Telephone 0203 778 0909 | Email office@al2s3.com

Project Manager, Clinical Pharmacology (Contract)

  • Location:
  • Salary:
    negotiable / Up to 120 CHF P/Hour
  • Job type:
    Contract
  • Posted:
    3 weeks ago
  • Category:
    Clinical
  • Deadline:
    January 29, 2020
  • Languages:
    English

 

Project Manager, Clinical Pharmacology (Contract)

AL Solutions are searching for an experienced Contract Project Manager to work within Clinical Pharmacology on an initial 12 month contract with a top pharmaceutical company based in Basel, Switzerland.

You will be working for an industry leader with a reputation that is recognised and valued by all of the market leaders and their competitors.  A contract with this company looks great on your CV, helps you to develop many new skills, and most certainly does well for your bank balance!

 

Job 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

 

 

Candidate’s Requirements

  • Post-graduate degree in life sciences degree or equivalent
  • Early phase project management experience is desirable
  • Knowledge of practical applications of ICH-GCP, and of regulatory documents for the conduct of clinical studies
  • Agreement and Budget negotiation experience/awareness is also desirable
  • 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

 

Apply

AL Solutions are a niche Life Science recruitment consultancy. We place professionals across the UK/EU for a variety of biotechnology, pharmaceutical and CRO companies ranging from small start-ups to large global organisations.

 

If you’re interested, please apply below. If this position doesn’t interest you, please visit our website for a list of more vacancies – www.al2s3.com or reach out to us via:

 

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