Director – Clinical Trial Management

Director – Clinical Trial Management

Requirements

• Demonstration of advanced project/program management skills including timeline and budget management, risk assessment and contingency planning.
• Proven track record of successfully overseeing staff to execute and deliver clinical trials on time and on budget, ensuring inspection readiness throughout.
• Excellent understanding of GCP, CFR and ICH Guidelines.
• Effective team leadership in cross-functional study and program teams, with demonstrated strength in team building.
• Significant experience with direct line management of employees.
• Excellent verbal and written communication skills, organizational skills, problem solving and conflict resolution skills.
• Strong interpersonal skills and demonstrated ability to effectively interface successfully with external parties, including key medical personnel at investigational sites, Key Opinion Leaders, vendors and Patient Advocacy groups.
• Excellent presentation skills with ability to adapt communication and content appropriately based on the intended audience.
• Self-motivated and proactive with ability to work independently in highly time sensitive environment.
• Proficiency in Microsoft Office applications including Microsoft Project, Outlook, Excel, Word and PowerPoint.
• Bachelor’s degree in life sciences discipline or related discipline
• Typically requires 12 years of experience executing clinical trials globally across all phases of development and 3 years of supervisory/management experience, or the equivalent combination of education and experience.

Responsibilities

• Represents GCO as a key Program Team member, responsible for the development and execution of clinical development plans in conjunction with the Program Teams.
• Manages Clinical Trial Managers with responsibility for recruitment, resourcing, training, performance management, employee goal setting and career development. May also manage contract staff.
• Develops operational strategy (study scenario planning, operational decision points and risks, initial study timeline, study financials) for assigned program(s).
• Accountable for operational delivery of all clinical trials within program lifecycle, overseeing cross-functional alignment, budget, and timeline from protocol generation through completion of the clinical study report, ensuring quality and a focus on inspection readiness throughout.
• Proactively identifies study and program risks and implements contingency plans, providing regular updates on study status to GCO Leadership Team and senior stakeholders in GMDA.
• Participates in vendor identification and oversees Clinical Trial Managers in vendor set up and oversight.
• Active involvement in investigator identification and selection, including the expansion to new geographies.
• Provides oversight on the development of study documentation, including clinical trial protocols, study plans and clinical study reports.
• Participates in cross functional study data review where appropriate.
• Develops departmental goals and objectives for Clinical Trial Management.
• Tracks key performance indicators and departmental metrics for Clinical Trial Management and identifies opportunities to optimize processes and procedures (SOPs, Work Instructions).
• Leads cross-functional initiatives
• Serves as representative for Clinical Trial Management on vendor-related Joint Operating Committees.

Preferred Qualifications

No preferred qualifications provided.