Chef de projet clinique (f/h/nb)

Siemens Mobility; Saint-Genis-Pouilly; Hybride; EUR 60 000 - 80 000; Plein temps

Résumé du poste

A leading healthcare company is seeking a Clinical Project Manager in Saint-Genis-Pouilly to oversee an oncology PET imaging Phase III trial across multiple EU countries. The ideal candidate will have over 5 years of clinical study management experience and a strong background in managing CROs and budgets. The role offers a diverse and inclusive work environment with opportunities for professional growth.

Prestations

Flexible working options

Professional development resources

Diverse and inclusive work environment

Qualifications

• 5+ years in clinical study management, including 2+ years as CPM/Study Lead.
• Proven ability to manage multiple aspects of clinical trials.
• Solid grasp of regulatory requirements and vendor oversight.

Responsabilités

• Drive execution of oncology PET imaging Phase III trial.
• Manage CROs, vendors, and ensure compliance with timelines and budgets.
• Coordinate project communications with internal and external stakeholders.

Connaissances

Clinical study management

CRO management

Budget management

Risk management

Formation

Life-science degree (BSc or equivalent)

Advanced degree (MSc, PharmD, PhD)

Outils

MS Project

Smartsheet

CTMS

Description du poste

Overview / Aperçu

Join us in healthcare innovation. For everyone. Wherever he is. Durably. Our inspiring and caring work environment fosters a diverse and inclusive community. We encourage professional and personal growth with resources and flexibility to thrive, while valuing performance. We are Siemens Healthineers' Advanced Accelerator Applications Molecular Imaging, a global leader in PET radiotracer production.

Dans le cadre de l'activité d'imagerie moléculaire de Siemens Healthineers, nous faisons partie d’un réseau mondial de 60 sites de radiotraceurs. Siemens Healthineers est le plus grand fournisseur de produits radiopharmaceutiques de diagnostic TEP, délivrant environ deux millions de doses par an à plus de 3 100 centres dans le monde.

Location / Lieu

Mainly at ADAC MI head office in Saint-Genis-Pouilly (01) with teleworking and travel mainly in Europe.

Principalement au siège social d’ADAC MI à Saint-Genis-Pouilly (01) avec possibilité de télétravail et déplacements en Europe.

Role / Poste

We are seeking a hands-on Clinical Project Manager to drive day-to-day execution of an oncology PET imaging Phase III trial, conducted across multiple EU countries and select U.S. sites. Apply now for the position of Clinical Project Manager (h/f/nb) and you will work closely with internal stakeholders, coordinate CROs, vendors, and sites, ensuring timelines, budget, quality, and regulatory compliance are consistently met.

Nous recherchons un Chef de Projet Clinique, expérimenté et agile, pour diriger l'exécution d'un essai clinique de phase III en imagerie TEP oncologique, mené dans plusieurs pays de l'UE et sur certains sites américains. Postulez dès maintenant pour le poste de Chef de Projet Clinique (h/f/nb) et vous travaillerez en étroite collaboration avec les parties prenantes internes, coordonnerez les CRO, les fournisseurs et les sites, en veillant à ce que les délais, le budget, la qualité et la conformité réglementaire soient toujours respectés.

Key Responsibilities / Responsabilités clés

1. Study Planning & Start-up
   • Translate protocol and program objectives into a comprehensive project plan covering timelines, resources, risk-mitigation, and budget.
   • Lead or support CRO/vendor RFPs, selection, contracting, and kickoff—aligning scopes with study goals.
   • Collaborate with regulatory, medical, and data management teams to finalize study protocol, IB, ICF, and operational plans.
   • Coordinate development/review of core study documents: Monitoring Plan, Imaging Manual, Laboratory & Pharmacy Manuals, eCRF/ICF packages, and site-training decks.
2. Trial Execution & Oversight
   • Serve as primary day-to-day contact for CRO and site teams, driving site start-up, radiopharmaceutical logistics, monitoring patient recruitment and data collection.
   • Provide management of a full scope clinical trial project including global trials from start-up through analysis phase.
   • Participate in Investigator meeting planning; develop meeting agendas/materials and conduct presentations.
   • Monitor data quality and query resolution through EDC oversight and clinical review.
   • Oversee central-imaging workflows (image transfer, BICR scheduling, reader training) and partner with data management to integrate imaging endpoints.
   • Track KPIs, milestones, and budget burn-rate; initiate corrective actions with vendors and escalate per governance pathways.
   • Ensure all activities adhere to protocol, ICH-GCP, EU CTR/FDA IND requirements, and internal SOPs.
   • Timely escalation of issues as appropriate to the Clinical Operations Director.
3. Communication & Stakeholder Management
   • Coordinate weekly or bi-weekly project team and vendor calls; issue clear minutes, action logs, and decision registers.
   • Serve as the primary contact for internal stakeholders, CROs, and external partners on study-level operations.
   • Provide concise executive dashboards on timeline, quality, budget, and risk to Directors and senior leadership.
   • Foster strong investigator relationships with Medical Affairs to support recruitment and protocol adherence.
4. Quality, Compliance & TMF
   • Ensure all activities are conducted in line with ICH-GCP, SOPs, and applicable regulatory guidelines.
   • Drive inspection-readiness: TMF completeness, monitoring-visit follow-up, CAPA tracking, and vendor quality oversight.
   • Participate in site-qualification or co-monitoring visits when escalation or training needs arise.
   • Support audit/inspection preparation and response activities, partnering with QA.
5. Financial Management
   • Build and maintain the study budget, including pass-throughs; reconcile CRO invoices, track change orders, and forecast spend.
   • Serve as liaison to Finance, providing accurate accruals and variance explanations.
6. Process Improvement & Knowledge-Sharing
   • Contribute to SOP updates and best-practice toolkits emerging from the Phase III program.

Qualifications & Experience / Qualifications et Expérience

• Life-science degree (BSc or equivalent) essential. Advanced degree (MSc, PharmD, PhD) preferred.
• ≥5 years in clinical study management, including ≥2 years as CPM/Study Lead on interventional trials. Prior CRA and vendor-side exposure desirable.
• Proven ability to manage CROs, budgets, timelines, and risk logs simultaneously.
• Proven track record in international clinical trials, ideally involving imaging or diagnostic endpoints.
• Diverse diagnostic experience including oncology and nuclear medicine.
• Familiarity with radiopharmaceuticals, PET tracer logistics, and imaging endpoints is a strong advantage.
• Strong understanding of clinical trial operations, regulatory requirements, and vendor oversight.
• Solid grasp of ICH-GCP, EU CTR, FDA IND, IRB/EC submission processes.
• Strong written and verbal English; negotiation skills; ability to manage cross-functional teams and external partners. Additional European languages advantageous.
• Ability to work independently in a lean, fast-paced cross-functional environment is desirable.
• Proficiency in project management tools (e.g., MS Project, Smartsheet, CTMS).

Diversity, Equity and Inclusion are strong values we uphold daily. We consider all applications with respect to our values and transparency.