Clinical Trial Oversight Manager
Employment Type: Full-Time
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.
The CTOM is a partner to their assigned Clinical Study Teams (CST) focusing on oversight of site monitoring activities to ensure data quality and patient safety in accordance with ICH guidelines and GCP, local regulations, and applicable SOPs.
The CTOM identifies risk strategies per appropriate SOPs for their assigned portfolio and conducts Site oversight visits to observe and assess quality of the monitoring. Where issues and risks are identified, the CTOM collaborates with the CRA(s) and CRA Line Management to ensure appropriate corrective and preventive actions are in place.
The CTOM also supports site and country intelligence in assigned regions/countries, developing strong relationships with sites, networks and advocacy groups.
Proactively 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 the assigned portfolio of studies, and performs oversight activities and engagement visits per applicable SOPs
* Is a primary liaison with regard to Risk identification and mitigation throughout study lifecycle
* 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
* May mentor or support CRAs on study specific challenges
* Acts as the escalation point person for study teams with issues and concerns related to monitoring quality and/or site performance
* 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 reports within BeiGene-specified timelines
* Conducts Investigator Engagement Contact report (IEC), within BeiGene-specified timelines, to proactively identify new potential investigators for BeiGene and inform current investigators of potential new work.
* Documents monitoring oversight activities appropriately following ICH-GCP and BeiGene standards
* Assists with investigator/site identification
* In partnership with CST, provides protocol and related study training to assigned sites
* 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.)
* Collaborates on or reviews study-specific Project Management Plans
* 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
* May conduct co-monitoring visits, as needed
* Provides oversight management for assigned portfolio of studies
* Provides mentoring/support to CRAs for study related topics
* Provides necessary training to CST clinical staff and support site visits, as needed
* Co-monitoring as necessary with CRO 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
BS/BA in a relevant scientific discipline and minimum of 6 years of relevant Clinical Operations experience; 1-2 of those being trial management experience, and minimum of 3-5 years of monitoring experience. Experience in oncology global trials preferred
* Understands clinical trial processes with a thorough knowledge of ICH and associated regulatory guidelines
* Minimum of 6 years working in Clinical Operations
* Combination of 1-2 years of trial management or oversight within pharmaceutical or CRO Industry and 3-5 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
Travel: up to 50-60% time
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
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, non-disqualifying physical or mental 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.