Job Description

BASIC QUALIFICATIONS:

• Degree in relevant field with life sciences or medically related experience work
• Experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources.

PREFERRED QUALIFICATIONS:

• Experience in life sciences or medically related field, including biopharmaceutical clinical research experience obtained working on clinical trials at a biotech, pharmaceutical or CRO company
• Previous management experience with direct reports
• Experience at or oversight of outside clinical research vendors (CRO’s, central labs, imaging vendors, etc.)

WHAT YOU WILL DO

In this vital role you will be part of Clinical Program Operations (CPO) to plan and executes the operational aspects of clinical trials globally.
Reporting to the Clinical Program Management Associate Director (CPM AD) will be the Global Clinical Trial Manager (GCTM).
Reports to: Clinical Program Management Director

RESPONSIBILITIES:

• Supports the CPM-D in coordinating and overseeing the operational strategy, planning, risk assessment and mitigation, and overall execution of clinical trial programs globally (accountable for all studies in the program if no director level present)
• Line Management of GCTMs
• Ensures high-quality execution of clinical trials on time and within budget
• Supports / Leads the Global Clinical Study Team for the allocated program(s)
• Provides clinical operations leadership and expertise on the Evidence Generation Team (EGT) and in development of the Evidence Generation Plan (EGP) and provides clinical operations leadership and expertise in EGP execution through the feasibility and study design process
• Maintains global business relationships cross-functionally and communicating global status of clinical trial programs to senior management and oversight of study/ team issue escalation
• Initiates and supports conduct of Country Operational Landscape Assessments and study feasibility with Development Feasibility Senior Managers
• Supports / Accountable for study global enrolment plans revised enrolment plans and accurate global recruitment forecasting
• Reviews vendor evaluation to include identification of outsourcing requirements for study / program and oversee management of vendors
• Supports and oversees internal audit and inspection activities and contributes to CAPAs globally for the program
• Supports CPO resource planning for assigned program(s) in collaboration with Program Resource Management (PRM) and CPM-D
• Support continuous improvement initiatives in Clinical Program Operations and Global Development Operations (GDO)