Job Summary: The Head, Project Management (HPM) oversees the project execution, and management of clinical research trials sponsored by the pharmaceutical industry while adhering to budget, quality, scope of work, and timelines. The HPM will oversee professional development, training, resourcing, and allocation of the project management team. They are expected to provide day-to-day supervision of the clinical PM team, and are responsible for PM processes, procedures, and systems.
Reports To: Chief Operating Officer
Experience Profile:
• Outstanding knowledge and experience in the clinical research field
• Extensive experience managing full-service clinical trials in a CRO or Pharma company
• Experience directing and overseeing project managers and their project delivery
• Possess exceptional written and verbal communication skills
• Strong organizational, problem-solving, and analytical skills
• Exceptional knowledge of management best practices and strong managerial skills
• Scientific and regulatory experience and knowledge
• Demonstrated ability to review and assess work with excellent attention to detail
• Technical expertise in trial management, clinical operations, and regulatory process
• Strong interpersonal skills, reliable team player
• Demonstrated time management and decision-making skills
• Global experience strongly preferred
• Good conflict resolution and problem-solving skills
Principle Duties and Responsibilities:
• Manage staff in accordance with organization’s policies and applicable regulations
• Provide operational support for project management team
• Oversee PMs including assessing quality, financial health, and customer relations
• Participate in business development activities, including proposal pricing and bid defense meetings
• Plan, assign, and direct work, appraise performance, guide professional development, address employee relations issues, and resolve problems
• Oversee hiring of PM staff and participate in hiring of all clinical staff as appropriate
• Display passion, inspire respect and trust, and mobilize others to fulfill the vision
• Allocate resources by assigning appropriate staff based on experience and training
• Manage the quality of project manager’s work through regular review and evaluation of work product
• Proactively identifies quality risks and issues and creates corrective action plans
• Maintains high standards despite pressing deadlines; regularly produces accurate, thorough, and professional work and adheres to a high level of ethical oversight
• Ensure that staff is meeting defined workload, quality and budget metrics through regular review and reporting of findings as outlined by senior management
• Participates in corporate or organizational quality or process improvement initiatives
• Act as a client liaison in day-to-day relationship governance, escalations, and other client-facing initiatives
• Analyze and review budgets for clinical studies and manage study budget
• Serve as program director for complex projects in order to assure applicable regulations, SOPs, and sponsor requirements are met, if needed
• Develop and implement SOPs in accordance with regulatory guidelines and GCP
• Ensure efficiency in collaboration with study sites and consultants
• Provide input during planning and execution of clinical trials
• Oversee PM systems and plan/manage system updates and transitions
• Develop and manage vendor relationships
• Other duties as assigned
Qualifications
• Bachelor’s degree required; Advanced degree (Master’s, Ph.D., MBA, etc.) in scientific discipline or health care preferred
• At least 10 years clinical trials experience including at least 5 years of experience in a management/leadership capacity
• Advanced knowledge and ability to apply GCP/ICH and regulatory guidelines
• Strong knowledge of clinical research financial parameters and accounting methods for forecasting, budgeting, and proposal generation
• Ability to anticipate critical issues and develop contingency plans proactively
• Strong leadership skills
• Effective presentation skills
• Effective time management skills and ability to manage competing priorities
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients
• Knowledge of clinical trial management software products (e.g., CTMS, EDC, etc.)
• Strong customer relation management and negotiation skills
• Strong personal values and ethical standards