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Global Project Manager
Company: Prima BioMed is a global leader in the development of personalized immuno-oncology products. Our lead program is CVac for the maintenance treatment of ovarian and pancreatic cancer patients in remission. The company is publically traded on the ASX and NASDAQ.
Location: Berlin, Germany
Reporting: Global Medical Director
Overall Job Responsibilities:
  • Plans, execute, and coordinate all aspects of the project in order to maintain schedule, budget and quality in accordance with project requirements
  • Operational management of global clinical trials, including selection and oversight of outsourced partners, consultants, and vendors

Job description:
  • Act as global Project Manager on CVac™ development program, and other programs as assigned
  • Provide matrix interaction with individuals from regulatory affairs, (pre-)clinical development, CMC, business development and other scientific and business related disciplines to ensure project goals are achieved
  • Management and oversight of CROs, clinical study teams and vendors to ensure that studies are completed on time, within budget, and in compliance with SOPs and relevant regulations (FDA, EMA, ICH)
  • Assure a robust document trail for clinical trial operations, monitoring, etc.
  • Implement programs and tracking tools to ensure goals are achieved
  • Maintain project plans
  • Prepare reports for senior management on project status, milestones, budget implications, and other metrics as requested
  • Analyze business conditions to determine present and future needs to staff and execute clinical trials
  • Identify business improvement opportunities and participate and/or lead in creating solutions which improve clinical trial efficiency and effectiveness
  • Other duties as assigned
Required Skills/Experience:
  • PhD or MSc in Biochemistry, Biology, Pharmaceutical sciences or a related field and 8+ years of project management experience in the biotech field
  • Ability to manage complex projects, handle multiple tasks simultaneously, and to switch between tasks quickly
  • Must have working knowledge of international (FDA, EMA) regulations, GCP, PhRMA principles and guidelines, and similar compliance requirements
  • Proficiency in the implementation, monitoring, and management of global clinical trials
  • Excellent technical/medical writing skills (English)
  • Strong interpersonal and negotiation skills
  • High energy level and strong self‐motivation
  • Proficiency with MS Word, Excel, Outlook, PowerPoint and Microsoft Project
  • Must be willing to travel as required for the project (approx. 10 – 25 %)
Preferred Skills/Experience
  • Oncology experience preferred, although not essential.
  • More than 5 years of project or study management with responsibility for global clinical trials
  • Project management certification or MBA
  • Competitive salary and benefits package, commensurate with experience
  • Relocation assistance can be provided for exceptional candidates
Prima BioMed is an equal opportunity employer committed to hiring a diverse workforce.


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Details der Stellenanzeige

Bereichs- & Abteilungsleitung
Berufserfahrung vorausgesetzt
Deutschland (Berlin)
10707 Berlin
Biotechnologie, Biologie & Life Sciences