Global Clinical Compliance Lead

General Description:

• The Global Clinical Compliance Lead (gCCL) is responsible for implementing the global clinical compliance and inspection management strategy across BeiGene clinical programs at study level, as assigned. The gCCL provides compliance and quality support to BeiGene GCO study teams for the assigned programs / studies and ensures that appropriate GCO study conduct, inspection readiness and overall compliance with applicable regulatory requirements are systematically maintained. The gCCL supports timely identification of non-compliance, ensures appropriate escalation of quality issues, potential misconduct, and significant deviations to relevant stakeholders, and supports the study teams in managing the identified issues. The gCCL supports tracking and trending of non-compliance, issues, and observations to help identify issues and risks across BeiGene study programs and processes. The CCL supports Global and Regional Clinical Compliance in the development and implementation of GCP inspection readiness activities and programs.

Essential Functions of the job:

• Provides oversight and support to BeiGene study teams in risk and issue identification, risk and issue management and inspection readiness, as assigned, to ensure that BeiGene studies are conducted in compliance with applicable regulations and BeiGene processes and procedures and are inspection ready at all times.

• Proactively identifies issues and risks in BeiGene clinical trials, manages them by ensuring appropriate investigation and preparation of corrective and preventive action plans, and escalates them as necessary.

• Enhances, maintains, and updates the GCO inspection readiness “game-plan” to ensure GCO operates with an always inspection ready mindset.

• Establishes, leads, and supports analysis of GCO processes for gaps, process improvement and risk mitigation opportunities and leads the efforts in preparing a strategy for correction, as assigned.

• Actively assists with regulatory authority inspections, including document review, drafting, or reviewing inspection responses, following up on timely response implementation and reviewing evidence submitted in support of response implementation, as assigned.

• Creates and presents regular status updates on various aspects of GCC activities, as assigned.

• Partners with Quality Assurance and GCO teams to establish roles and responsibilities for issue management, ensuring consistency across GCO.

• Develops and implements or supports development and implementation effective metrics and monitoring programs to assure constant vigilance with respect to GCC activities.

• Creates and delivers education programs in the area of clinical compliance, as assigned.

• Assures that effective communication tools, including structured meetings, are established and maintained.

• Maintains up to date all relevant systems and tools.

Education Required:

• Bachelor’s degree (BS/BA or equivalent) or higher in a scientific, medical or healthcare discipline* with minimum of 3-5 years of experience in pharmaceutical or biotechnology drug development.

• Experience in global oncology trials preferred.

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

Competencies:

Ethics - Treats people with respect; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.

Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently. Completes administrative tasks correctly and on time. Follows instructions and responds to management direction.

Communication - Listens and gets clarification; Responds well to questions; Speaks clearly and persuasively in positive or negative situations. Writes clearly and informatively. Able to read and interpret written information.

Teamwork - Balances team and individual responsibilities; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Supports everyone's efforts to succeed.

Contributes to building a positive team spirit; Shares expertise with others.

Adaptability – Able to adapt to changes in the work environment. Manages competing demands. Changes approach or method to best fit the situation. Able to deal with frequent change, delays, or unexpected events.

Technical Skills - Assesses own strengths and development areas; Pursues training and opportunities for growth; Strives to continuously build knowledge and skills; Shares expertise with others.

Dependability - Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan.

Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.

Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data.

Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully.

Project Management - Communicates changes and progress; Completes projects on time and budget.