Astrum

• Project Planning and Management: Develop, implement, and monitor project plans, timelines, and milestones to ensure efficient trial execution.
• Team Leadership: Lead cross-functional study teams, provide guidance, foster collaboration, and support team development.
• Stakeholder Management: Act as the primary point of contact for sponsors and key stakeholders, ensuring effective communication and strong client relationships.
• Regulatory Compliance: Ensure that all project activities comply with ICH GCP, local regulations, and company SOPs.
• Risk Management: Identify potential risks and proactively implement mitigation strategies to maintain project integrity.
• Data Quality Assurance: Oversee data collection and management processes, ensuring high standards of accuracy and reliability.
• Budget Management: Manage project budgets, monitoring actual hours and costs against the budget and projecting activities for the remainder of the project to ensure project profitability and accountability.
• Quality and Compliance: Oversee the initiation, tracking and resolution of CAPA plans for any quality issues identified or re-ported on projects, Drive continuous improvement and quality initiatives across all aspects of project delivery.
• Training and Professional Development: Support the growth of team members through mentoring, training, and performance feedback.

Additional Responsibilities (depending on experience)

• May function as the Lead CRA on clinical trials.
• Assume responsibility for clinical monitoring and site management activities, sufficient clinical operations experience is desirable.
• Provide study-specific training to CRAs assigned to the study.

• Bachelor’s or Master’s degree in life sciences or a related field.
• At least 2 years proven experience as a Project Manager in clinical research, preferably within a CRO environment.
• Strong knowledge of ICH GCP and relevant regulatory requirements.
• Wide-ranging functional knowledge and competency including in-depth knowledge of clinical trial processes.
• Demonstrated ability to lead cross-functional teams and manage complex, multi-site trials.
• Excellent organizational, communication, and interpersonal skills.
• Strong problem-solving abilities with a proactive, hands-on approach.
• Fluency in English and German (written and spoken)
• Available for (inter)national travel if necessary, including overnight stays.

• Flexible working hours through flexitime.
• Competitive salary.
• Employer contribution to company pension scheme.
• Join our dynamic company for diverse development opportunities within a supportive team and streamlined structure.
• Enjoy an attractive work environment, flexible hours, and options to work from home or connect with colleagues in person.
• Benefit from training tailored to your experience, a dedicated contact person, and regular opportunities for advancement.
• Your ideas for process improvement are encouraged and valued.