Clinical Development and Operations Support (f/d/m) at CatalYm

Planegg, Bavaria, Germany -

Full Time

Start Date

Immediate

Expiry Date

11 Oct, 26

Salary

70000.0

Posted On

13 Jul, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Calendar Management, Meeting Coordination, Clinical Documentation, GxP, ICH GCP, Microsoft Office, SharePoint, MS Teams, Vendor Management, Regulatory Submission Support, Cross-functional Communication, Administrative Support

Industry

Biotechnology Research

Description

Your mission The Clinical Development & Operations Coordinator (f/d/m) provides dedicated administrative and operational support to the Clinical Development and Clinical Operations functions. This role is ideal for an experienced coordinator who understands the pace, confidentiality, documentation standards and regulated environment of clinical drug development. Acting as the operational backbone of the CMO organization, the coordinator ensures seamless coordination, efficient communication and well-organized execution across Clinical Development, Clinical Operations, Medical Science, Regulatory Affairs and Clinical Safety. By managing schedules, meetings, documentation, trackers and collaboration tools, this role enables teams and leaders to focus on advancing clinical programs. In addition, this role serves as the designated backup for the Executive Assistant, providing administrative support and ensuring business continuity during periods of absence or increased workload. Key Responsibilities Provide high-quality administrative support to Clinical Development, Clinical Operations and Regulatory Affairs leaders, including calendar management, meeting coordination, agenda preparation and follow-up tracking. Coordinate complex cross-functional meetings, including trial team meetings, governance meetings, vendor meetings, Steering Committees, Advisory Boards and leadership reviews. Prepare, organize and distribute meeting agendas, presentations, pre reads, minutes, action logs and follow up summaries. Maintain awareness of key clinical milestones and proactively coordinate meeting cadence and preparation to support timely decision-making. Partner closely with Project Management to support clinical timelines, meeting readiness, action tracking and cross functional communication. Organize, maintain and track clinical documentation in accordance with company standards, GxP expectations and ICH GCP principles. Maintain departmental trackers, contact lists, team calendars, decision logs and other operational tools supporting Clinical Operations. Manage SharePoint sites, document repositories and shared folders to ensure information is accurate, accessible and well organized. Support preparation of regulatory submission materials, inspection readiness documentation, quality documentation and safety-related materials as requested by functional leads. Coordinate vendor interactions, document exchange, operational follow up and meeting logistics as needed. Arrange travel, expense reimbursements, conference registration, off-site meetings and workshops for Clinical Development and Clinical Operations teams. Coordinate administrative processes related to purchase orders, invoices, vendor onboarding, contract routing in collaboration with Finance, Procurement and Legal. Facilitate effective communication across Clinical Development, Clinical Operations, Medical Science, Regulatory Affairs and Clinical Safety. Handle confidential clinical, regulatory, quality, vendor and personnel information with discretion, and professionalism. Continuously identify opportunities to improve administrative processes, documentation workflows, meeting effectiveness and information flow across the CMO organization. Serve as backup to the Executive Assistant by providing administrative support as needed, ensuring continuity of critical business operations during absences or peak workload periods. Clinical Development and Operations Support Develop and maintain a solid understanding of clinical development programs, trial teams and cross-functional clinical workflows. Support clinical trial activities by coordinating documentation, trial start-up materials, enrollment updates, vendor communications and leadership reporting. Assist with preparing materials for governance meetings, executive updates, Board presentations and business reviews. Ensure strong version control, document quality, confidentiality and appropriate access management across all clinical documentation. Your profile Qualifications 3+ years of experience in an administrative, coordinator or team support role, within Clinical Development, Clinical Operations, Regulatory Affairs, or Clinical-Safety in biotech, pharma or clinical research. Experience supporting senior leaders and cross-functional teams in a fast-paced, matrix organization. Working knowledge of clinical trial processes, clinical development terminology, regulated documentation practices and GxP and ICH GCP requirements. Strong proficiency in Microsoft Office (Outlook, Word, Excel and PowerPoint). Experience working with SharePoint, MS-Teams and document management systems. Excellent written and verbal communication skills in English. German is an advantage. Demonstrated ability to manage multiple priorities, maintain confidentiality and deliver high quality work with minimal supervision. Distinct Competencies Outstanding organizational and administrative skills with a proactive, service-oriented mindset. Strong understanding of the operational rhythm and documentation expectations within clinical development. Excellent attention to detail and reliable follow-through. Ability to build effective working relationships across functions, cultures and organizational levels. Strong communication skills with sound judgment on prioritization and escalation. High level of integrity and discretion when handling confidential information. Adaptable, resilient and comfortable working in a dynamic environment with changing priorities. 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

Provide high-level administrative and operational support to Clinical Development, Operations, and Regulatory Affairs teams. Manage schedules, documentation, and cross-functional communication to ensure the seamless execution of clinical programs.