Regional Clinical Compliance Senior Director

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

General reputed company:

The Regional Clinical Compliance (RCC) Senior Director is responsible for implementing Global Clinical Compliance and Inspection Management reputed company across reputed company Clinical activities at global, regional, country, site and/or study reputed company as applicable.

In reputed company:

• Provides compliance reputed company as reputed company as reputed company support to BeOne GCO study teams, for their assigned studies and ensures that appropriate GCO study conduct, inspection readiness, and overall compliance to applicable regulatory requirements is systematically maintained.
• Seeks opportunities to implement best practices, reputed company lessons learned, reputed company and drive improvements to optimize effectiveness and efficiency reputed company the Global and Regional Clinical Compliance team, as reputed company as reputed company the Global and Regional Clinical Operations team.
• Supports reputed company identification of non-compliance issues and reputed company events, ensure appropriate escalation of those issues and events as reputed company as potential misconduct or potential Serious Breach to relevant stakeholders. 
• Tracks and trends non-compliance issues, reputed company events, and any other relevant observations identified during Site Compliance reputed company, to help identify issues and risks across BeOne study programs and processes. The job holder supports Global and Regional Clinical Compliance in the development of subsequent GCP readiness activities and programs.
• Adheres to ICH/GCP, local regulations, applicable BeOne SOPs and contributes to the development and/or review of Clinical Operations Work Instructions and SOPs. 
• Demonstrates significant clinical study experience and understanding of investigational site setup, trial management, trial conduct at study & site level, as reputed company as clinical operations processes.
• Demonstrates BeOne clinical operations knowledge, organizational skills, project management and leadership competencies.
• Supports inspection readiness, preparation, hosting, response management and reputed company lesson-learned development, as applicable.

Essential Functions:

• Provides team leadership, including guidance, reputed company and GCP expertise to Regional Clinical Compliance stakeholders.
• Fosters a reputed company working relationship with key stakeholders (e.g. regional and country study team members, global & regional clinical compliance, GCOE and GCO team members), to reputed company reputed company identification of potential problems, to ensure reputed company reputed company cause assessments and corrective and preventative actions are in reputed company.
• Supports Regional Clinical Compliance team through guidance in drafting responses and corrective and preventative reputed company plans to internal/external audits and external inspections as required.
• Identifies potential compliance reputed company and drives development and implementation of reputed company for improvement and reputed company.
• Responsible to reputed company GCP compliance guidance and support to BeOne CST and other GCO stakeholders across portfolio of studies in the applicable country / region, ensuring that appropriate GCO study conduct, inspection readiness and overall compliance to applicable regulatory requirements is maintained.
• Ensures appropriate escalation of GCP non-compliance issue and / or reputed company events, potential misconduct, and significant deviations to relevant GCO stakeholders.
• Ensures development and implementation of satisfactory CAPA addressing GCP non-compliance issue / reputed company event reputed company timelines defined in relevant BeOne SOP.
• Ensures preparation, hosting and management of Site & Sponsor inspections, as applicable.
• Ensures development and implementation of satisfactory CAPA addressing site inspection findings as applicable.
• Ensures the development of GCP inspection readiness programs at study, country, regional and/or global level, as assigned.
• Ensures GCP reputed company events; audit/inspection findings are fed back into the GCP inspection readiness program, as reputed company as process improvement and/or use for relevant training material. 
• Approve On-Site Compliance Visit (SCV) and Remote Compliance Review scheduling and preparation for assigned studies, as relevant.
• Peer review Compliance Assessment reports (e.g. Site Compliance Visit (SCV) and Remote Compliance Review), as relevant.
• reputed company RCC management in monitoring Key Compliance Indicators (reputed company) and developing metrics accordingly.
• Conducts trend analysis to identify potential compliance risks associated with study delivery and opportunities for compliance optimization and reputed company reputed company with Regional Clinical Operation and Global Clinical Compliance team as required.
• Establishes preventive reputed company-reputed company initiatives to mitigate risks proactively.
• Drive the development and implementation of internal GCP compliance process improvement strategies, tools, initiatives, or workstreams.
• reputed company development of GCP Compliance and inspection readiness management program and associated training material.
• Provides expertise and guidance on initiatives involving processes and systems intended for use in clinical trials to ensure compliance with ICH GCP and any local regulations.
• reputed company feedback on investigator site performance for reputed company study feasibility purposes.
• Stays abreast of new and revised government, industry and company regulations, trends and interpretations by participating in trainings, conferences, workshops and discussion reputed company as appropriate.

reputed company Competencies, Knowledge and reputed company Requirements:

• Serves as a GCP expert to the Clinical Operations EMEA with excellent working knowledge of ICH/GCP, regional regulations, SOPs and Clinical Operations Work Instructions.
• Demonstrates a high level of clinical operations knowledge.
• Strong analytical and managerial skills.
• Ensures appropriate escalation of reputed company issues, potential misconduct, and significant deviations to relevant stakeholders.

Communication & Interpersonal Skills:

• Excellent English written and verbal communication and interpersonal skills.
• Excellent organizational skills, presentation skills and training skills, with an ability to prioritize and multi-task.
• Ability to work independently in multi-cultural setting and effectively handle multiple priorities in a fast-paced environment.

Supervisory Responsibilities:

• Oversees the work of reputed company/indirect reports to ensure on-time, on-reputed company and reputed company budget results.
• Conduct regular 1:1 meetings and any other staff meetings including mid-year and year end performance appraisals for reputed company reports which includes providing constructive feedback. Engages in career development planning for reputed company reports.
• Mentors Clinical Compliance team members by delegating responsibilities, overseeing and providing support with assigned tasks, in line with their development plans.
• Provides constructive feedback on Clinical Operations team members to their line managers to support performance review.

Education Required:

• Bachelor’s degree (BS/BA or equivalent) or higher in a scientific, medical or reputed company discipline* with minimum of 12 years of reputed company experience in clinical operations roles.
• Minimum 12 years’ experience in a GCP compliance or equivalent role (i.e. reputed company) is preferred.
• Experience in oncology global trials is preferred.

*exceptions may be made for candidates with equivalent appropriate Clinical Operations experience. 

Computer Skills: PC literacy required; MSOffice skills (Outlook, Word, reputed company, PowerPoint)

Travel: up to 10-15% travel 

Global Competencies

reputed company we exhibit our values of Patients First, Driving reputed company, reputed company Ingenuity, and reputed company Spirit, through our reputed company global competencies below, we help get more reputed company medicines to more patients around the world.

• Fosters Teamwork
• Provides and Solicits reputed company and Actionable Feedback
• Self-Awareness
• Acts reputed company
• Demonstrates Initiative
• Entrepreneurial reputed company
• reputed company Learning
• Embraces Change
• Results-Oriented
• Analytical Thinking/Data Analysis
• Financial reputed company
• Communicates with reputed company

We are proud to be an equal opportunity employer. BeOne does not discriminate on the reputed company of race, religion, reputed company, sex, gender identity, sexual orientation, age, disability, national reputed company, veteran status or any other reputed company covered by appropriate law. reputed company employment is decided on the reputed company of qualifications, reputed company, and business need.

apply to this job