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Head Clinical Vendor Management & Operations Lead

Company: Mindlance
Location: Somerville
Posted on: June 21, 2022

Job Description:

Job DescriptionSummary of Key Responsibilities:
--- Leads global team supporting key functions (e.g. systems & metrics, TMF, resource planning) o Responsible for the guidance of clinical staff, including hiring, performance management and ongoing coaching. o Responsible for shaping the Clinical Operations team culture including the retention and engagement of team members. o 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
o Participate in strategic relationship oversight, management, and issue resolution o Point of escalation for execution or quality issues related to conduct of studies by strategic partners or vendors
o Leads Joint Operating Committees and Executive Steering Committees in partnership with relevant stakeholders
o 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.
o Oversight of the Systems and Metrics infrastructure
o Identifies and drive the implementation of key information technology, business systems, data requirements and other key vendor systems integration
o Generates relevant reporting and dashboards
o Supports systems initiatives through evaluation, documentation and recommendation of systems requirements and operational impact
o Provides subject matter expertise to perform pre- and post-implementation due diligence for systems initiatives.
o Develops, generates, and analyzes data/metrics/key performance indicators to support the management clinical trials.
o Plans, tracks and manage progress of yearly goals/objectives.
o Provides study milestone reporting o 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
o Connects work streams and initiatives that might otherwise remain siloed o Integrates Clinical Operations initiatives with the broader organization
o 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 o Oversight and reporting of actual spend and resource utilization
o 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 directionQualifications
--- 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: 22-47707 : Cambridge, NJ:

Keywords: Mindlance, Somerville , Head Clinical Vendor Management & Operations Lead, Healthcare , Somerville, Massachusetts

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