Senior CRA Functional Manager

Há 1 mês

São Paulo, Brasil BeiGene Tempo inteiro

BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

General Description:

The Sr. CRA Functional Manager provides resourcing strategy and personnel oversight within the Site Management organization; develops metrics and KPIs for CRA staff addressing new technology and analytic platforms monitoring for continuous improvement with output and results; provides leadership for the CRA Managers and their staff ensuring accountability for study assignments, training, and metrics review; provides performance management, coaching and mentoring for their assigned management staff; ensures proper monitoring expectations in collaboration with other GCO functions; including but not limited to adherence to monitoring SOPs, GCP guidelines, country-specific regulations, and general quality and risk-based effectiveness​; 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

Essential Functions:

The following functions may apply based on study and program requirements:

Responsible for efficient resourcing strategy within LATAM region for CRA staff Responsible for leading CRA Managers, if applicable Responsible for developing 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. Works with other GCO functions 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

Minimum Requirements – Education and Experience:

BS/BA in a relevant scientific discipline and minimum of 8-9 years of relevant Clinical Operations experience; 4-5 of those a combination of personnel and trial management experience, and minimum of 4-5 years of monitoring experience. Experience in oncology global trials preferred.

Other Qualifications:

Understands clinical trial processes with a thorough knowledge of ICH and associated regulatory guidelines 4-5 years of management or oversight within pharmaceutical or CRO Industry 4-5 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

Supervisory Responsibilities:

Supervision of CRA Management staff Supervision of CRA staff May supervise other roles as required within Site Management organization Oversees resourcing output managing Head count to need and addressing projected work Oversees 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

Travel:  up to 15-25% time

Computer Skills:

Efficient in Microsoft Word, Excel, and Outlook Familiar with industry CTMS and data management systems

BeiGene Global Competencies

When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

Fosters Teamwork Provides and Solicits Honest and Actionable Feedback Self-Awareness Acts Inclusively Demonstrates Initiative Entrepreneurial Mindset Continuous Learning Embraces Change Results-Oriented Analytical Thinking/Data Analysis Financial Excellence Communicates with Clarity

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