Back to jobsDefine (for early development), or work with the Director to align on, the Operational Strategy for each trial in the program and gain governance endorsement on proposed plans
Lead operational scenario planning and mitigate trial level risks that may impact timelines / budget.
Ensure appropriate timely and quality oversight, and appropriately escalate issues to the Director, Quality and functional leadership.
Ability to effectively communicate the operational strategy, and defend the operational plan and costs associated to CTWG, CDST, Director, leadership and at governance meetings as appropriate.
Lead and ensure inspection readiness for the trial/s
Build knowledgeable and skilled team with competencies and capabilities to successfully set up and deliver clinical trials
Promote strong collaboration across cross-functional teams
Setting goals in alignment with company, program, and departmental goals
Ensure staff training on procedures and systems associated with their roles
Develop a team that consistently achieves strong results through nurturing individual growth, effectively managing performance, and providing guidance
For early development programs, AD may represent Clinical Operations at CDST
Interface with internal key stakeholders including, but not limited to; Finance, Program Management, Vendor Management, Safety, Accounting, Supply, Quality Assurance, Data Management, Statistics, Clinical Research, Commercial, Regulatory, Bio Analytical, Medical Affairs; which may include acting as a liaison between groups.
Lead or participate in process improvement activities at a trial and department level as needed
Participate in preparation for, and conduct of, Health Authority Inspections and internal QA audits
Ability to travel (expected annual average of 10% but flexibility to go over or below this as required).
