Senior CRA Functional Manager

This is a fully remote position, open to applicants in United States.

📋 Description

• Formulate resourcing strategies and provide oversight for personnel within the Site Management team.

• Create metrics and KPIs for CRA personnel and track ongoing enhancements utilizing technology and analytical platforms.

• Lead CRA Managers and their teams, ensuring accountability for study assignments, training, and performance reviews.

• Offer performance management, coaching, and mentoring to designated management personnel.

• Ensure that monitoring expectations adhere to monitoring SOPs, GCP guidelines, country-specific regulations, and standards for quality and risk-based effectiveness.

• Conduct assessments, co-monitoring visits, Investigator meetings, or Booster visits as necessary to evaluate CRA personnel.

• Propel improvements to enhance effectiveness and efficiency within Site Management and the broader Americas region.

• Supervise monitoring quality and associated metrics, including trip-report turnaround, trip-report quality, action-item management, query management, data currency, and TMF management.

• Maintain relationships with CRO FSP line managers and address feedback related to direct reports, studies, and programs.

• Serve as an escalation point for CTOMs and study teams regarding CRA-related issues and concerns.

• Ensure appropriate monitoring allocations and relevant training for the projects of direct reports.

• Support BeiGene RBx strategy and the engagement of direct reports.

• Record monitoring oversight activities in accordance with ICH-GCP and BeOne standards.

• Assist in the identification of investigators and sites.

• Analyze site trends through dashboard reviews and continuous risk assessments.

• Collaborate with clinical study teams and sites to achieve study milestones, including initiation, recruitment, database analyses, and closure.

• Establish communication with stakeholders to manage clinical delivery and report or escalate issues as necessary.

• Review monitoring reports to ensure quality oversight.

• Support site audits and inspections and address findings until resolution.

⛳️ Requirements

• BS/BA in a relevant scientific field.

• A minimum of 8-9 years of pertinent Clinical Operations experience.

• 4-5 years of combined personnel and trial management experience.

• At least 4-5 years of monitoring experience.

• Experience in global oncology trials is preferred.

• Knowledge of monitoring SOPs, GCP guidelines, country-specific regulations, and quality and risk-based monitoring.

• Proficient in developing metrics and KPIs.

• Capable of conducting performance management, coaching, and mentoring.

• Skilled in managing relationships with CRO FSP line managers.

• Ability to collaborate with CTOMs, Clinical Study Teams, investigators, and both internal and external stakeholders.

• Competent in supporting site audits and inspections and resolving findings.

• Familiarity with ICH-GCP and BeOne standards.

🏝️ Benefits

• Eligibility for an annual bonus plan for non-commercial roles.

• Eligibility for an incentive compensation plan for commercial roles.

• Discretionary equity awards.

• Optional participation in the Employee Stock Purchase Plan.

• Medical insurance.

• Dental insurance.

• Vision insurance.

• 401(k) plan.

• FSA/HSA options.

• Life Insurance.

• Paid Time Off.

• Wellness programs.