Lead, Trial Delivery Management

• Execute study-level activities
• Create and update trial-specific documents, including Monitoring Guidelines, Informed Consent Forms, and Investigational Medicinal Product documentation
• Manage vendor setup and day-to-day study vendor activities, including statements of work and budget oversight
• Coordinate and oversee country/regional trial management activities
• Align feasibility strategy with local teams and perform country-level risk reviews
• Support development of program-level compound training in collaboration with Clinical, CTL&D, and Medical Writing
• Provide input into trial-level operational strategies
• Resolve trial-related issues and mitigate trial-related risks
• Participate in process improvement activities at trial, compound, and cross-DU levels
• Support Health Authority inspections and identify program-level risks and mitigation plans
• Mentor and support onboarding of new team members, particularly in Trial Management

• BS degree or equivalent, preferred areas of study include Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy)
• Minimum of 4 years clinical trial experience in Pharmaceutical, Healthcare or related industries
• Clinical research operational knowledge and experience across multiple phases of studies (Phase I-IV)
• Ability to manage multiple aspects of execution of a clinical trial
• 2-3 years’ experience supporting multiple aspects of a global clinical trial
• Excellent leadership skills and proven ability to foster team productivity and cohesiveness
• Experience leading without authority and in multifunctional, matrixed and global environments
• Excellent decision-making, analytical and financial management skills
• Ability to operate and execute with limited supervision
• Experience mentoring/coaching others
• Strong project planning/management, communication and presentation skills
• Preferred related industry experience:
  Pharmaceutical, Biopharmaceutical, Biotechnology
• Analytical Reasoning
• Clinical Research and Regulations
• Clinical Trial Designs
• Clinical Trial Management Systems (CTMS)
• Clinical Trials
• Data Savvy
• Laboratory Operations
• Organizing
• Problem Solving
• Productivity Planning
• Professional Ethics
• Project Integration Management
• Quality Assurance (QA)
• Regulatory Compliance
• Research and Development
• Research Ethics
• Standard Operating Procedure (SOP)

Demonstrates expertise in clinical trial management, including the creation of trial-specific documents and oversight of vendor activities. Possesses strong leadership, analytical, and project management skills to effectively execute and support global clinical trials.

• Clinical Trial Management
• Clinical Research Operational Knowledge
• Project Planning/Management
• Regulatory Compliance
• Leadership Skills

• Clinical Trial Designs
• Clinical Trials
• Clinical Trial Management Systems (CTMS)
• Data Savvy
• Quality Assurance (QA)
• Regulatory Compliance
• Analytical Reasoning
• Problem Solving
• Productivity Planning
• Standard Operating Procedure (SOP)

• Excellent Leadership Skills
• Communication Skills
• Decision-Making Skills
• Mentoring/Coaching Skills
• Organizing

• Pharmaceutical
• Biopharmaceutical
• Biotechnology
• Healthcare
• Life Sciences