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Associate Director, Site Management Operations, Program Lead

New Jersey All, NJ

Posted: 03/12/2019 Job Type: Clinical Job Number: JN -032019-23911
  • Management and oversight of site monitoring deliverables and interfacing with Clinical Trial Teams on all aspects of study execution
  • Leads cross-functional efforts to identify and manage study and site-level risks and to identify and implement risk mitigation strategies
  • Ensures that Regional Operations Managers and Regional Site Managers are implementing site level risk mitigation strategies
  • Provides leadership and content expertise for site management and monitoring activities from study startup through the study closeout stage of clinical studies to effectively oversee resources, timelines, quality, and data delivery supporting database lock activities including:
    • Site selection & activation
    • Site recruitment
    • Protocol compliance, safety reporting, & data quality
    • Timely data entry and query management
    • Action item resolution
    • Adherence to PSMP
    • Protocol risk assessment & issue management
    • Oversight of key risk indicators
    • Maintain study and site inspection readiness at all times
    • Provides status reporting on deliverables to Senior Management and Cross functional Groups
  • Key contact for Feasibility Analytics in Clinical Trials, Global Clinical Trial Management, Global Site Management Operations, Clinical Data Management & Programming, Global Patient Safety & Epidemiology, Global Clinical Supplies Management, Clinical Development, and Non-Translational Sciences as applicable related to Site Management & Monitoring on assigned studies
  • Responsibilities include participating in the vendor selection process and managing vendors (e.g. CROs, FSPs, Technology Providers, etc.)
  • Involvement in assessment/reassessment of vendor capabilities, as necessary
  • May participate in bid defense meetings & scope of work review
  • Accountable for supervising CRO oversight for assigned outsourced studies
  • Ensures CRO oversight is conducted consistently across all programs
  • Key contact for R&D Sourcing and Clinical Vendor Oversight related to Site Management & Monitoring and CRO oversight on assigned studies
  • Responsibilities include the implementation of quality, efficient, and consistent approaches to carrying out site management & monitoring tasks
  • Drives and contributes to continuous improvement
  • Delivers training and other functions/departments as necessary
  • Provides mentoring and support to new Program Leads
  • Supports Corrective and Preventative (CAPA) Action initiatives as needed
Minimum Requirements
  • Bachelor s Degree
  • Significant clinical research experience within a site management operations & monitoring leadership role in the pharmaceutical/device industry or CRO (preferably within a medium/large pharma or CRO)
  • Previous field monitoring experience
  • Program Management experience
  • Advanced knowledge of research and development, clinical trials execution, and understanding of regulatory requirements/guidelines (e.g. ICH, GCP, safety reporting)
  • Advanced knowledge and understanding of project management guidelines & related concepts including experience managing large global projects
  • Advanced knowledge of global standards related to site management & monitoring activities (institutional review board or ethics committee reporting requirements, local regulations, risk based monitoring practices)
  • Excellent ability to work in a matrix environment and communicate effectively with different functional groups across the organization from a field based office location including home based office
  • Excellent ability to foster open communication and practice active listening to encourage a collaborative team environment
  • Demonstrates excellent negotiation skills, innovating thinking & a solution oriented approach to problem solving and a can do attitude
  • Ability to travel overnight up to 30% of time
  • Must be able to maintain the necessary travel documents (e.g. valid driver s license, passport, visa)
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