This role is responsible for the development and management of a portfolio of projects and/or programs, with respect to the delivery of quality project management services.
Responsibilities:
Monitor the status and make changes as needed to meet the deliverables of the trial.
Assess, identify and monitor trial-level risks. Incorporate scientific knowledge, trial process, and expertise to create one integrated trial-level risk mitigation and contingency plan.
Identify and facilitate resolution of complex study problems and issues proactively.
Create and monitor the overall budget andassumptions using financial tracking tools.
Manage CRO qualification process, selection,and oversight to ensure that all clinical trials’ execution with SOP and local laws and regulations.
Support with cross-functional team to facilitate the trial protocol development and maintenance process.
Collaborate with supply chain team to develop and complete of the request and management for clinical supplies.
Organize regular study team meetings on an agenda driven basis, and report study progress/update to the management team when required.
Develop and track trial enrollment plan by gaining alignment and integrating inputs across functions and geographies. Be accountable for trial enrollment strategy and execution with clinical operations to achieve enrollment goals.
Work with the internal quality control and site to ensure high quality of trial.
Plan and lead activities associated with audits and regulatory inspections.
Provide input to process development and improvement.
Requirements:
Minimum 10 years’ experience in Clinical Operations or other related fields with minimum 5 years’ project management experience
Clinical research background, with medical and scientific knowledge preferred
Excellent knowledge of spoken and written English
Working knowledge of MS Office suite and MS Project or equivalent
Strong communication and presentation skills
Traits:
1. Solid problem solving and time management skills
