Opis stanowiska
For our client, who is involved in the creation, development and commercialization of innovative, safe, minimally invasive solutions in the field of medicine, in particular cardiology and cardiac surgery, improving the quality of life, we are looking for people for the position:
Position: Clinical trial manager
Location: Warsaw, Poland (Onsite)
Customer industry: Medical Device
Reports to: CEO
Travel: 2-4 days per month
Language Requirements: English and Polish
Job Summary:
The Clinical Trial Manager (CTM) is responsible for overseeing the planning, execution, and completion of clinical trials in accordance with regulatory requirements, company objectives, and industry best practices. This role involves cross-functional coordination, vendor management, and ensuring the highest level of data integrity and compliance throughout the study lifecycle.
Key Responsibilities:
Lead global and regional clinical trials from initiation to completion, ensuring compliance with timelines, budgets, and regulatory standards (FDA and MDR).
Develop and manage study protocols, trial materials, and regulatory submissions.
Oversee CROs, vendors, investigative sites, and patient recruitment efforts to ensure smooth operations.
Monitor study progress, identify risks, and implement mitigation strategies.
Ensure regulatory and ethical compliance through documentation review and stakeholder coordination.
Manage study budgets, expenditures, and cost efficiency.
Facilitate investigator meetings, site training, and ongoing communications.
Ensure timely reporting of study results, contributing to clinical study reports (CSRs) and publications..
Qualifications & Experience:
Education: Bachelor’s degree in life sciences, nursing, pharmacy, or a related field; advanced degree (MS, PhD, PharmD) preferred.
Experience: 7-10 years of clinical trial management in pharmaceuticals, biotechnology, or medical devices, including managerial roles and global trial experience.
Regulatory Knowledge: Strong understanding of FDA and MDR, and other relevant regulations EMA and ICH-GCP.
Technical Skills: Proficiency in clinical trial management systems (CTMS), electronic data capture (EDC) systems, and Microsoft Office Suite.
Industry Expertise: Extensive knowledge of clinical trial processes, particularly in medical devices and cardiology.
Project Management: Ability to oversee multiple trials across various stages, prioritize tasks, and meet deadlines.
Leadership & Collaboration: Proven leadership experience, including mentoring junior team members and cross-functional teamwork.
Communication & Interpersonal Skills: Strong written and verbal communication, particularly in interactions with medical professionals and stakeholders.
Problem-Solving & Critical Thinking: Ability to identify challenges, develop solutions, and drive decision-making in a fast-paced environment.
Certifications: Clinical research certification (e.g., ACRP, SOCRA) is a plus.
Why Join Us?
Be part of a team developing cutting-edge medical devices that impact patient care globally.
Work closely with world-renowned medical professionals and researchers.
Gain valuable international exposure and experience beyond Poland.
Learn and develop across various functions in a dynamic, fast-paced environment.
Benefits & Perks:
In addition to a competitive salary and benefits, this role includes participation in Stock Option Plan (SOP), providing long-term growth opportunities.
Medical care for the employee.
If you are a detail-oriented and results-driven clinical operations professional looking for an opportunity to lead innovative clinical research initiatives, we encourage you to apply!
How to Apply: Please submit your resume (in English) to k.kapoor@stepupsearch.com