Clinical Project Coordinator

3 weeks ago

San Diego, United States Redbock - an NES Fircroft company Full time

A fast-growing biotechnology company in San Diego is in immediate need of a Clinical Project Coordinator Consultant for a 6-9 month project. The client is focused on developing innovative cancer therapies. This consultant will be reporting into the Program Management team and coordinating closely with the Clinical teams. There are 6 Project Managers on the team in various roles and the company has ~200 employees. This is a hybrid, onsite position.


Working closely with Clinical Operations, Biometrics, Regulatory, Drug Supply, and other members of the Clinical Trial Team (CTT), the consultant will compile cross-functional timelines and Gantt visualizations to keep the project on track and aligned on key milestones. The position requires an in-depth knowledge of the study management process, particularly in consideration of risks to the study plan that can be foreseen and mitigated. The Clinical Planner Consultant is a new role with the client company, the specialist is needed to support ~10 major milestones with critical deadlines. The consultant needs to be skilled in the use of MS Project for clinical study management and vendor management. The consultant will need to be proactive and self-sufficient to drive studies forward and coordinate with cross-functional teams.


Duties:

  • Create and maintain cross-functional clinical trial timelines in MS Project for each assigned study, including the key tasks, milestones, and dependencies that drive successful delivery of the clinical database and study report.
  • Tracking progress against the plan, comparing study progress to project team and corporate goals, and flagging variances in a timely manner.
  • Generate reports in OnePager to support the CTT’s ability to visualize the critical path and identify operational risks to the study plan.
  • As needed, produce scenarios to enable the team to support decision making.
  • Communicate study roadmaps to the CTT during team meetings, identifying upcoming deliverables and risks that the team should consider.
  • Work with the head of the PMO to create standards and templates that can be used to establish efficiencies in the Program Management department.
  • Work with Program Managers to transfer information from the clinical trial level to the asset development level.


Top Requirements:

  • BS degree minimum
  • 5 years of drug development experience
  • 2-3 years of study management experience
  • Strong knowledge of vendor management process
  • Strong expertise in planning and coordination of clinical studies
  • Experience working with Oncology therapy companies is highly preferred
  • Strong expertise using MS Project to plan projects for Clinical studies

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