Project Manager (Early Phase)

Reference Number: 895629-W
Type of placement: Contract, Contract, 12 months
Location: Switzerland, North West

Introduction:

For one of our clients, we are currently looking for a Project Manager (Early Phase).

Main Responsibilities:

  • Drive the planning and conduct of assigned Phase I/IIa studies and associated operational activities by overseeing all deliverables, milestones, data quality, and deadlines related to the assigned clinical studies
  • Perform qualification visit (when required) and initiation visit as agreed with the Clinical Pharmacologist for the assigned studies
  • Perform routine monitoring visits and close-out visits at the frequency determined for the assigned studies assuring that the CROs are delivering high quality research
  • Responsible for the accurate and timely completion of e-Procurement tasks related to contracts of assigned studies and for ensuring invoice payments are made in timely manner
  • Responsible for the supervision of CROs from study start up to Trial Master File (TMF) archiving
  • Manage and supervise the interaction of appropriate department and cross-functional team members to support the assigned studies from study start to TMF archiving
  • Make clinical supplies projections in collaboration with Clinical Trial Supply in Technical  operations
  • Contribute to the review of study-related documents including, but not limited, to protocol outline, protocol and protocol amendment, Informed Consent, Defined Task of the Delegation of Authority Form, Case Report Form, Monitoring Guidelines, Study Forms, Clinical Study Report
  • Coordinate the preparation of submission documents to IRB/IEC and Health Authorities
  • Manage the submission of essential documents required for the IMP shipment approval
  • Prepare and deliver status report for assigned studies as required
  • Provide direction and support to the management of the monitoring of assigned studies and coordinate/participate in the monitoring as needed
  • Manage Trial Master File maintenance and oversee the quality control review of the Trial Master File prior to archiving
  • Ensure completion of Clinical Trial Management System when applicable
  • Share and promote best practices across Clinical Pharmacology
  • Follow relevant quality control procedures to verify that the quality requirements for the trial-related activities are fulfilled
  • Provide Operational expertise and overall efficient day-to-day management of the clinical studies
  • Ensure adequate sponsor oversight of the clinical studies
  • Develop and maintain effective working relationships with study team members
  • Contribute to the development and management of the study timelines, risk and quality plans
  • Lead the development of the Monitoring Plan and any operational plans 

Qualifications and Experience:

  • Preferably university degree in either a biological science or healthcare profession
  • 2- 5 years clinical study management experience in CRO and/or Pharmaceutical/Biotechnology
  • Industry environment
  • Proficient knowledge of ICH-GCP, and of regulatory guidelines/directives for the conduct of a clinical development program
  • Excellent project management skills: can prioritize multiple tasks and goals
  • Strong teamwork orientation
  • Excellent interpersonal skills.
  • Detail-oriented and well-organized
  • Fluent in both written and spoken English
  • Relevant working/residency permit or Swiss/EU-Citizenship required

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