Reference: 306 07/06/2022 00:54:51

Project Manager.

United States - United States Competitive

The Project Manager will be working as part of the Global Project Management Office (gPMO) and proactively manage the project level operational aspects of the Clinical Trial Team (CTT), including management of trial timelines, budget, resources and vendors.

This position can be based regionally within the continental US (Remote).

Essential Functions

  • Drive the planning and conduct of assigned Phase I/IIa studies and associated operational activities by overseeing all deliverables, milestones, data quality, and deadlines related to the assigned clinical studies
  • Provide efficient updates on trial progress to the Global Project Management Director (gPMO) with respect to vendor selection, project plans, trial budget and timeline management, quality standards and risk mitigation.
  • Lead study startup process, including but not limited to conduct of the Trial Kick-off meeting, the set-up of trial master file (TMF), site selection and finalization of site and vendor Clinical Trial Agreements and budgets.
  • Ensure effective project plans are in place and operational for each trial and work proactively with the Clinical Trial Team (CTT) to set priorities in accordance with applicable project plans, company standard operational procedures (SOPs), ICH/GCP guidelines and regulatory requirements.
  • Ensure potential study risks are escalated to the attention of the gPMO when appropriate.
  • Lead Project team meetings and ensure meeting minutes are completed, distributed to team members and filed in the Trial Master File (TMF) in a timely manner. Review and approve site visit reports; ensure tracking, follow up and resolution of site issues have been completed in a timely manner.
  • Monitor the quality of vendor deliverables, address quality issues with the appropriate team member and identify opportunities to improve training, execution and quality control across the clinical team
  • Review and approve vendor responses to quality assurance audits for appropriateness, timeliness and accordance with company SOPs and regulatory requirements.
  • Ensure all project level study documentation is filed in the TMF in accordance with company SOPs/all regulatory requirements and provide oversight to the clinical team regarding TMF filing, maintenance and archival procedures
  • Effectively provide support to Clinical Site Manager(s) in the conduct of the trials
  • Track clinical and non-clinical budget(s) to assure spending levels of each function is consistent with commitments
  • Review and approve vendor invoices in collaboration with the Accounting team to ensure payments occur in a timely manner
  • Develop and maintain both high level and detailed timelines with input from the functional departments, and ensure that the functional timelines are aligned with global project timelines
  • Bring potential timeline issues to project leader attention for resolution, and participate in resolution
  • Partner with Global Project Management Office to implement best practices across project teams e.g., resource capacity planning, project risk management, team performance, timeline development, portfolio management

 

Knowledge / Skills / Abilities

  • Bachelor’s Degree in clinical or pharmaceutical sciences, nursing, or related scientific discipline.
  • Experience in early phase trials (Phase I-II) and First-In-Man trials (preferred)
  • Demonstrated expertise in project management
  • Excellent organizational skills
  • Possesses a global understanding of the drug development process, (more or less extensive depending on level and scope of project assigned) including clinical site operations, and a cross-cultural awareness
  • Understanding of financial planning expenditures, and project budgeting process
  • Demonstrated ability to work well with others within and across functions/teams
  • Cross-functional coaching skills
  • Ability to hold oneself and others accountable for commitments in a productive and assertive, positive (not aggressive) manner
  • Good analytical and planning skills
  • Strong communication skills both written and verbal
  • Possesses good conflict resolution skills
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Consultant.

Joe Bell
Joe Bell
Delivery Consultant View Profile

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