Global Clinical Trial Leader

As a part of the global Project Leadership group at Parexel, you are responsible for leading cross-functional teams to deliver high-quality and patient-focused clinical trials and help bring life-changing treatments to market faster. You collaborate with clients and internal stakeholders to identify project requirements, develop project plans, and manage project timelines and budgets. The role requires strong leadership and communication skills, the ability to work under pressure, and a passion for improving patients' lives. We are seeking a Global Clinical Trial Leader (CTL) to join our team in a remote capacity in Austria. As a Clinical Trial Leader, you will support clinical research activities that advance new treatments for patients. This position plays a key role in study execution, patient safety oversight, regulatory compliance, and clinical data accuracy. You’ll collaborate with cross-functional teams, follow industry-standard processes, and contribute to study operations from planning through closeout. Responsibilities include managing the planning, implementation and tracking of the clinical trial processes as well as risk mitigation, with opportunities to deepen your expertise and influence study outcomes.

Responsibilities

Accountable for the accurate planning and operational feasibility of trial timelines; and oversight of trial preparation to ensure trial team members are aligned and on track; Supports development of trial level documents owned by other functions (e.g. Statistics, Data Management, Study Physician, Medical Writing, Site Monitoring); Verifies and provides input into the country allocation and oversees trial feasibility; Accountable for development and implementation of trial level engagement plans, recruitment planning and risk mitigation; Leads development of core trial and patient facing documents; Maintains oversight during clinical trial conduct including adherence to GCP and all global and local regulatory requirements, compliance with SOPs and continuous risk monitoring/mitigation; In collaboration with other functions, ensures budget oversight, including support of regular clinical quality monitoring, SMC/DMC management and safety reporting; Prepare and implement amendments of core documents, including training material updates/retraining as needed; Support authority/ethics response to requests as applicable; Maintain oversight of outsourcing of vendor services (including Central Lab) in conjunction with other functions; In collaboration with other functions, ensures timely cleaning and delivery of clinical trial data; Coordinates and supports trial medical writer in providing the CTR; Responding for timely, complete and compliant archiving of all relevant global documents in the TMF, including all required documents from vendors; Support results/documents disclosure of global registries; May support publication of trial data

Requirements

Degree (master’s is preferred); Minimum of 5 years’ experience in clinical trial management; Strong clinical trial project management experience; In depth understanding of project management with an emphasis on teamwork, to promote high performance teams; Knowledge of ICH-GCP, regulatory requirements, and clinical trial processes; Strong communication, organization, and problem-solving skills; Fluency in English, both written and spoken; Extensive experience in clinical trial project management across international trials; Global experience working in clinical research, healthcare, or a regulated environment; The ability to collaborate across teams and communicate clearly; A patient-focused mindset and strong attention to detail; Adaptable; Communicator; Collaborative; Leadership; Proactive; Problem-solver

Nice to have

Master’s degree; Experience in either Oncology, CNS, Immunology or Vaccines

Benefits

Supportive work environment; High degree of empowerment and accountability; Flexible work arrangements; Varied project experience; Career progression; Continuous learning opportunities; Encouraged to take on new challenges and pursue interests