Senior Manager Clinical Operations

Stockholm, Sverige eller Leiden, Nederländerna

Are you a passionate Clinical Project Leader with oncology experience? Can you envision using your expertise to impact patients’ lives? Join our Clinical Operation department to make a purposeful difference! At Mendus we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. You have good knowledge of project management and have excellent communication skills and fluent in English. An inclusive culture that champions diversity and collaboration. Always committed to lifelong learning, growth and development. You will be responsible for the management of clinical study project(s) and report to the Director Clinical Operations.

We are now looking for a dedicated Manager Clinical Operations that will have these responsibilities:

  • Managing and leading all aspects of clinical study projects from study planning to close-out and study report
  • Selection and oversight of performance of Clinical Research Organizations (CROs) and other vendors
  • Oversight and regular reporting of study progress to ensure successful completion within agreed timelines/ milestones and budget
  • Study site selection and performance and participation in site visits, as applicable
  • Participate in establishing, monitoring, and maintaining procedures (SOPs) to ensure program meets all ICH/GCP Guidelines and is Inspection Ready
  • Support maintaining relationship with KOLs and PIs
  • Organizing and participating in internal and external meetings as required
  • Co-development and review of study documents e.g., study protocol, informed consent form, monitoring guidelines, study manuals, Case Report Forms, regulatory authority submissions
  • Routinely review of study data and progress of EDC entry; working with data management and clinical sites to resolve data discrepancies

Requirements:

  • Early- Mid-phase global drug development experience (phase I-III)
  • CRO selection & management experience
  • 5+ years in clinical project/trial management
  • Experience in oncology, preferably with immunotherapy and cell therapy
  • Degree in pharma, life-science or health related studies
  • Vendor oversight experience
  • Deep knowledge about ICH-GCP and other relevant regulation to conduct clinical trials
  • Knowledge of IND/CTA submission to FDA and other competent authorities
  • Experience of contract and budget negotiations with CROs, vendors and sites
  • Proficient in MS Word, Excel and Power Point
  • As a person, you have an analytical mindset and maintains a high ethical standard. You are a positive, result-driven, team-oriented, agile individual with the ability to influence outcomes. Excellent organizational, communication and time management skills needed to manage multiple ongoing activities simultaneously.

This position can be placed in Stockholm in Sweden or in Leiden, the Netherlands.

For questions regarding the position, please contact the company’s Director Clinical Operations, Petra Domeij, via email: petra.domeij@mendus.com. Please send your application containing personal letter and CV to HR@mendus.com.

The recruitment process is managed by Mendus so recruitment companies are excluded.