Senior Clinical Project Manager

Discipline: Clinical Research
Job type: Permanent
Salary: £Salary: On application
Contact name: Roxanna Keshavarz

Contact email: Roxanna.Keshavarz@rbwconsulting.com
Contact phone: 1293584300
Job ref: 21911
Published: about 1 month ago
Expiry date: 30 July 2021

I’m partnered with a global CRO who is looking for a Senior Clinical Project Manager based in the Netherlands.

The Senior CPM will act as a matrix leader for the global clinical operations team under the supervision of the Clinical Operations Manager and will be accountable for the timely execution of specific tasks within the protocols.

Responsibilities:

  • Conduct feasibility, pre-study visits, site initiation visits, monitoring visits and/or close out visits as necessary

  • Ensure that the monitoring team is trained on study specific procedures and aspects

  • Coordinate and oversee project activities

  • Update and check the Trial Master File (TMF) of the studies within Switzerland as well as ensuring that the site TMF are checked by the monitoring team according to CRO and Sponsor procedures

  • Coordinate and oversee project activities

  • Organise project activities and evaluate timeframes

  • Manage the vendors involved in the study

  • Review and approve the Investigator’s Folder and Trial Master File prototype

  • Verify compliance with operating procedures

  • Ensure that the monitoring activities are conducted as per monitoring plan requirements

  • Review monitoring, remote monitoring, contact and telephone contact reports

  • Send regular updates to the Sponsor

  • Collaborate in establishing and maintaining SOPs related to Clinical Operations Unit

Moreover, the Senior Clinical Project Manager can conduct Feasibility, Pre-study Visit, Site Initiation Visit, Monitoring Visit or Close out visit as necessary (e.g., back-up or directly allocated to the site) if the CPM is compliant with local minimum requirements for monitoring.

Requirements:

  • Degree in a scientific field

  • In depth knowledge of GCP and techniques for the monitoring of clinical trials

  • At least 5 years working as a Clinical Project Manager

  • Fluent in English and Dutch

  • Able to coordinate all the activities related to the management of local and international projects including managing interventional clinical trials, monitoring of clinical trials, and guaranteeing the security of information; preferably in CRO environment

  • Work independently under the supervision of the Head of Clinical Operations Unit and Clinical Operations Manager

  • Ability to interact with personnel properly and to manage the monitoring activities of CRAs (if required)

If you are interested in discussing this role in further detail, please don’t hesitate to apply or reach out to me: Roxanna.keshavarz@rbwconsulting.com / +44 1273 952187.

Salary: On application