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Job Function:
R&D Operations
Job Sub Function:
Clinical Trial Project Management
Job Category:
Professional
All Job Posting Locations:
Aachen, North Rhine-Westphalia, Germany
Job Description:
The Clinical Project Manager Europe (m/f/d) is responsible for managing the operational activities of assigned clinical studies across the EU/EMEA region. This includes planning, development, execution, and follow-up of clinical trial activities to ensure compliance with GCP/ICH guidelines, EU and FDA (if applicable) regulations, and GDPR requirements.
The role collaborates with Clinical Program Managers, Clinical Research Associates, Medical Affairs, Regulatory Affairs, and cross-functional partners, and interacts with CROs, core laboratories, and study committees.
DUTIES & RESPONSIBILITIES:
-Lead comprehensive study management including protocol and database development, site selection, monitoring oversight, and project planning,
- Chair study team meetings ensuring clear goals, deliverables, decisions, risks, and actions,
- Manage project timelines, performance tracking, and risk mitigation,
- Oversee development of essential study documentation including protocols, amendments, plans, manuals, tools, training materials, ICFs, and clinical study reports,
- Ensure compliance with company SOPs, ICH-GCP, and regulatory requirements,
- Manage project-specific vendors,
- Analyze and resolve site-level, vendor, and administrative issues,
- Plan and participate in Investigator and Research Coordinator meetings,
- Support audits and inspections, including quality assurance readiness,
- Support patient recruitment strategies and enrollment oversight,
- Communicate business-related issues to management,
- Follow all Health, Safety, and Environmental policies,
- Ensure compliance with all corporate and regulatory requirements
EXPERIENCE AND EDUCATION:
- Bachelor's degree in Science, Engineering, Nursing, or a related medical/scientific field required. Master's degree preferred.
- Minimum of 5 years of clinical research experience, including at least 2 years in the medical device industry in a leadership or project management role.
- Experience with pre- and post-market clinical strategies and IDE/510(k) or EU equivalent studies preferred.
REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS:
- Expertise in GCP and regulatory compliance
- Experience with EU regulatory submissions
- Strong written, verbal, and presentation skills in German and English
- High attention to detail with strong prioritization and organizational skills
- Ability to work in fast-paced environments with cross-functional teams
- Advanced project management skills
- Preferred: Experience with Class III cardiovascular devices, FDA or EU inspection experience, PMP or CCRP certification
- Up to 35 % travel required. May require participation in audit-readiness activities and extended hours depending on study needs. Must follow applicable Health, Safety, and Environmental guidelines.
The anticipated base pay range for this position is 75.000 EUR to 118.450 EUR.
In addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees' and companies' performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, and programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location's eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.
*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.
Required Skills:
Preferred Skills:
Analytical Reasoning, Clinical Research and Regulations, Clinical Trial Designs, Clinical Trial Management Systems (CTMS), Clinical Trials, Communication, Data Savvy, Laboratory Operations, Organizing, Problem Solving, Productivity Planning, Professional Ethics, Project Integration Management, Quality Assurance (QA), Regulatory Compliance, Research and Development, Research Ethics, Standard Operating Procedure (SOP)