The Head of Vendor Management & Operations Lead is accountable for the management of our CRO strategic providers and vendors. S/he will work directly with Expertise Areas and vendors to provide high quality, best in class services for our clinical trials.
The individual is responsible for implementing and maintaining Clinical Operations systems and metrics that support efficient and effective delivery of clinical trials.
The Head of Vendor Management & Operations Lead is accountable for Trial Master File support of Clinical Operations, Clinical Development & Medical Affairs. The individual oversees adherence to regulatory requirements and GCP guidelines.
The individual facilitates the Clinical Operations annual investment and workforce planning, quarterly forecasting, and oversight of actual spend. S/he partners with Clinical Operations Leadership Team, Clinical Development Business Operations, Finance and Procurement.
The Head of Vendor Management & Operations Lead is an effective team leader. The individual is responsible for the talent development, provides line management and supervision of team members in the group. The individual is also a member of the Clinical Operations Leadership Team and as such supports and influences the direction of the Clinical Operations group. The individual collaborates with team members to drive strategic team decision-making and deliver on commitments to the organization and to patients.
Summary of Key Responsibilities.
- Leads global team supporting key functions (e.g. systems & metrics, TMF, resource planning)
- Responsible for the guidance of clinical staff, including hiring, performance management and ongoing coaching.
- Responsible for shaping the Clinical Operations team culture including the retention and engagement of team members.
- Acts as point of contact for leadership including resolution or escalation of issues as appropriate.
- Manages relationships with key CRO strategic partners, vendors and their leadership teams
- Participate in strategic relationship oversight, management, and issue resolution
- Point of escalation for execution or quality issues related to conduct of studies by strategic partners or vendors
- Leads Joint Operating Committees and Executive Steering Committees in partnership with relevant stakeholders
- Identifies new business opportunities to collaborate with strategic partners
- Monitors the health of the relationships including performance, financial and culture; takes appropriate actions
- Establishes criteria to measure the overall health of Clinical Operations, trial delivery and vendor performance.
- Oversight of the Systems and Metrics infrastructure
- Identifies and drive the implementation of key information technology, business systems, data requirements and other key vendor systems integration
- Generates relevant reporting and dashboards
- Supports systems initiatives through evaluation, documentation and recommendation of systems requirements and operational impact
- Provides subject matter expertise to perform pre- and post-implementation due diligence for systems initiatives.
- Develops, generates, and analyzes data/metrics/key performance indicators to support the management clinical trials.
- Plans, tracks and manage progress of yearly goals/objectives.
- Provides study milestone reporting
- Participates in key cross functional teams such as fair market value (FMV)
- Oversee Clinical Operations strategic initiatives and capabilities planning to scale for the future
- Connects work streams and initiatives that might otherwise remain siloed
- Integrates Clinical Operations initiatives with the broader organization
- Communicates these efforts by linking with the leadership team and extended Clinical Operations team
- Oversees the Trial Master File and Document Management system; ensures inspection ready TMF
- Facilitates investment and workforce planning, quarterly forecasting
- Oversight and reporting of actual spend and resource utilization
- Expenditures against department budget as they relate to this role
- Active participation as a member of the Clinical Operations Leadership Team in driving strategy and team execution
- Actively participates and/or leads in the development of the Clinical Operation department’s vision, standards and successful implementation of process improvements and change.
- Instills a culture of continuous improvement; acts as a change champion and effectively leads change.
- Maintain awareness of biopharmaceutical business, operational trends, and external organizational developments to help define future strategic direction.
- University Degree in Science or related discipline. A higher degree would be desirable.
- Extensive (minimum 15+years) experience with a CRO or biopharmaceutical company and track record of success in global clinical operations or related disciplines.
- Significant (10+ years) line management experience.
- Experience in leading global and/or remote based teams.
- Strong knowledge of global regulatory and compliance requirements for clinical trials.
- Extensive experience with CRO and vendor management
- Extensive knowledge of relevant IT applications and understanding of technologies to support job function; system and metrics experience
- TMF leadership
- Experience in the clinical drug development process within clinical program planning through final study report.