Clinical Project Manager (CPM) (f/m/d)
Clinical Project Manager (CPM) (f/m/d)
Clinical Project Manager (CPM) (f/m/d)
Clinical Project Manager (CPM) (f/m/d)
Siemens AG
Industrie und Maschinenbau
München
- Art der Anstellung: Vollzeit
- Vor Ort
- Zu den Ersten gehören
Clinical Project Manager (CPM) (f/m/d)
Über diesen Job
Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably.
Advanced Accelerator Applications, a Siemens Healthineers company, is a global leader in the production of PET radiotracers. With over two decades of expertise, we are committed to delivering high-quality, reliable diagnostic radiopharmaceuticals and services that have established us as a trusted partner in PET imaging.
As part of Siemens Healthineers Molecular Imaging business, we are integrated into a global network of 60 radiotracer production facilities. Siemens Healthineers is the largest supplier of PET diagnostic radiopharmaceuticals, delivering approximately two million doses annually to more than 3,100 imaging centers worldwide.
At Advanced Accelerator Applications, we believe in fostering an inclusive, diverse, and collaborative environment where every individual is valued. We encourage personal and professional growth, offering opportunities to step outside your comfort zone while providing the resources and flexibility to thrive. Join us to make a meaningful impact on global healthcare and be part of a team dedicated to shaping the future of medical imaging.
Apply now for the position of Clinical Project Manager (CPM) (f/m/d). You will lead the operational execution of a Phase III oncology PET imaging trial across EU and U.S. sites. As the study’s central coordinator, you’ll work closely with internal teams and oversee CROs, vendors, and sites to ensure timelines, budget, quality, and compliance. We’re looking for someone with imaging trial experience, strong vendor management skills, and the ability to thrive in a lean, mission-driven radiopharma environment.
Your role:
Study Planning & Startup
- You will translate protocol into a project plan with timelines, resources, risks, and budget.
- You will manage CRO/vendor selection, contracting, and kickoff.
- You will finalize study documents (protocol, IB, ICF) with internal teams.
- You will coordinate the development of operational materials (e.g., Monitoring Plan, Imaging Manual, eCRF, training decks).
Trial Execution & Oversight
- You will act as main contact for CROs and sites; oversee startup, logistics, recruitment, and data.
- You will manage trial activities from startup to analysis.
- You will support Investigator Meetings and presentations.
- You will monitor data quality and imaging workflows.
- You will track KPIs, budget, and timelines; escalate issues as needed.
- You will ensure compliance with ICH-GCP, EU CTR/FDA IND, and SOPs.
Communication & Stakeholder Management
- You will lead regular team/vendor calls; you will document actions and decisions.
- You will act as an interface with internal and external stakeholders.
- You will provide executive updates on progress, risks, and budget.
- You will support investigator engagement with Medical Affairs.
Quality & Compliance
- You will ensure inspection readiness and TMF completeness.
- You support site visits, audits, and CAPA tracking.
Financial Management
- You will build and manage study budget; you reconcile invoices and forecast spend.
- You will liaise with Finance for accruals and variance reporting.
Process Improvement
- You will contribute to SOPs and best practices from the Phase III program.
Your expertise:
- A degree in Life Sciences (BSc or equivalent) is essential, while an advanced degree (MSc, PharmD, or PhD) is preferred.
- You have several years of experience in clinical study management, including experience as Clinical Project Manager or Study Lead on interventional trials. Prior experience as a Clinical Research Associate (CRA) and exposure to vendor-side operations are highly desirable.
- Demonstrated ability to manage CROs, budgets, timelines, and risk logs simultaneously is expected.
- You have a proven track record in managing international clinical trials, ideally involving imaging or diagnostic endpoints.
- Broad diagnostic experience, including but not limited to oncology and nuclear medicine, is preferred.
- Familiarity with radiopharmaceuticals, PET tracer logistics, and imaging endpoints is considered a strong advantage.
- A solid understanding of clinical trial operations, regulatory requirements, and vendor oversight is required.
- Comprehensive knowledge of ICH-GCP, EU CTR, FDA IND, and IRB/EC submission processes is essential.
- Excellent written and verbal communication and negotiation skills in English, along with the ability to manage cross-functional teams and external partners, are required. Fluency in additional European languages is highly advantageous.
- You are proficient in project management tools such as MS Project, Smartsheet, and CTMS.
- You work independently in a lean, fast-paced, cross-functional environment.
To find out more about the specific business, have a look at Advanced Accelerator Applications Molecular Imaging - Siemens Healthineers
Who we are:
We are a team of more than 73,000 highly dedicated Healthineers in more than 70 countries. As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing. Our portfolio is crucial for clinical decision-making and treatment pathways.
How we work:
When you join Siemens Healthineers, you become one in a global team of scientists, clinicians, developers, researchers, professionals, and skilled specialists, who believe in each individual’s potential to contribute with diverse ideas. We are from different backgrounds, cultures, religions, political and/or sexual orientations, and work together, to fight the world’s most threatening diseases and enable access to care, united by one purpose: to pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably. Check our Careers Site at https://www.siemens-healthineers.com/de/careers
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