Job details
Job type full-time
Full job description
Beigene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionalsWhen considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancerCompany overview: beigene (nasdaq: bgne; hkex: 06160; sse: 688235) is a global, science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwideWith a broad portfolio of more than 40 clinical candidates, we are expediting development of our diverse pipeline of novel therapeutics through our own capabilities and collaborationsWe are committed to radically improving access to medicines for two billion more people by 2030Beigene has a growing global team of over 8,200 colleagues across five continentsFor more information, please visit www.beigene.com General description: the functional cra line manager provides resourcing, oversight, study assignment, training, and metrics review for assigned fsp cra staffCoaching and mentoring will be a shared responsibility with line manager of cro company cra is employed withMay provide performance management responsibilities for beigene staff the functional cra line manager ensures proper monitoring expectations in collaboration with ctoms; including but not limited to adherence to monitoring sops, gcp guidelines, country-specific regulations, and general quality and risk-based effectiveness the functional cra line manager may complete assessments visits for assigned staff as required and as contractedProactively seeks opportunities to lead and drive improvements to optimize effectiveness and efficiencies within the site management group as well as within the greater americas region essential functions of the job: the following functions may apply based on study and program requirements:
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.
Acts as the escalation point person for ctom(s) and study teams with cra related issues and concerns
Works with ctoms 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 and issues to 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
Supervisory responsibilities:
Supervision of cra staff
May supervise other roles as required within site management organization
Provides necessary training to cra staff and support site visits, as needed
Co-monitoring as necessary with cras, if needed, to ensure oversight and address site-related concerns
Assists with the identification of development opportunities for junior team members
Computer skills:
Efficient in microsoft word, excel, and outlook
Familiar with industry ctms and data management systems
Other qualifications:
Understands clinical trial processes with a thorough knowledge of ich and associated regulatory guidelines
2-3 years of management or oversight within pharmaceutical or cro industry
2-3 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
Education required: bs/ba in a relevant scientific discipline and minimum of 6 years of relevant clinical operations experience; 1 of those being management experience, and minimum of 4-5 years of monitoring experienceExperience in oncology global trials preferredTravel: up to 20 - 30% time competencies: ethics - treats people with respect; inspires the trust of others; works with integrity and ethically; upholds organizational valuesPlanning/organizing - prioritizes and plans work activities; uses time efficientlyCompletes administrative tasks correctly and on timeFollows instructions and responds to management directionCommunication - listens and gets clarification; responds well to questions; speaks clearly and persuasively in positive or negative situationsWrites clearly and informativelyAble to read and interpret written informationTeamwork - 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 succeedContributes to building a positive team spirit; shares expertise with othersAdaptability – able to adapt to changes in the work environmentManages competing demandsChanges approach or method to best fit the situationAble to deal with frequent change, delays, or unexpected eventsTechnical skills - assesses own strengths and development areas; pursues training and opportunities for growth; strives to continuously build knowledge and skills; shares expertise with othersDependability - 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 planQuality - demonstrates accuracy and thoroughness; looks for ways to improve and promote quality; applies feedback to improve performance; monitors own work to ensure qualityAnalytical - synthesizes complex or diverse information; collects and researches data; uses intuition and experience to complement dataProblem solving - identifies and resolves problems in a timely manner; gathers and analyzes information skillfullyWe are proud to be an equal opportunity employer and we value diversityBeigene 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 lawAll employment is decided on the basis of qualifications, merit, and business need.
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