Senior Clinical Operations Manager

5 giorni fa

Milan, Italia Culture Digitali Srl A tempo pieno
Senior Clinical Operations Manager

PARK Senior Villas Chandler seeks a highly skilled Senior Clinical Operations Manager to lead our clinical operations team. As a key member of our organization, you will be responsible for coordinating the functional team members and their activities across all geographies, liaising with project leadership and the sponsor to ensure that the Clinical Operations deliverables (timeline, quality, productivity) are met.

Key Responsibilities:

  1. Client Liaison
  2. Effectively communicate with internal and external customers as well as third party vendors
  3. Prioritize effectively and respond to urgent requests within team or from sponsor
  4. Manage study start-up activities
  5. Provide input to project tools, PL project plan, Central File Maintenance Plan
  6. Provide input to the format and content for sponsor reports
  7. Provide input to and oversight of site selection strategy plan
  8. Develop site selection and monitoring plans for the team
  9. Review and provide input into patient recruitment plan and retention plan
  10. Establish efficient / effective working relationships with other functional Leaders and coordinators across geographies within a given program
  11. Develop study plans, tools and forms
  12. Provide leadership and direction to project team members
  13. Evaluate and identify resourcing needs and continuously monitor the use of resources over project life cycle of project
  14. Provide productivity targets to project team members
  15. Early recognize areas of potential problems and provide input to contingency plans
  16. Monitor study timelines, patient recruitment, retention and data cleaning to ensure successful outcome of the project
  17. Maintain and assure quality of work generated and escalate and follow up as appropriate
  18. Implement and instigate process improvements within the project
  19. Provide input to the Revenue Recognition forecast
  20. Identify changes in scope and liaise with Project Leader
  21. May be required to conduct site visits as per client or project demands
  22. Participate in client, investigator and team meetings
  23. Prepare, participate in and follow up on audits / inspections
  24. Collaborate with project team (e.g. Project Leader and Data Operations Leader) on database lock activities
  25. Together with Project Leader ensure all administrative closeout procedures are completed, according to Project Close-out Checklist
  26. Together with Project Leader ensure project is archived and all documentation returned to the client as specified by the contract
  27. Participate in end of study meeting and give input to lessons learned information and feedback relevant information into the relevant functions
  28. Maintain a working knowledge and ensure compliance with applicable ICH-GCP Guidelines, local regulatory requirements and Parexel WSOPs, SOPs, Operational Guidelines, Work Instructions and study specific procedure
  29. Complete routine administrative tasks in a timely manner (e.g. timesheets, metrics, office and travel expense claims)

Qualifications:

  1. Substantial experience in clinical research including relevant experience as a Team Leader in Clinical functions or proven experience in coordinating clinical trials
  2. Experience in Phase I Oncology experience advantageous
  3. Degree in a life science, nursing qualification or relevant experience
  4. Competent in written and oral English
  5. Strong understanding of the cross functional activities
  6. Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail
  7. Effective time management in order to meet daily metrics or team objectives
  8. Personal skills that include: ability to take initiative and work independently, ability to successfully work in a team environment, sense of urgency in completing assigned tasks
  9. Excellent interpersonal, oral and written communication skills
  10. Excellent presentation skills
  11. Ability to travel as required
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