Role is responsible for strengthening the risk-based monitoring approach/practices and the applied oversight of our vendors. This highly specialized role, focused on monitoring excellence across the portfolio, will develop solutions to fuel a high-performing practice from study initiation through site closure. With a strong emphasis on inspection readiness and compliance, this leader will drive the relevant risk management framework and contribute to the internal education of personnel on the compliant management of monitoring in clinical trials globally.
The role requires regular contact with persons of influence and in decision-making positions within R&D and with CROs. As such, The Director Clinical Ops Risk Management requires strong oral and written communications expertise, and the ability to influence while obtaining desired outcomes in a goal-oriented environment. Ability to work independently and deliver results throughout the cross-functional network is critically important.
As the process owner, designs, implements and maintains Immunomedics risk-based monitoring guidelines and practices.
In context of vendor oversight, creates the quality plan for checking CRO delivery related to site activities.
Partners with Clinical QA to ensure a state of inspection readiness through monitor plan documentation, relevant vendor oversite plans, and study specific materials as evidence of regulatory compliance.
Establish, manage and report vendor monitoring KPIs; report to management on regular basis.
Reviews protocols, as well as CRO task orders for monitoring input & risks.
Owns development/maintenance on internal SOPs related to identification and management of risk-based monitoring, and the alignment with CRO SOPs.
Partners with Clinical Digital Solutions to deliver monitoring dashboards of relevance from our CTMS tool, and in alignment with our CROs.
Over the long-term, partners with Clinical Data Management in the development of strategic pathways for optimizing risk-based management procedures, technologies and reporting across the portfolio
Responsible for meeting the strategic monitoring aims, business case and annual objectives for both internal and external relationships.
Focuses on external alliance relationship via the governance bodies for strategic alliances where appropriate.
Assess monitoring staffing forecast information to Clin Ops management to support short and long-term portfolio resource allocation.
Stays abreast and effectively communicates of industry trends in Clinical Monitoring Management, identifies process/SOP implications as well as training needs/implications for relevant staff
Participate in driving operational business change, within Clinical Operations organization and across the broader organization. This will involve implementing and developing ways of working, to ensure we get the best value and standards of delivery through external service providers
No formal direct reports. Will direct activities across the portfolio working with Clin Ops study team leaders in the attainment of department goals.
BA/BS in Business or Life Sciences; Masters level preferred.
15+ years directly related experience in pharmaceutical industry, or equivalent.
10+ years with deep subject matter expertise in clinical monitoring, outsourced vendor management and analysis of clinical operations site related risks and demonstrated knowledge of the associated processes.
Proven ability to lead critical portfolio wide initiatives coupled with experience partnering with vendors/strategic partners while ensuring quality deliverables in a cost-effective manner.
Experience creating key performance indicators, and other metrics, that are fit for purpose in alignment with the relevant audiences. Experience in the delivery of these indicators up through senior management. Demonstrated ability to gather information from multiple sources and analyze applicability and appropriateness to develop new workflows. Demonstrated technical, organizational, project management, and negotiation skills.
Extensive knowledge of site/monitoring best practices from study initiation through site close-out. Strong expertise in risk-based monitoring approaches. Broad understanding of drug development process along with depth of knowledge in clinical operations/clinical data process utilized to deliver quality documents/data.
Solid understanding of US and global regulations and guidelines (e.g., FDA, EMA, ICH) applicable to clinical operations.
Ability to apply strategic direction to a team or project and gracefully manage through unexpected events and competing priorities.
Demonstrated excellent written and verbal communication skills, negotiation, collaboration, conflict management and interpersonal skills
Extensive cross-functional drug team participation. With demonstrated understanding of the roles of critical functions in the team operations. Ability to solve highly complex problems and develop solutions to projects or tasks which may be unique.
Demonstrated ability to establish and maintain positive and productive working relationships throughout the enterprise and with external vendors. Highly motivated and results oriented
Strong knowledge of oncology and autoimmune disease.
Strong evidence of living the Immunomedics' values Operates effectively under deadlines and extreme workloads. Previous experience leading key strategic functional initiatives and change management activities.