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Are you a clinical research professional looking to make a significant impact in the world of Electrophysiology and Cardiology? Join a global leader in MedTech and play a pivotal role in bringing life-changing technologies to patients worldwide. This is your chance to manage complex, international clinical trials within a dynamic environment that values innovation, collaboration, and your professional growth. As a Senior Clinical Research Specialist, you will be the driving force behind the execution of company-sponsored clinical trials. You will oversee the entire study lifecycle—from initial feasibility and site selection to conduct and final closure—ensuring every milestone is met with precision and compliance. This role is a perfect blend of project management, site interaction, and strategic data review, allowing you to function as a trusted expert within the Clinical R&D Department.
Job Responsibility:
Manage the set-up, conduct, and closure of clinical trials in accordance with ICH-GCP, MDR, and company SOPs
Serve as the primary contact for clinical trial sites and foster strong relationships with investigators, IRBs/ECs, and external vendors
Contribute to the creation of essential study documents, including protocols, informed consents, CRFs, and monitoring plans
Oversight of Clinical Research Associates (CRAs) and performing site visits (qualification, initiation, monitoring) as required by study needs
Perform clinical data reviews for statistical analysis and potentially act as a Clinical Safety Coordinator to manage adverse event reporting and safety management plans
Lead small study teams to deliver milestones on time and within budget, while mentoring junior team members
Requirements:
Minimum of a Bachelor’s degree in Life Sciences, Nursing, or a related Biological science
BS with 4+ years, MS with 3+ years, or a PhD with 2+ years of relevant clinical research experience
A strong background in the pharmaceutical or MedTech industry is required
Specific experience in Cardiology or Electrophysiology is highly preferred
Deep knowledge of ICH-GCP guidelines and global clinical trial regulations
Fluent in English (written and oral)
proficiency in other European languages is a distinct advantage
You are proactive, assertive, able to prioritize effectively, and thrive in a collaborative team environment
Willingness to travel approximately 20-25% for site visits and international collaboration
Nice to have:
Specific experience in Cardiology or Electrophysiology is highly preferred
proficiency in other European languages is a distinct advantage