CTMA Associate Line Manager
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<p>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.</p><p></p><p></p><div><div><p><span> </span><b><span>General Description:</span></b><span><span> </span></span></p><p></p></div><div><p><span><span>The role is a combination</span><span><span> </span>of line management and operational responsibilities, in different proportions</span><span>. In general, the balance is 50/50</span><span>,</span><span><span> </span>but variations may apply and<span> </span></span><span>are</span><span><span> </span>to be expected. </span></span><span> </span></p></div><div><ul><li><p><span><span>Line<span> </span></span><span>manage</span><span><span> </span>Trial Support staff. Responsibilities include planning, assigning, and directing work, assessing performance, and guiding<span> </span></span><span>the<span> </span></span><span>professional development of direct reports. </span></span></p></li></ul></div><div><ul><li><p><span><span>Participate in selection for hiring and allocation of resources to clinical research projects by assigning staff to clinical studies based on their experience and training. </span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Proactively seeks opportunities to support, contribute or lead improvements, implements best practices and shares lessons learned with team and other colleagues – various levels of involvement possible, depending on seniority in the role </span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Supports study teams with Clinical Operations tasks, and/or<span> </span></span><span>supports</span><span><span> </span>compilation and quality of the trial master file (TMF) </span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Demonstrates basic clinical operations knowledge and strong organizational skills </span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Adheres to ICH/GCP, local regulations, SOPs and contributes to the development and/or review of Clinical Operations Work Instructions and SOPs </span></span><span> </span></p></li></ul></div><div><p><span> </span></p></div></div><div><div><p><b><span>Essential Functions of the Job: </span></b><span> </span></p></div><div><p><b><span>Line<span> </span></span><span>Management:</span></b><span> </span></p></div><div><ul><li><p><span><span>Conduct regular 1:1s with up to 10 direct reports (</span><span>may be</span><span><span> </span>a group of<span> </span></span><span>Be</span><span>One</span><span><span> </span>internal CT</span><span>M</span><span>As and FSP CT</span><span>M</span><span>As) to assess workload, provide feedback, track goals,<span> </span></span><span>and<span> </span></span><span>development. For the FSP CT</span><span>M</span><span>As, meet regularly with FSP line manager(s) to ensure<span> </span></span><span>timely</span><span><span> </span>feedback. </span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Conduct quarterly, mid-year, and year-end performance reviews </span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Interview and onboard new hires; ensure ongoing training compliance.</span><span> </span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Ensures that staff are meeting defined workload and quality metrics through regular review and reporting of findings as outlined by clinical operations management. </span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Demonstrates mastery of skills<span> </span></span><span>required</span><span><span> </span>to support clinical<span> </span></span><span>trials.</span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Understands<span> </span></span><span>the<span> </span></span><span>importance of delegated activities and how they fit within drug development process </span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Manage and<span> </span></span><span>maintain</span><span><span> </span>CT</span><span>M</span><span>A resourcing tools </span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Constantly strive for operating excellence, question<span> </span></span><span>the status quo,</span><span><span> </span>and promote innovation. </span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Contributes to Clinical Operations strategy and performance against key metrics,<span> </span></span><span>identifying</span><span><span> </span>areas of<span> </span></span><span>improvement</span><span><span> </span>and<span> </span></span><span>proposing</span><span><span> </span>solutions - various levels of involvement possible, depending on seniority in the role </span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Support, contribute or lead the development of local/global workstreams - various levels of involvement possible, depending on seniority in the role. </span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Participate in and help<span> </span></span><span>facilitate</span><span><span> </span>CT</span><span>M</span><span>A Forum discussions </span></span><span> </span></p></li></ul></div><div><p><span><span> </span></span><span> </span></p></div><div><p><b><span>Clinical Operations support to study teams:</span></b><span><span> </span></span><span> </span></p></div><div><ul><li><p><span><span>Provides support to cross-functional clinical study teams from start-up through close-out: </span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Assists</span><span><span> </span>in development of clinical trial documents, manuals,<span> </span></span><span>and<span> </span></span><span>trackers (may support informed consent development and version tracking) </span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Preparation and documentation of internal and external meetings by preparing agendas and minutes </span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Maintaining</span><span><span> </span>clinical operations tracking tools (</span><span>e.g.</span><span><span> </span>CTMS, EDC, IRT) as instructed by the study lead </span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Contributes to<span> </span></span><span>the<span> </span></span><span>setup, maintenance and close out of TMF </span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Administrative: business and department office administration support if<span> </span></span><span>required</span><span> </span></span><span> </span></p></li></ul></div><div><p><span><span> </span></span><span> </span></p></div></div><div><div><p><b><span>Education Required: </span></b><span><span> </span></span><span> </span></p><p></p></div><div><ul><li><span><span>Bachelor’s degree or higher in a scientific or healthcare discipline, and advanced degrees preferred.</span><span> </span></span><span> </span></li></ul></div><div><ul><li><span><span>Experience in Oncology is highly recommended. </span></span><span> </span></li></ul></div></div><div><div><p><b><span>Computer Skills:</span></b><span><span> </span></span><span> </span></p></div><div><ul><li><p><span><span>Efficient in Microsoft Word, Excel, MS Project, MS<span> </span></span><span>PowerPoint</span><span><span> </span>and Outlook</span><span>.</span></span><span> </span></p></li></ul><p></p></div><div><p><b><span>Other<span> </span></span><span>Qualifications:</span></b><span> </span></p></div><div><ul><li><p><span><span>Minimum </span><span>3</span><span> years of industry experience in the pharmaceutical</span><span>,</span><span><span> </span>CRO</span><span>,</span><span><span> </span>or relevant field </span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Thorough understanding of the drug development process, including expert knowledge of international standards (ICH-GCP) and health authority requirements </span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Prior clinical trial experience, including experience in a <span style="overflow-wrap: break-word; display: inline; text-decoration: inherit; hyphens: auto;">management/leadership</span> capacity or<span> </span></span><span>demonstrating</span><span><span> </span>prior ownership of <span style="overflow-wrap: break-word; display: inline; text-decoration: inherit; hyphens: auto;">management/leadership-type</span> tasks</span></span><span><span> </span></span><span><span> </span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Ability to work independently and effectively handle multiple priorities in a fast-paced environment </span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Excellent interpersonal skills, strong organizational<span> </span></span><span>skills</span><span><span> </span>and effective written and verbal communication skills across all levels within an organization </span></span><span> </span></p></li></ul></div><div><ul></ul></div><div><p><b><span>Travel</span></b><span><span>: up to15% </span></span><span> </span></p></div><div><p><span> </span></p></div><div><p><span> </span></p></div></div><p style="text-align:inherit"></p><p style="text-align:inherit"></p><div><div><div><div>Salary Range France: 61,700.00 EUR - 77,100.00 EUR</div></div></div></div><p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:left"><u><span>Global Competencies</span></u></p><p style="text-align:left">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.</p><ul><li>Fosters Teamwork</li><li>Provides and Solicits Honest and Actionable Feedback</li><li>Self-Awareness</li><li>Acts Inclusively</li><li>Demonstrates Initiative</li><li>Entrepreneurial Mindset</li><li>Continuous Learning</li><li>Embraces Change</li><li>Results-Oriented</li><li>Analytical Thinking/Data Analysis</li><li>Financial Excellence</li><li>Communicates with Clarity</li></ul><p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:left">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.</p><p style="text-align:inherit"></p><p style="text-align:inherit"></p>