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Study Manager

Brice Group

21 sep

Study Manager

Consultant period: 12 months with possible extension or transfer into employment with our client.

Work: Part time (to be discussed)

The Clinical Study Manager has responsibilities for planning and performing clinical studies and associated operational activities by overseeing CRO. This includes deliverables, milestones, data quality, and deadlines related to the assigned clinical studies.

You will work in close collaboration with a senior Clinical Trial Director and report to CEO or Medical Director

  • The Study Manager is responsible for management of clinical study activities within clinical development. You will ensure that clinical trials are executed in accordance with written procedures, applicable guidelines and regulations.
  • Involved in the day-to-day oversight of CRO and other vendors. You will be responsible for the management of the interfaces between all vendors/consultants related to the clinical trials.
  • Maintenance of TMF located at sponsor during the conduct of the study and for final archiving of the combined, final TMF.
  • Responsible for logistics, i.e., shipment of equipment provided by vendors.
  • Conduct co-monitoring as needed.
  • Responsible for the development and sponsor oversight of clinical trial subject recruitment strategies.
  • Make clinical supplies projections together with the CMC Director.
  • Prepare and deliver status reports for assigned studies to management.
  • Participate in the development of trial-related core documents, such as the protocol, Investigator Brochure, study report etc.
  • Involved in organisation of Investigator meetings.
  • Review study documents as drafted by CROs and ensures operational input from team members.
  • Track and manage agreed study timelines, budget and resources.
  • Must be aware of and be trained on the quality regulations, procedures, guidelines and company standards applicable to the area of responsibility.

COMPETENCE REQUIREMENT AND ABILITIES

  • Experience as CRA or Study Manager
  • Experience from Managing CROs or working in a CRO

PROFILE

  • Willing to roll up your sleeves and take initiative
  • Enjoy working in a smaller organization
  • Excellent Project Management skills
  • Willingness to learn
  • Team player

WHAT THE COMPANY OFFER

The Company has just completed a very succesful funding round and has received great reviews on the project from both investors and researchers. Thus you are entering a highly intensive and exciting phase.

You will join a highly experienced team with solid knowledge, generous atmosphere.

The team members are open to initiative and support and set the team and shared objectives at the top of their agenda.

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