Global Trial Delivery Manager

We are seeking an experienced Global Trial Delivery Manager to lead the coordination of clinical trial management activities for internally managed and/or outsourced trials.

The successful candidate will lead the Study Management Team (SMT) and ensure global clinical operations deliverables progress according to agreed upon timelines and milestones.

Key Responsibilities:

• Lead the SMT, including providing updates to all trial team members on deliverable status
• Ensure availability of required reports to support real-time tracking of trial status according to trial plan
• Manage timely and accurate documentation and communication of trial progress
• Ensure that the SMT operates in a constant state of inspection-readiness
• Act as primary contact for Country and Regional staff
• Act as the primary contact person for the local teams within GCDO
• Partner with the Global Trial Lead to execute and oversee central activities from planning, trial start-up, through the life of trial to close-out
• Ensure issue escalation and drive issue resolution
• Work closely with Trial Team to ensure CAPAs are resolved timely
• Contribute to data collection to support the site selection process
• Participate in feasibility, providing recommendations as needed
• Establish enrollment commitments and ensure actual enrollment meets projected commitments across the regions at the clinical trial level
• Ensure the availability of robust recruitment/contingency plans are in place for each region
• Ensure timely tracking and filing in appropriate systems, as required at central trial oversight level
• Perform Annual Quality Review of files, as appropriate
• Ensure archiving and retention of documents per set requirements
• Establish country budgets and monitor actuals vs. forecast for Out-of-Pocket Expenses
• Oversight of selected vendors and status of related deliverables
• Review and approve assigned vendor invoices/spend
• Monitor budgets and expenditures as expected per planned trial budget
• Create and update trial-specific documents as required
• Provide input into cross-functional documents such as safety-related documents, protocol deviations and issue escalation processes
• Provide central documents required for HA/EC/IRB submission
• Ensures creation of appropriate trial-specific training materials and requirements
• Responsible for the set-up, coordination, attendance, and participation of Investigator Meetings
• Establish and maintain excellent working relationships with internal stakeholders
• Demonstrate deep knowledge of protocol and procedures and adequate therapeutic area knowledge
• Ensure compliance with Health Authority regulations and guidelines and internal standard operating procedures and processes
• Participate in preparation for, and conduct of, Health Authority inspections and internal audits
• Work with Bioresearch Quality & Compliance (BRQC) liaisons to ensure quality oversight of assigned trial
• Coordinate data cleaning with some supervision towards a timely and successful database lock
• Act as central expert for assigned protocol(s)
• Sufficient therapeutic knowledge to support defined CTM roles and responsibilities
• Contribute to process improvement and training, as applicable

Requirements:

• BS degree or equivalent, in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy)
• 6-8 years clinical trial management experience in the pharmaceutical industry or CRO
• Specific therapeutic area experience
• Strong working knowledge of ICH-GCP, local laws and regulations
• Superior clinical research operational knowledge
• Proven track record in successfully managing various aspects of trials from start-up to database lock and trial closure
• Demonstrated effective leadership to proactively drive the Study Management Team through key stages of trials
• Effective leadership skills and ability to manage multiple stakeholders
• Proven ability to lead a team through formation stages, up to operating as a high-performing team
• Experience and ability in coordinating global or regional teams in a virtual environment
• Proven ability to foster team productivity and cohesiveness
• Experience and ability in coordinating global teams in a virtual environment for a minimum of 2, preferably 3 years
• Proven experience in proactive planning, risk mitigating, and gaining team consensus on updated plans during the project lifecycle
• Strong project planning/management
• Independent complex decision-making
• Solution-oriented and proactive risk identification and mitigation
• Strong IT skills, including knowledge of standard Microsoft applications, Trial Master File, Clinical Trial Management System
• Monitoring experience is recommended, or other relevant experience should be considered
• Travel
• Proficient in speaking and writing local country language and English
• Effective verbal and written communication skills leading to successful team collaboration
• Strong decision-making
• Solution-oriented
• Strong analytical skills, and simultaneously demonstrates the ability to manage ambiguity when limited information is available
• Experience in developing presentations and presenting key information to stakeholders
• Ability to understand and competently plan and have oversight of country and select vendor budgeting processes