Are you in need for an experienced senior clinical research professional to coordinate and manage activities of your clinical trial(s)? Project management services are either offered as full service support for all trial related tasks from start up through close out or for specific tasks and trial phases if only temporary support is needed to absorb work peaks.

Clinical project management services include:

• Trial management of phase II-IV trails, NIS and Managed Access Programs (e.g. NPP, CUP,
  donation program, etc.)

• Ensure that all project deliverables meet the client’s time/quality/cost expectations
• Lead cross-functional trial teams through start-up activities to study conduct, analysis
  and reporting

• Budget management to meet defined financial performance targets
• Manage project resource needs and establish contingency plans for key resources
• Establish excellent working relationships with project teams and vendors to ensure client
  satisfaction and operational excellence

• Ensure project deliverables are met according to client expectations
• Develop and lead the presentation on trial status to governance bodies and other relevant
  committees for deviations from budget and timelines as needed, highlighting issues and risks

• Initiate improvements to enhance the efficiency and the quality of the work performed on
  assigned projects

• Selection, collaboration and management of external vendors
• Ensure successful design, implementation, tracking and revision of trial documents such as
    o Clinical trial protocol
    o Case report forms
    o Informed consent
    o Project plans and manuals
    o Clinical trial reports
    o Newsletters
    o etc.
• Ensure adherence to ICH/GCP-guidelines, local law and regulations
• Ensure that all staff allocated to assigned projects adheres to professional standards and
  SOPs established for clinical research

• Ensure inspection readiness and provision of support during an audit
• Preparation of regulatory submissions to IRB/IEC and CA
• Review and maintenance of trial master file and country files
• Plan, attend and present at Investigator Meetings
• Support cross functional teams during bid defense meetings

Lead CRA related services include

• Lead CRA-team and conduct co-monitoring visits
• CRA-training
• Review of monitoring reports
• Design, review and implementation of Monitoring tools

Countries covered

Services are provided globally