Director Clinical Operations, Trial Management and Oversight (m/f/d) at CatalYm

Planegg, Bavaria, Germany -

Full Time

Start Date

Immediate

Expiry Date

22 Sep, 26

Salary

140000.0

Posted On

24 Jun, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Trial Management, Good Clinical Practice (GCP), Clinical Trial Regulations, Data Management, Budget Management, Leadership, Risk Assessment, Protocol Deviation Management, Vendor Management, Cross-functional Coordination, Analytical Thinking, Interpersonal Communication

Industry

Biotechnology Research

Description

Your mission Director Clinical Operations is responsible for the management and oversight of one or more complex clinical trials, from planning through execution and reporting. Key Responsibilities: Develop and implement strategies for the assigned clinical trials Oversee the set- up and conduct of clinical trials to ensure compliance with the clinical trial protocol and overall clinical objectives and inspection readiness Lead/manage the CatalYm Trial Team including cross-functional alignment concering delieverables, timelines and quality (Medical Services, Regulatory Affairs, Trial Supplies, Bioanalytics, Project Management, Clinical Safety) Oversee the performance of clinical Sites and Service Providers Manage trouble-shooting and shortcomings of Service Providers and Clinical Sites and timely escalation to Senior Management Drive the establishment of the trial-specific risks, hold regular risk assessment meetings, implement mitigations, corrective and preventive actions Manage the protocol deviation (PD) management process, develop and implement the Protocol Deviation Management Plan, hold regular meetings, and implement actions derived from the ongoing assessment of PDs Contribute to the selection and negotiations/contracting with Service Providers Prepare and managing budgets for the assigned clinical studies Ensure data quality and integrity through regular review and evaluation of all clinical data Prepare and present regular updates and reports to senior management Manage the relationship with Investigators /Site trial teams in close cooperation with the Medical Lead Develop and implement trial-specific Sponsor Oversight and Communication Plan, and the Blinding / Unblinding Plan (if applicable) Manage the development and review of trial-related documentation including case report forms, functional plans, manuals, charters, and patient information / informed consent forms Ensure all (serious) adverse events are reported appropriately and in a timely manner Collaborate with various departments and Service Providers to ensure trials are completed on time and within budget Organize activities and stakeholders in context of database closure, interim and final analysis and reporting Oversee the topicality, completeness and correctness of the Trial Master File Oversee the closure of the assigned clinical trials including final budget reconciliation and archiving Your profile Qualifications Proven work experience as a Clinical Trial Manager for complex trials Excellent understanding of Good Clinical Practice (GCP) guidelines Knowledge of clinical trial regulations, guidelines and ethical standards to ensure compliance at all stages of the trials Knowledge of data management, statistical and reporting principles in clinical trials Excellent organization and planning skills to manage all aspects of a clinical trial, from the design stage to the final report writing, and archiving Ability to multitask and manage multiple contributors/stakeholders at the same time Strong leadership and team management skills to coordinate multidisciplinary teams and ensure that all team members are on the same page Attention to details and analytical thinking to ensure accurate data collection, interpretation and reporting Problem-solving skills to address any issues or complications that may arise during all stages of the trials Excellent interpersonal and communication skills At least BSc degree or comparable education in Life Science or related field. Why us? Contribute directly to the success of cutting-edge oncology programs. Be part of an agile, collaborative biotech environment with visible impact. Enjoy flexibility, ownership, and professional growth within a supportive culture. About us CatalYm is a biotech company based in Martinsried near Munich, developing innovative immunotherapies to transform cancer patients’ lives by effectively engaging their own immune systems to combat this malignant disease. We are now advancing to Phase 2b studies to confirm visugromab, our lead antibody, that has demonstrated durable anti-tumor efficacy with long-lasting objective responses in relapsed and refractory metastatic solid tumor patients in combination with anti-PD-1 treatment. Our mission is to rapidly bring our next-generation immuno-oncology products to patients in need. Are you ready to board the fast-accelerating visugromab train in Martinsried? Then join us!

Responsibilities

Responsible for the management and oversight of complex clinical trials from planning through execution and reporting. This includes leading cross-functional teams, managing service providers, and ensuring compliance with protocols and regulatory standards.