SENIOR PROJECT MANAGER

We are currently seeking 2 Senior Project Managers to join our Clinical Operations Team based in Hoogeven, Netherlands & Rheinbach, Germany.  The role holders will be responsible for both the operational and financial performance of the assigned project(s). This role will coordinate and manage the activities of the studies, costs and project team to agreed timelines adhering to SOPs, GCP and all appropriate legislation and guidelines.

Responsibilities & Accountabilities:

• Lead the project team
• Ensure delivery of services per the agreed scope of work (or the current Change in Scope)
• Identify and manage deviations from the agreed scope of work
• Manage and drive the Changes in Scope process
• Delivery of projects tasks, including but not limited to:
  
  • Supervision / Preparation of Ethics Committee / Competent Authorities Submissions and follow-up
  • Development of project specific conventions (PSCs)
  • Development of project quality metrics
  • Review of critical documents packages
  • Tracking of all project relevant study material distribution
  • Adequate training of all staff allocated to the project
• Vendor oversight and contract management
• Prepare / review study progress reports
• Prepare / update Project Management Plan (PMP)
• Supervise set-up and maintenance of all study related management tools
• Prepare / supervise project team meetings
• Manage project budget and perform monthly reconciliation of finance / project reports, assessing and reporting on status of budget
• Provide project updates to the sponsor, project team and senior management
• Contribute to business development activity, including participation in client meetings
• Take responsibility as mentor and trainer for PMs/CRAs/CTAs required by the business
• Prepare and review feasibility reports
• Review pre-study visit reports, site initiation visit reports, site monitoring visit reports and site close-out visit reports
• Ensure that investigator payments / payments to third parties are processed in a timely manner and are properly tracked
• Contribute to the continuous improvement of the clinical operations department
• Acts as the primary project related representative of the company

Key Capabilities Required:

Qualifications & Experience:

• Master’s or Bachelor’s (or comparable) level degree in life sciences, pharmacy, nursing or other relevant disciplines
• Proven track record of successful project delivery as Project Manager either with Venn or a previous employer
• Minimum of 5 years’ experience in clinical trials
• Minimum of 2 years’ project management experience, preferably including a minimum of one year from within a CRO in PM role
• International project management experience (i.e. two or more countries involved)
• Vendor management experience

Skills:

• Team leader exhibiting exemplary work and management ethics
• Excellent interpersonal skills with the ability to work diligently, accurately and under pressure, alone and/or as part of a team
• Ability to establish and maintain effective working relationships with co-workers, managers and clients
• Excellent customer relationship management skills
• Ability to deal with complex, conflicting priorities and develop coherent, effective solutions
• Excellent written and verbal communication skills including fluency in English (additional language skills desirable)
• Excellent understanding and adherence to ICH/GCP regulations and Venn Quality Documents and processes
• In depth understanding of financial need and processes including revenue forecasting / recognition and invoicing practices
• Excellent computer skills including proficiency in use of Microsoft Office Tools

We offer an employment with excellent primary and secondary conditions. In our organisation, you can acquire a high level of responsibility and independency, broaden your knowledge, experience and expertise and work in close collaboration with our other development departments.