Global Clinical Trial Lead – FSP, Oncology or Inflammation

This is a fully remote position, open to applicants in Germany.

📋 Description

• Oversee the setup, execution, and successful delivery of assigned phase 3 clinical trials in Oncology or Inflammation.

• Provide guidance and direction to the trial team to ensure the overall success of the trial in meeting milestones and key performance indicators (KPIs).

• Manage the planning, implementation, tracking, risk mitigation, and communication regarding trial status.

• Develop operationally feasible timelines and supervise the trial preparation process.

• Assist in the creation of trial-level documents across various functions.

• Confirm country allocations and supervise trial feasibility assessments.

• Create and execute engagement plans, recruitment strategies, and risk mitigation plans.

• Lead the development of essential trial and patient-facing documentation.

• Maintain oversight of trial operations, ensuring adherence to Good Clinical Practice (GCP), regulatory compliance, Standard Operating Procedures (SOPs), and risk monitoring.

• Assist in budget oversight, clinical quality monitoring, Safety Monitoring Committee (SMC)/Data Monitoring Committee (DMC) management, and safety reporting.

• Prepare and implement amendments to core documents and updates for training purposes.

• Support responses to regulatory authorities and ethics committees.

• Oversee the outsourcing of vendor services, including Central Lab services.

• Ensure the timely cleaning and delivery of clinical trial data.

• Collaborate with the trial medical writer on the Clinical Trial Report.

• Ensure the thorough and compliant archiving of global documents in the Trial Master File (TMF).

• Facilitate global registry disclosure and the potential publication of trial data.

⛳️ Requirements

• A minimum of 5 years of relevant experience in clinical trial management.

• Strong expertise in clinical trial project management.

• Comprehensive understanding of project management, focusing on teamwork and fostering high-performance teams.

• Experience in the fields of Oncology and/or Inflammation.

• Extensive experience in managing clinical trial projects across international studies.

• A Master's degree is preferred, though not mandatory.

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Comprehensive health and wellness benefits.

• Opportunities for professional development and career advancement.

• Flexible work arrangements to promote work-life balance.