Opis stanowiska
For our client, we are looking for:
Position: Clinical Trial Manager
Location: Warsaw, Poland (Onsite)
Reports to: CEO
Travel: 2-4 days per month
Language Requirements: English and Polish
Job Summary:
We are seeking an experienced Clinical Trial Manager (CTM) to oversee the planning, execution, and completion of complex trials in accordance with regulatory requirements, company goals, and industry best practices. The role involves coordination across various functions, vendor management, and ensuring data integrity and compliance throughout the lifecycle of the study.
Key Responsibilities:
Lead global and regional trials from initiation to completion, ensuring adherence to timelines, budgets, and regulatory standards.
Develop and manage trial protocols, study materials, and regulatory submissions.
Oversee third-party vendors, investigative sites, and patient recruitment efforts to ensure seamless operations.
Monitor trial progress, identify risks, and implement mitigation strategies.
Ensure regulatory and ethical compliance through documentation review and coordination with key stakeholders.
Manage trial budgets, expenditures, and ensure cost efficiency.
Facilitate investigator meetings, site training, and ongoing communications.
Ensure timely reporting of trial 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) preferred.
Experience: 7-10 years of trial management experience, including managerial roles and global trial management.
Regulatory Knowledge: In-depth understanding of global regulatory standards, including those related to industry-specific regulations.
Technical Skills: Proficiency in clinical trial management systems (CTMS), electronic data capture (EDC) systems, and Microsoft Office Suite.
Industry Expertise: Extensive experience in trial processes, preferably within medical or technology-driven sectors.
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 fostering cross-functional collaboration.
Communication & Interpersonal Skills: Strong written and verbal communication, particularly in interactions with cross-functional teams and external partners.
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?
Be part of a team driving innovation in an industry that impacts global markets.
Work closely with highly experienced professionals and researchers in a dynamic field.
Gain valuable international exposure and work experience beyond Poland.
Learn and grow within a fast-paced and challenging environment, with opportunities for cross-functional development.
Benefits & Perks:
Competitive salary and benefits package.
Participation in the Stock Option Plan (SOP) for long-term growth opportunities.
Comprehensive medical care for the employee.
How to Apply: Please submit your resume (in English) to k.kapoor@stepupsearch.com