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Clinical Project Manager

  • Locatie:

    Brussel, België

  • Contactpersoon:

    Charlotte Evens

  • Contractsoorten:

    Contract

  • Telefoon contactpersoon:

    +32 15 28 40 43

  • Bedrijfssectoren:

    Life Sciences, Clinical Research

  • E-mail contactpersoon:

    charlotte_evens@oxfordcorp.com

Do you have clinical project management experience and are you looking for an international, remote based function? Don't hesitate and apply today !

Job Description

The Senior Project Manager (PM) is responsible for the overall coordination and management of clinical trials from start up through to final delivery. This position directs the technical and operational aspects of clinical projects - all with the sense of urgency expected of customers. You must have oncology experience; preference for early phase oncology, along with immune-oncology and/or cell therapy.

Responsibilities

  • The Senior Project Manager leads the project team, ensuring the project is delivered according to planned scope and timelines in accordance with the contract
  • The Senior Project Manager creates and executes project management plans required for project delivery and in accordance with established processes
  • The Senior Project Manager ensures quality and adherence to the relevant policies, SOPs, and working instructions, GCP and regulatory guidelines
  • The Senior Project Manager establishes clear communication lines and escalation pathways, communicates with project stakeholders
  • The Senior Project Manager provides input on study related documents such as the study protocol, CRF, Medical Review/Monitoring plan, and Clinical Study Report
  • The Senior Project Manager establishes requirements for and ensures project specific training plan for team activities
  • The Senior Project Manager leads internal and external meetings, with internal and sponsor teams, including Kick Off Meetings (KOM) and Investigator Meetings based on project scope
  • The Senior Project Manager provides support for vendor identification, qualification and selection and manage vendors
  • The Senior Project Manager manages vendors and vendor relationships as required for project delivery
  • The Senior Project Manager ensures effective and efficient resource utilization across projects and programs
  • The Senior Project Manager produces, maintains and circulates project progress and status reports
  • The Senior Project Manager manages the study budget, including monthly invoicing.
  • The Senior Project Manager establishes project risk management plan with input from client and functional stakeholders and oversees adherence and updates throughout the project lifecycle
  • The Senior Project Manager proactively recognizes and addresses any changes in scope
  • The Senior Project Manager negotiates and influences internal and external team members in a professional manner and with successful outcomes
  • The Senior Project Manager effectively solves problems with projects teams by applying strategic thinking and conflict resolution skills
  • The Senior Project Manager conducts review of initiation, monitoring and close-out visit reports
  • The Senior Project Manager may perform co-monitoring visits
  • The Senior Project Manager ensures the Trial Master File is kept up to date and inspection ready
  • The Senior Project Manager serves as the primary point of communication between the sponsor and project team
  • The Senior Project Manager leads by example and encourages team members to develop strong solutions for clinical trial delivery
  • The Senior Project Manager is responsible for oversight of project team delivery and communication with functional managers, including performance feedback
  • The Senior Project Manager may be assigned as line manager


Requirements

  • You hold minimum a Bachelor's degree in life science, healthcare and/or business degree
  • Minimum 5 years of experience in drug development and/or clinical research, with at least 3 years of clinical trial project management experience
  • Preference for candidates with CRA experience
  • You have good knowledge of ICH-GCP(R2), data and patient privacy practices, and applicable (local) regulatory requirements
  • You demonstrate strong financial acumen, administrative excellence and analytical skills
  • You have experience in managing all phases of the full-service clinical trial delivery lifecycle (Start-up, Maintenance, Close-out)
  • You have excellent written and verbal communication, planning, critical thinking and organizational skills, including command of English language
  • You are representative, outgoing and client focused
  • You have the ability to work effectively in a fast-paced challenging environment with a growing company
  • Proficiency with various applications including, but not limited to, Microsoft Word, Excel, and PowerPoint required
  • You have strong presentation skills
  • You foster learning and the advancement and development of others
  • You are dependable and able to take action to quickly to address urgent needs
  • You are proactive and solution oriented
  • You willingly take ownership and drive positive, collaborative results with the project team
  • You exercise good judgement with defined procedures and policies to determine appropriate action
  • You have the existing right to work in Europe


Benefits

  • A balanced salary package based on your capabilities and experience, including extra legal benefits (ADV days, company car, fuel card, insurances, ...)
  • Opportunity where they are open for freelancers as well
  • Full-time position (80% negotiable)

Vacancy number: 18551

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