Clinical Project Management

Clinical Project Management

Your single point of access to an expert team

A highly skilled Clinical Project Manager (CPM) is a pre-requisite for a successful clinical study. Our CPMs are extensively trained and competent, with experience in managing cross-functional teams executing international Phase I-IV studies as well as medical device/IVD studies from initiation to completion.

The CPM will act as main point of contact internally and externally. They will always work to make sure that deliverables are completed with high quality, on budget and time as well as to the customer’s satisfaction.

Our CPMs can also be outsourced for your specific needs.

Our strategic partnership

As part of our strategic partnership, we will carefully assign a CPM perfectly suited to helping you overcome your challenges. They will liaise with experts in market access, medical writing, data management, regulatory affairs, and pharmacovigilance as needed.

LINK Medical has around 10 CPMs that works internationally in studies performed in Europe and beyond. The Clinical Project Management team has  a long track record of reliable support (i.e., 113 years cumulative clinical experience) for a  diverse range of projects regardless of their size, therapeutic area, or complexity.


Project Management Services

  • Internal, vendor and sponsor communication and oversight
  • Negotiation and finalising contracts with vendors (MSA, WO and DPA)
  • Responsibility for the budget including managing out of scope
  • Proactive Risk Management as a key activity
  • Oversight of Risk-Based Monitoring activities
  • Issue escalation processes are implemented at all stages and enables us to confidently solve any issue that may arise throughout the study, including governance support
  • Close collaboration with our QA department, ensuring your clinical studies pass audits and inspections
  • Development of project plans and timelines – an integral part of good project management within LINK Medical
  • TMF oversight ensuring inspection readiness at all times
  • IMP supply management
  • Managing Protocol Deviations throughout the study
  • Oversight of study team training and hand-over
  • Management of back-end services including clean file and up until clinical study/ investigational report
  • Develop charter and organise Safety Review Committee Meetings when applicable

Clinical Trial Administrator

The Clinical Project Management department also includes our Clinical Trials Administrators (CTAs). The CTAs are responsible for administrative tasks as handling and filing of study documents in the Trial Master File (TMF) including QC. Our CTAs are expert users on the Viedoc eTMF that is used in most of our studies. A CTA is allocated in each study to support the CPM and project team with administrative tasks and plays an important role in helping ensure the study runs smoothly and that the TMF is inspection-ready at all times.

Our CTAs can also be outsourced for your specific needs.

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