Clinical Trials Management Director

Benefits

Qualifications

• •Bachelor’s or advanced degree, preferably in life sciences, pharmacy, or a related field
• •Minimum 10–15 years (without Master’s) or 8–12 years (with Master’s) of relevant experience in biotech/pharmaceutical or CRO setting, with experience supporting Phases 1–4 clinical studies
• •Must be able to exercise appropriate judgment as necessary
• •Requires a high level of initiative and independence
• •Excellent written and oral communication skills required
• •Requires the ability to use a personal computer for extended periods of time
• •Fast-paced environment handling multiple demands is involved
• •Must be able to exercise appropriate judgment as necessary
• •Requires a high level of initiative and independence
• •Excellent written and oral communication skills required
• •Requires ability to use a personal computer for extended periods of time
• •Must be able to travel domestically and internationally as needed
• •Drug Screening Requirements
• •Applicants for sales/field, manufacturing, or other designated roles will be required to submit to a pre-employment drug test
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Responsibilities

• •Direct the end-to-end planning, execution, monitoring, and successful completion of one or more clinical studies within a program(s), ensuring adherence to timelines, budgets, and quality standards
• •Oversee the development and control of key study documents and plans (e.g., protocols, informed consents, clinical study reports), ensuring alignment with GCP and regulatory requirements
• •Oversee Trial Master File (TMF) set-up, maintenance, and completeness to ensure inspection readiness; collaborate with relevant functions to support data completeness and accurate reporting
• •Proactively identify, manage, and mitigate study/program risks and issues; lead quality and compliance activities with cross-functional teams and vendors to drive continuous improvement
• •Develop, manage, and refine budgets, forecasts, and financial reporting for the assigned program(s), ensuring appropriate oversight and control
• •Serve as the clinical operations' functional representative on cross-functional program teams; facilitate effective communication and collaboration across departments and with external partners
• •Provide subject matter expertise for departmental initiatives and process improvement efforts; contribute to the development and refinement of clinical operations policies, procedures, and resourcing strategies
• •Provide oversight in the selection, onboarding, training, and performance management of study personnel, CROs, and other vendors to ensure delivery against contracts, expectations, and program objectives
• •Manage direct reports (as applicable) through coaching, mentorship, and performance feedback; collaborate with Clinical Operations leadership to align program-level activities with departmental goals and strategy
• •Implement clinical development principles and industry standards, including GCP and ICH guidelines
• •Understands drug development and the end-to-end clinical trial lifecycle (protocol/feasibility through close-out and reporting)
• •Experience as a clinical operations lead
• •Interprets applicable regulations and literature and stays current on evolving GCP/ICH expectations and inspection readiness
• •Communicates effectively with internal stakeholders, sites, vendors, and consultants, including translating scientific/medical concepts
• •Produces clear documentation (e.g., reports and procedures) and presents information effectively to groups
• •Solves problems and makes decisions in situations with limited standardization and multiple variables
• •Strong cross-functional collaboration across diverse, global teams and leads through influence/coaching in a management role
• •Manages multiple vendors/contractors and coordinates partners to deliver study objectives
• •Prioritizes and delivers across competing timelines; manages time and multiple tasks
• •Demonstrates organizational awareness and connects interdependencies to maintain the broader program perspective
• •Primarily remote role with periodic on-site meetings
• •Must be able to travel domestically and internationally as needed
• •Fast-paced environment handling multiple demands is involved
• •All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed
• •Confidential Data: All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential, in accordance with applicable law
• •Primarily remote role with periodic on-site meetings in office
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