Trial Manager or Group Leader as needed. * Review and manage essential documents (e.g. protocols, informed consent forms), support Trial Master File (TMF) maintenance, and ensure GCP and SOP compliance. * Collaborate with cross-functional teams (e.g. regulatory affairs, medical affairs, quality assurance, logistics, manufacturing, and many more) and contribute to process improvements, including the creation and revision of SOPs and templates. ## Qualifications * We are looking for a proactive and communicative team player with a strong interest in clinical research and operational excellence. You thrive in a dynamic environment and bring a structured, solution-oriented mindset. * Academic background in life sciences, natural sciences, medicine, or a related field and proven experience in clinical research or clinical trial coordination, ideally with exposure to Medical Affairs, Clinical Operations, or related functions. * Strong organizational and communication skills, with the ability to manage multiple priorities and collaborate across teams. * Fluent in English and German; every other European language like French, Spanish, etc is a plus. Confident in using MS Office and clinical trial systems (e.g. CTMS, eTMF). * Willingness to travel and engage with clinical sites and stakeholders; previous experience in hemato-oncology, or cell therapies is highly valued. ## Additional Information **What we offer** * Working with free and self-determined time management, also mobile working * An intercultural environment characterized by diversity and flat hierarchies * Freedom to contribute creatively and play an active role in shaping the company * Individual further training in our Miltenyi University as the core of the Miltenyi DNA * 30 days of vacation, discounted ticket to Germany, (e)-bike leasing, capital-forming benefits, company pension plan, disability insurance, canteen, and much more. **Diversity is the bedrock of our creativity** Our mission: To innovate treatments and technologies and tackle the world’s most serious health challenges. And that’s why we connect the dots – across various disciplines, linking different perspectives, skills, and abilities. You and your talent are welcome here in our inclusive and collaborative environment. So come as you are. Regardless of gender, sexual identity, age, ethnicity, religion or disability. Become part of our team and focus on pushing the borders of medicine.
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