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Project Manager (Clinical Research and Development)

Markham
Job Order: GD-610

 

JOB SUMMARY:

  • This position is responsible for defining project scopes and estimating budgets, planning, directing, controlling project activities, managing resources and budgets, as well as project team performance of cross-functional teams engaged in clinical research and development activities. This position is also accountable for reporting of project progress status to company internal management and its clients. These activities include but are not limited to managing projects with activities focused on data management, statistics, medical writing, subject randomization and drug supply management (IWRS), administration of data monitoring and adjudication committees, as well as preparing drug submissions to regulatory agencies.
  • When required, the incumbent may assist the organization in responding to and preparing for Request for Information and Request for Proposals, and subsequently defining work scopes and budgets, and performing contract administration activities.
  • When required, the incumbent may perform clinical trial planning, management, and site monitoring from the initiation of a trial to its closure.

 

JOB ACCOUNTABILITIES:

  • Manage projects with activities focused on data management, statistics, medical writing, subject randomization and drug supply management (IWRS), administration of data monitoring and adjudication committees, as well as preparing drug submissions to regulatory agencies.
  • Integrate information to define work scopes and estimate budgets, develop and manage cross-functional project work plans including resource requirements and utilization, budgets, quality deliverables and timelines.
  • Manage all project management aspects of assigned Phase I -IV clinical trials and in accordance to ICH guidelines, FDA, Health Canada, EMA, and other applicable regulatory and legal requirements.
  • Lead cross-functional project teams. Manage the planning, implementation, conduct and reporting of assigned projects within the established timelines and budgets, and with the quality and requirements necessary for regulatory approvals.
  • Coordinate activities between the company and trial sponsors, and with various supporting groups or vendors when necessary.
  • Proactively track and manage the financial status against budget and reconcile expenses across sub-streams of activities.
  • Proactively track and manage project tasks against timelines and hours spent/budgets, alert management when there are risks of having major deviations.
  • Prepare project status reports and maintain accurate and current details. Present project status to internal and external stakeholders.
  • Function as meeting facilitator for the meetings involving various internal and external participants.
  • Function as facilitator of problem solving and conflict resolution.
  • Communicate project action items and key decisions through timely minutes and follow up actions.
  • Conduct “lessons learned” meetings with project team members to learn from failures and prevent same from future projects.
  • Contribute and/or participate in the performance evaluation of staff who performed under the responsible projects.
  • When required, the incumbent may assist the organization in responding to and preparing for Request for Information and Request for Proposals, and subsequently defining work scopes and budgets, and performing contract administration activities.
  • When required, perform clinical trial planning, management, and site monitoring from the initiation of a trial to its closure.

 

KEY EQUIPMENT/SOFTWARE USED:

  • Microsoft Word, PowerPoint, Excel, Project, Outlook, Calendar, Contacts, Tasks.
  • Knowledge of database systems, including Oracle, iDataFax, InForm, MediData Rave, and other Electronic Data Capture (EDC) systems.
  • Knowledge of CTMS (Clinical Trial Management System) systems.
  • Knowledge of SAS (Statistical Analysis System).
  • Other software as may be required.

 

QUALIFICATIONS:

  • B.Sc. or M.Sc. in life sciences or health related field.
  • 10+ years’ experience in clinical research and development within a pharmaceutical, biotechnology or CRO setting.
  • Demonstrated understanding of cross-functional processes including clinical operations, statistics, data management, subject randomization and drug supply management, data monitoring and adjudication committees, regulatory affairs, and medical writing.
  • Knowledge and understanding of ICH guidelines, FDA, Health Canada, and EMA regulations.
  • Ability to define scopes and estimate budgets, plan and manage projects, including resource requirements and utilization, hours spent vs. budgets, key deliverables and timelines.
  • Demonstrated leadership abilities, including setting goals for others and driving to achieve them in accordance with allocated resources, timelines, and budgets.
  • Excellent interpersonal, oral and written communication skills. Demonstrated strong negotiation and presentation skills.
  • Strong ability in problem-solving including conflict resolution.
  • Experienced as a clinical trial monitor, initiating, monitoring and closing out clinical trials will be desirable.
  • Fluency in French, including medical and scientific terminology, will be desirable.

 

DATE POSTED 2016-09-07

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