BeOne 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.
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Language Requirement: Fluent English is Required
Preferred Experience: Pharmaceutical/Biotech Industry
Location: Brazil Remote (close to Sao Paulo preferrable)
Please note this position can be filled at either the Manager or Senior Manager level depending upon experience.
General Description:
The Manager, Regional Clinical Compliance:
- Is responsible for implementing Global Clinical Compliance (GCC) and Inspection Management strategy across BeOne Clinical activities at regional, country, study and/or site levels.
- Independent from the Clinical Study Team (CST), provides compliance oversight as well as quality 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, share lessons learned, lead and drive improvements to optimize effectiveness and efficiency within the Global and Regional Clinical Compliance team, as well as within the Global and Regional Clinical Operations team.
- Supports timely identification of non-compliance issues and quality events, ensure appropriate escalation of those issues and events as well as potential misconduct or potential Serious Breach to relevant stakeholders.
- Tracks and trends non-compliance issues, quality events, and any other relevant observations identified during Site Compliance Visits (SCV), to help identify issues and risks across BeOne study programs and processes.
- 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 and conduct at a study and site level, and clinical operations processes.
- Demonstrates BeOne clinical operations knowledge, organizational skills, project management and leadership competencies.
- Supports inspection readiness, preparation, hosting, response management and further lesson-learned development, as assigned.
Essential Functions:
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- Provides GCP compliance guidance and support to BeOne CST and other GCO stakeholders for the assigned portfolio of studies in the applicable regulatory requirement(s) and SOPs.
- Supports remote compliance review targeting business-critical clinical studies to detect potential non-compliance risk, issues and assess the inspection steady status of identified studies.
- Performs periodic risk evaluations for assigned studies to identify investigator sites showing signals of non-compliance by reviewing and comparing existing study data and collaborating with relevant stakeholders, e.g. regional & country GCO, Study RCC counterparts, g/rCSMs, CRAs and relevant line managers.
- Plans and conducts SCVs at identified investigator sites to observe and assess the quality of the monitoring and study conduct at sites, and proactively identify compliance issues at site, study, and/or monitoring level.
- Evaluates the quality and integrity of site practices, escalating quality and/or GCP non-compliance issues to investigators, site staff and internal GCO team as appropriate.
- Assesses classification and severity of on-site and remote compliance observations identified per appropriate SOPs and shares SCV outcome with relevant BeOne stakeholders.
- Completes on-site and remote compliance visit reports within BeOne-specified timelines per SOP.
- Follows up with action owners and key stakeholders, such as the CRA, CRA Line Manager, Country / Functional representative, and g/rCSM to support the timely resolution of reported on-site and remote compliance visit observations and ensure appropriate corrective and preventive action plans (CAPA) are implemented to address observations and mitigate related risks.
- Ensures that action owners are clearly identified for each on-site and remote compliance visit observation and CAPA developed within timelines as specified in relevant BeOne SOPs.
- Ensures that all relevant GCC & RCC systems and tools are used to schedule and document on-site and remote compliance visits.
- Conducts peer review of site compliance visit reports.
- Stays abreast of new and revised government, industry and company regulations, trends and interpretations by participating in trainings, conferences, workshops and discussion groups as appropriate
- Supports trend analysis using on-site and remote compliance visit observations and supports compliance dashboard development and maintenance, supports ongoing risk assessment to ensure quality standards are being met and addresses concerns associated with study delivery at sites.
- Provides constructive feedback on CRAs and other team members performance to their line managers to support performance review as applicable.
- Provides feedback on investigator site performance for future study feasibility purposes.
Manager Minimum Requirements – Education and Experience:
- Bachelor’s degree (BS/BA or equivalent) in a scientific, medical or healthcare discipline* with minimum of 5 years of progressive experience in clinical operations roles.
- Minimum 2 years’ experience in a GCP compliance or equivalent role (i.e. quality) is preferred.
- Minimum 4 years’ experience in a lead monitoring or trial oversight role.
- Experience in oncology global trials is preferred.
*exceptions may be made for candidates with equivalent appropriate Clinical Operations experience.
Senior Manager Minimum Requirements – Education and Experience:
- Bachelor’s degree (BS/BA or equivalent) in a scientific, medical or healthcare discipline* with minimum of 7 years of progressive experience in clinical operations roles.
- Minimum 2 years’ experience in a GCP compliance or equivalent role (i.e. quality) is preferred.
- Minimum 4 years’ experience in a lead monitoring or trial oversight role.
- Experience in oncology global trials is preferred.
*exceptions may be made for candidates with equivalent appropriate Clinical Operations experience.
Other Experience:
- Understanding of clinical trial processes with a thorough knowledge of ICH-GCP and associated regulatory guidelines
- Analytical and problem-solving skills
- Organizational, project management and leadership skills
- Excellent English written and verbal communication and interpersonal skills
- Excellent organizational skills and 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: May coach or mentor junior team members.
Travel: up to 50-75% travel
Computer Skills: PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint)
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Global Competencies
When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity, and Collaborative Spirit, 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
We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.