Job Summary

The Project Manager leads the Xcene and Sponsor teams by combining a depth of clinical research experience and project management skills with insight into sponsor pressures and an ability to develop the right solution for each sponsor.

  • Minimum Qualification: MBBS
  • Experience Level: Senior level
  • Experience Length: 4 years

Job Description/Requirements

  • Achieves study objectives by working with team members to set project priorities and milestones and resolve project conflicts.
  • Owns the sponsor relationship and is responsible for sponsor communication.
  • Optimizes processes for projections including cost, enrollment and Investigational Product forecasting.
  • Implements standardized project plans and planning processes.
  • Implements an efficient contracting and vendor selection process.
  • Establishes efficient vendor management processes.
  • Establishes standardized metrics and optimal reporting formats.
  • Develops and maintains SOPs and work practices applicable to a global organization.
  • Periodically reviews processes across clinical trial projects to ensure compliance and consistency.
  • Participates in, or leads, infrastructure development project teams to enhance department growth.
  • Lead strategic level work (e.g. partnership collaboration meetings, etc.)
  • Provides a central point of study contact and single point of escalation on behalf of the functional teams (clinical, data management, biostatistics, medical writing, logistics, contracts, finance, medical and pharmacovigilance).
  • Proactively communicates with the sponsor and internal groups ensuring that they have all the information required on project progress and status (risk analyses, what-if scenarios, contingency plans, technical information, significant changes of any kind, etc.).
  • Provide proactive decisions /solutions and how the project objectives are being or should be, achieved.
  • Prioritize effectively and respond to urgent requests within the team or from the sponsor.
  • Maintain a positive, results-orientated work environment, building partnerships and model teamwork, communicating to the team in an open, balanced, and objective manner.
  • Lead team meetings on a regular basis with the project team.
  • Lead regular meetings/calls with sponsors to ensure they are fully informed of project progress, proactive decisions/solutions and how the project objectives are being achieved.
  • Communicate fiscal, contractual, resource, deliverable and sponsor-related issues to management as appropriate.
  • Accountable for sponsor satisfaction as measured by client survey responses and repeat business.
  • Support with pre-award activities, including presentations and meetings.
  • Manage study start-up activities.
  • Initiate the project following a review of Lessons Learned to ensure current Best Practices are implemented.
  • Define, plan and provide oversight of site selection strategy.
  • Review the applicable project contract/exhibit and provide comments as appropriate.
  • Lead the project such that it is completed within budget, schedule and according to contract specifications.
  • Ensure the project is progressing according to quality standards, SOPs, ICH-GCP and/or other guidelines to fulfil local regulations.
  • Ensure information entered relevant Xcene management systems is accurate and updated on a regular basis.
  • Oversee maintenance and quality check of regulatory files/investigator site files.
  • Address identified and escalated project issues and drive to closure.
  • Coordinate monitors and vendors according to the monitoring plan/contractual obligations (as applicable).
  • When required, review monitoring visit reports and ensure issues are resolved in a timely way.
  • Review monitoring feedback and ensure issues from on-site monitors are resolved in a timely way.
  • Monitor study timelines, patient/subject recruitment, retention and data cleaning to ensure a successful outcome of the project.
  • Prepare, participate in and follow up on audits/inspections.
  • Identify and manage/communicate CIS (changes in scope) in a timely manner if applicable.
  • Manage the project budget including providing input into revenue recognition, milestone payments and monthly pass-through invoices.
  • Oversee all administrative closeout procedures are completed, including IRB termination, final milestone payments are billed, etc.
  • Ensure the project is archived and all documentation returned to the sponsor as specified by the contract.
  • The lead end of study meeting to ensure lessons learned information is documented and passed on via appropriate channels.

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