Job Information
BeiGene Associate Director, CRA Functional Manager in San Mateo, California
General Description:
The AD. CRA Manager provides/supports resourcing strategy and personnel oversight within the Site Management organization
The AD. CRA Manager develops/supports metrics and KPIs for CRA staff addressing new technology and analytic platforms monitoring for continuous improvement with output and results.
The AD. CRA Manager provides/supports leadership for the CRA Managers and their staff ensuring accountability for study assignments, training, and metrics review.
The AD. CRA Manager provides performance management, coaching and mentoring for their assigned staff.
The AD. CRA Manager ensures proper monitoring expectations in collaboration with CTOMs; including but not limited to adherence to monitoring SOPs, GCP guidelines, country-specific regulations, and general quality and risk-based effectiveness
The AD. CRA Manager may complete assessments visits for assigned staff as required and as contracted.
Proactively seeks opportunities to lead and drive improvements to optimize effectiveness and efficiencies within the Site Management organization as well as within the greater Americas region
May also provide leadership to managers and professional staff
May also be accountable for the performance and results of multiple related teams
Supports SR Director to develops departmental plans, including business, production and/or organizational priorities
Decisions are guided by resource availability and organizational objectives
Essential Functions of the job:
The following functions may apply based on study and program requirements:
Responsible for efficient resourcing strategy within Americas region for CRA staff
Responsible for leading across CRA Managers
Responsible for developing/supporting metrics and KPIs for CRA staff
Responsible for CRA oversight with regard to Functional Management related to projects direct reports are assigned to
Responsible for performance management of BeiGene assigned staff
Responsible for oversight of monitoring quality, metrics associated with monitoring including but not limited to: trip report turn around metrics, quality of trip report, action item management, query management, data currency and TMF management
Responsible for managing relationship with CRO FSP line manager and liaising to understand and respond to feedback regarding individual direct reports or feedback about BeiGene studies or programs.
Acts as the escalation point person for CTOM(s) and study teams with CRA related issues and concerns
Works with CTOMs to ensure adequate monitoring allocations and relevant training are correctly assigned for direct reports’ projects.
Supports BeiGene RBx strategy and ensure engagement of direct reports.
May conduct, attend, or support co-monitoring visits, as needed or as necessary to evaluate CRA staff
May attend, or support at Investigator meetings or Booster type visits to evaluate CRA staff
Documents monitoring oversight activities appropriately following ICH-GCP and BeiGene standards
Assists with investigator/site identification
Working with CTOMs and Clinical Study Team (CST), manages site trends through dashboard review and ongoing risk assessment to ensure quality standards and address concerns associated with study delivery at sites.
Collaborates with CST and clinical study sites to ensure timely delivery of study milestones (i.e., study startup, recruitment, database analyses, closeout, etc.)
Establishes regular lines of communication with CST, CTOMs and additional internal and external stakeholders to manage CRA clinical delivery and report/escalate any issues to the COM. Clinical Operations
Assists in review of Monitoring reports with regard to quality oversight as needed
Provide support for site audits/inspections, as needed, and follow-through with audit/inspection findings to resolution as it related to involved CRA staff
Supervisory Responsibilities:
May include supervision of CRA Management staff
Supervision of CRA staff
May supervise other roles as required within Site Management organization
Support Director/Sr. Director to oversees resourcing output managing Head count to need and addressing projected work
Oversees/Supports metrics and KPI for CRA staff in the Americas
Provides necessary training to CRA management staff and CRA staff
Co-monitoring as necessary with CRAs to ensure oversight and address site-related concerns
Assists with the identification of development opportunities for junior team members
Education Required:
BS/BA in a relevant scientific discipline and minimum of 8 years of relevant Clinical Operations experience; > 5 of those a combination of personnel and trial management experience, and minimum of 5 years of monitoring experience. Experience in oncology global trials preferred.
Computer Skills:
Efficient in Microsoft Word, Excel, PowerPoint, Teams and Outlook
Familiar with industry CTMS and data management systems
Other Qualifications:
Understands clinical trial processes with a thorough knowledge of ICH and associated regulatory guidelines
5 years of management or oversight within pharmaceutical or CRO Industry
4-5 > 5 years of (CRA) monitoring experience in the pharmaceutical or CRO Industry
Excellent communication and interpersonal skills
Excellent organizational skills and ability to prioritize and multi-task
Travel: up to 15-25% time
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.