Senior CRA Functional Manager

BeiGene

12d•$136,400 - $181,400

About The Position

The Senior CRA Manager provides resourcing strategy and personnel oversight within the Site Management organization. This role leads CRA Managers and their teams, develops CRA metrics and KPIs, and oversees staff performance, training, study assignments, and monitoring quality. The position works with CTOMs and study teams to support monitoring expectations, adherence to SOPs, GCP guidelines and country-specific regulations, and continuous improvement across the Site Management organization and the Americas region. The role oversees CRA functional management for assigned projects, including monitoring metrics, risk-based quality, site trends, and CRA-related escalations. It collaborates with Clinical Study Teams, CTOMs, CRO FSP line managers, study sites, and other stakeholders to support study milestones and resolve issues. The manager may conduct or support co-monitoring visits, investigator meetings, audits, and inspections, and documents oversight activities according to ICH-GCP and BeiGene standards. Candidates should have a BS/BA in a relevant scientific discipline and substantial Clinical Operations, personnel or trial management, and monitoring experience. Experience in global oncology trials is preferred. Salary is $136,400 to $181,400 annually. Non-Commercial roles are eligible for an annual bonus plan; Commercial roles are eligible for an incentive compensation plan. Employees may receive discretionary equity awards and may voluntarily participate in the Employee Stock Purchase Plan. Benefits include medical, dental, vision, 401(k), FSA/HSA, life insurance, paid time off, and wellness. Actual compensation depends on candidate-specific factors and work location.

Requirements

BS/BA in a relevant scientific discipline.
A minimum of 8–9 years of relevant Clinical Operations experience.
4–5 years of combined personnel and trial management experience.
A minimum of 4–5 years of monitoring experience.
Ability to apply monitoring expectations, SOPs, GCP guidelines, country-specific regulations, and quality and risk-based approaches.
Global competencies include fostering teamwork; providing and soliciting honest, actionable feedback; self-awareness; acting inclusively; demonstrating initiative; entrepreneurial mindset; continuous learning; embracing change; results orientation; analytical thinking and data analysis; financial excellence; and communicating with clarity.

Nice To Haves

Experience in oncology global trials.

Responsibilities

Develop efficient CRA resourcing strategies for the Americas region.
Lead CRA Managers and oversee CRA staff, including study assignments, training, performance management, coaching, and mentoring.
Develop metrics and KPIs for CRA staff and use them to monitor continuous improvement and results.
Provide functional management oversight of CRA work on assigned projects.
Oversee monitoring quality and related metrics, including trip report turnaround and quality, action-item management, query management, data currency, and TMF management.
Manage relationships with CRO FSP line managers and respond to feedback concerning direct reports, studies, or programs.
Serve as an escalation point for CTOMs and study teams on CRA-related issues and concerns.
Work with CTOMs to ensure monitoring allocations and relevant training are assigned to direct reports' projects.
Support BeiGene's RBx strategy and ensure engagement of direct reports.
Conduct, attend, or support co-monitoring visits as needed to evaluate CRA staff.
Attend or support investigator meetings or booster visits to evaluate CRA staff.
Document monitoring oversight activities according to ICH-GCP and BeiGene standards.
Assist with investigator and site identification.
Work with CTOMs and the Clinical Study Team to manage site trends through dashboard review and ongoing risk assessment.
Collaborate with the Clinical Study Team and clinical study sites to support timely study milestones, including startup, recruitment, database analyses, and closeout.
Maintain communication with the Clinical Study Team, CTOMs, and other stakeholders regarding CRA clinical delivery, and report or escalate issues to the COM, Clinical Operations.
Assist with review of monitoring reports for quality oversight as needed.
Support site audits and inspections as needed and follow audit or inspection findings related to CRA staff through resolution.
Proactively identify and lead improvements to optimize effectiveness and efficiency within Site Management and the greater Americas region.