• Job Description

  Req#: R18503

  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 CTOM plans and executes clinical trial and monitoring oversight activities to ensure data quality and patient safety in accordance to ICH guidelines and GCP, local regulations, and applicable SOPs.

  The CTOM is responsible for performing quality study oversight site visits and collaborating closely with the clinical operations team to ensure that required quality standards are maintained. The CTOM is responsible for identifying CRA performance issues and ensuring appropriate corrective and preventative actions are in place.

  Essential Functions of the job:

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

  • Responsible for site and monitoring quality, protocol execution, and patient safety
  • Mentors junior staff
  • Acts as the escalation point person for CTOM(s) and study teams with site related issues and concerns
  • Reviews RFPs and SOWs to ensure adequate CRO monitoring and relevant CRO procedures are correctly reflected
  • Conducts monitoring (pre-study, initiation, routine monitoring and closeout visit) per monitoring plan and applicable SOPs, as needed
  • Conducts co-monitoring visits, as needed
  • Conducts and reports Study Oversight Visits (SOV) to proactively identify issues on a study, site, and CRA level, as well as ensuring resolution of issues identified
  • Completes monitoring visit/SOV reports within BeiGene-specified timelines
  • Documents monitoring oversight activities appropriately following ICH-GCP and BeiGene standards
  • Assists with investigator/site identification
  • Provides protocol and related study training to assigned sites
  • Manages site performance by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution
  • Collaborates with clinical operations team and clinical study sites to ensure timely delivery of study milestones (i.e., study startup, recruitment, database analyses, closeout, etc.)
  • Supports the clinical operations team to manage the clinical study sites, as required
  • Establishes regular lines of communication with sites and reports site progress and issues to Clinical Operations
  • Authors or reviews study-specific Site Oversight Plans
  • Assists in review of monitoring visit reports, as needed
  • Attends disease indication project specific training and general CTOM training, as required
  • Provide support for site audits/inspections, as needed, and follow-through with audit/inspection findings to resolution
  • Evaluates the quality and integrity of site practices, escalating quality and/or GCP issues with investigators and internal team as appropriate
  • Conducts site engagement visits as needed
  • Attends and presents at investigator meeting and site booster visits, as required, to ensure adequate training of CRO monitoring team and study sites

  Supervisory Responsibilities:

  • Provides mentoring and oversight of junior staff, CRAs and Clinical Trial Oversight Managers
  • Provides necessary training to CTOMs, CRAs and support site visits, as needed
  • Develops training plan(s) for CTOMs, CRAs and related team members
  • Co-monitoring with BeiGene CTOMs and CRAs, COMs as well as CRO CRAs, if needed, to ensure oversight and address site-related concerns
  • Assists with the identification of development opportunities for junior team members

  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.

  Computer Skills: Efficient in Microsoft Word, Excel, and Outlook

  Other Qualifications:

  • Understands clinical trial processes with a thorough knowledge of ICH and associated regulatory guidelines
  • 6 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
  • Fluent in English (writing and speaking)

  Travel: up to 60-70% time

  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

  Salary Range: $111,500.00 - $151,500.00 annually

  BeiGene is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeiGene Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.

  We are proud to be an equal opportunity employer and we value diversity. BeiGene 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.

• About the company

  BeiGene is a biotechnology company that specializes in the development of drugs for cancer treatment.

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