Senior Project Manager in Clinical Pharmacology

Reference Number: 895857-W
Type of placement: Permanent, Permanent
Location: Switzerland, North West

Introduction:

Our client, a Swiss biopharmaceutical company, is looking for a Senior Project Manager in Clinical Pharmacology for a permanent role based in the Basel area, Switzerland.

The ideal candidate should have previous experience in early phase project management and strong knowledge of practical applications of ICH-GCP in the pharmaceutical industry or CRO.

If this opportunity does not match your profile but you know someone who could fit, we offer a highly competitive and attractive referral scheme! Please contact us directly for more details at recruitment@ctcresourcing.com.

Main Responsibilities:

  • Provide operational leadership for assigned Phase I/IIa studies by being responsible for the operational   deliverables, milestones, data quality, and deadlines related to assigned clinical studies from study start to Trial Master File (TMF) archiving
  • Proactively manage changes in the planning and conduct of assigned studies, identify potential issues, and devise contingency plans
  • Selection and management of External Service Providers (ESP)
  • Responsible for the finalization of selected ESP contract, budget negotiation for assigned studies, and for the accurate and timely processing of ESP invoices
  • Acts as a central point of contact, lead, and manage the communication between the study team and all stakeholders to support the implementation of assigned studies
  • Make clinical supplies projections in collaboration with Pharmaceutical Development-Clinical Trial Supply
  • Responsible for the timely operational input in the review and delivery of study-related documents
  • Lead the collection, review, and finalization of documents required for Independent Ethics Committee (IEC)/Institutional Review Board (IRB) and Health Authorities submissions
  • Responsible for ensuring that all essential documents required for Investigational Medicinal Product (IMPs) shipment of assigned studies are in place prior to shipment
  • Provide direction and support to monitoring activities of assigned studies by authoring the Study-Specific Monitoring Plan and coordinate/participate in the monitoring as needed
  • Responsible for inspection readiness, completeness, and quality of assigned studies' TMF from study start to archiving
  • Follow relevant quality control procedures to ensure the quality requirements for the study-related activities are fulfilled
  • Provide guidance and mentoring to less experienced colleagues within the team

Qualifications and Experience:

  • Post-graduate degree in life sciences degree or equivalent
  • Minimum 4 years early phase project management experience 
  • Knowledge of practical applications of ICH-GCP, and of regulatory guidelines/directives for the conduct of clinical studies required
  • Good organizational and problem-solving skills with the ability to work in a matrix environment
  • Demonstrated ability to work in teams in a fast-paced environment, to prioritize multiple competing tasks, and to proactively address issues and demands
  • Proven record of successfully interacting with different stakeholders, implementing solutions and negotiating contracts
  • Ability to communicate effectively with internal and external stakeholders in fluent written and spoken English
  • Relevant working/residency permit or Swiss/EU-Citizenship required

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