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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 Sr CTOM collaborates on the resource strategy for the team, provides management oversight and mentoring for CTOMs and has accountability for direct report’s portfolio of studies.The Sr CTOM is a strategic partner to the Clinical Study Team (CST) to plan and execute clinical trials and perform study site oversight activities to ensure data quality and patient safety in accordance with ICH guidelines and GCP, local regulations, and applicable SOPs for assigned portfolio of studies.The Sr CTOM identifies risk strategies per appropriate SOPs for their assigned portfolio and supports staff on appropriate risk identification and mitigation. Conducts Site oversight visits to observe and assess quality of the monitoring. Where issues and risks are identified, the Sr CTOM collaborates with the CRA(s) and CRA Line Management to ensure appropriate corrective and preventive actions are in placeThe Sr. CTOM is responsible for strategy regarding site and country intelligence in assigned regions/countries, developing strong relationships with sites, networks and advocacy groups. Sr CTOM determines appropriate plans for direct reports to support this effortProactively 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:Responsible for management and development of direct report staff (junior staff and CTOMs)
Responsible for engagement strategy in assigned country/region(s)
Responsible for managing assigned portfolio of studies by performing oversight and engagement visits
Responsible for site relationship and quality of site activities as they relate to BeiGene protocols.
Responsible for oversight of monitoring quality, protocol execution, and patient safety
Responsible for developing outreach plans for continued engagement with sites, networks and advocacy groups.
Acts as the escalation point person for CTOM(s) and study teams with site related issues andconcerns
Is a primary liaison with regard to Risk identification and mitigation throughout study lifecycle
Conducts and reports Quality Oversight Visits (QOV) aka Site Oversight Visits (SOVs) to proactively identify issues on a study, site, and CRA level, as well as ensuring resolution of issues identified
Completes QOV/SOV reportswithin BeiGene-specified timelines
Conducts Investigator Engagement contact report (IEC) to proactively identify new potential investigators for BeiGene and inform current investigators of potential new work.
Completes IEC reportswithin BeiGene-specified timelines
Documents monitoring oversight activities appropriately following ICH-GCP and BeiGenestandards
Assists with investigator/siteidentification
In partnership with CST, provides protocol and related study training to assignedsites
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 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, asrequired
Establishes regular lines of communication with sites and reports site progress and issues to ClinicalOperations
Attends disease indication project specific training and general CTOM training, asrequired
Provide support for site audits/inspections, as needed, and follow-through with audit/inspection findings to resolution
Evaluatesthequalityandintegrityofsitepractices, escalatingqualityand/orGCPissueswithinvestigatorsand internal team asappropriate
Collaborates on or reviews study-specific Project Management Plans
Supervisory Responsibilities:Provides oversight management for assigned portfolio of studies and those of direct report staff
Provides management, mentoring and oversight of junior staff and Clinical Trial Oversight Managers
Provides necessary training to CTOMs and support site visits, asneeded
Develops training plan(s) for CTOMs and related teammembers
Co-monitoring with BeiGene CTOMs, as well as CRO CRAs, if needed, to ensure oversight and address site-relatedconcerns
Assists with the identification of development opportunities for junior teammembers
Provides necessary training to CST clinical staff and support site visits, asneeded
Computer Skills: Efficient in Microsoft Word, Excel, and OutlookOther Qualifications:Understands clinical trial processes with a thorough knowledge of ICH and associated regulatoryguidelines
Minimum of 8-9 years working in Clinical Operations
Combination of 3-5 years of trial management or personnel oversight within pharmaceutical or CRO Industry and 4-5 years of (CRA) monitoring experience in the pharmaceutical or CROIndustry
Excellent communication and interpersonalskills
Excellent organizational skills and ability to prioritize andmulti-task
Education Required:BS/BA in a relevant scientific discipline such as and minimum of 8-9 years of relevant Clinical Operationsexperience; 3-5 of those being management experience (trial and/or personnel) andminimumof4-5years of clinical monitoring experience
Experience in oncology global trialspreferred
Travel: up to 50-60% timeCompetencies: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.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.
