Local Clinical Study Manager – Eastern Europe

This is a fully remote position, open to applicants in Czechia, +4 more countries.

📋 Description

• Plan and oversee daily operations for monitoring intricate clinical studies.

• Communicate project goals, expectations, and status updates to clinical teams.

• Assume overall responsibility for country study commitments and ensure timely, high-quality data delivery.

• Provide oversight and leadership for clinical deliverables.

• Lead and manage clinical teams along with relevant local and global personnel.

• Facilitate the successful activation of trial sites.

• Monitor the quality of clinical activities and address any quality issues that arise.

• Review and approve site visit reports, ensuring proper tracking, follow-up, and resolution of site-related issues.

• Identify data-related challenges and risks, developing contingency and mitigation strategies.

• Create and maintain project-specific plans, documents, and tools.

• Support Clinical Research Associates (CRAs) with site monitoring tasks and offer solutions to site challenges.

• Supervise regulatory and in-house clinical staff to ensure all necessary updates, reports, renewals, and end-of-study notifications adhere to protocols, local regulations, ICH GCP, and governing procedures.

• Coordinate training, processes, systems-related activities, and ad-hoc tasks.

⛳️ Requirements

• Bachelor’s degree in a relevant field, preferably in life sciences.

• Five or more years of experience in clinical research, with at least 2 years in project management, or a suitable combination of education and experience to effectively fulfill the key responsibilities of this role.

• Strong understanding of international guidelines such as ICH GCP and pertinent local regulations.

• Demonstrated ability to lead and inspire cross-functional teams to deliver clinical trials on or ahead of schedule, within budget, and with the required quality.

• Prior experience in Oncology or Onco-hematology is mandatory.

• Solid knowledge of the Drug Development Process.

• Excellent proficiency in both spoken and written English.

• Strong capacity to learn and adapt to working with IT systems.

• Effective decision-making skills.

• Experience in monitoring study activities for compliance and readiness for inspection.

• Strong interpersonal skills for collaborating with internal teams, stakeholders, and external vendors.

• In-depth understanding of clinical operations processes, including trial data collection and management.

🏝️ Benefits

• Full-time, home-based work environment.

• Opportunity to manage clinical research projects across various therapeutic areas.

• Chance to collaborate closely with a key client.