Senior Manager Risk Based Monitoring, Trial Strategy and Delivery (Maternity Cover with Potential for Permanent Hire)

<p>At Genmab, we’re committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in science, we believe that being proudly unique, determined to be our best, and authentic is essential to fulfilling our purpose.</p><p></p><p>The Senior Manager Risk Based Monitoring, Trial Strategy and Delivery will be responsible for supporting the Clinical Trial Teams (CTTs) in timely planning and execution of Risk Based Quality Management (RBQM) deliverables in accordance with standard operating procedures (SOPs), policies and practices from study start-up, during conduct to closure.</p><p></p><p>This is a Maternity Cover position with Potential for Permanent Hire.</p><p></p><p>Requirements</p><p>For this role we need you, who have previous experience in working with RBQM adoption, including identification of critical data and process, associated risks and monitoring strategies. You will have a key role in bringing together all the relevant skill areas involved in monitoring activities. You are motivated to work in a company culture with an entrepreneurial spirit along with highly competent colleagues.</p><p></p><p>You recognize yourself in following descriptions:</p><ul><li><p>You have a minimum of 4 years of experience from biotech or pharma companies</p></li><li><p> You have experience in planning and executing Risk Based Quality Management (RBQM) activities in collaboration with Clinical Trial Team (CTT)</p></li><li><p>You have been guiding CTT in identification of critical data and processes, performing risk assessment and mitigation workshops, defining appropriate monitoring strategies, and developing monitoring plans</p></li><li><p>You have been performing centralized monitoring of Key Risk Indicators to identify trends and communicate the surfacing signals to CTT</p></li><li><p>You have experience in collaboration with clinical CRO in relation to planning and overseeing monitoring strategies</p></li><li><p>You understand the processes within trial management or data management</p></li><li><p>You either have a good understanding of oncology or a strong willingness to learn about oncology enabling you to identify clinical data and processes</p></li><li><p>You thrive with planning and organizational tasks</p></li><li><p>You work in an analytical manner and can interpret and present data</p></li><li><p>You understand clinical development/trial conduct, including GCP, ICH E6 (R2), ICH E8 (R1)</p></li><li><p>You have good Communication skills and can communicate scientific communication in a clear and concise manner</p></li><li><p>You are comfortable solving problems and making decisions</p></li><li><p>You are detail oriented and have a quality mindset</p></li><li><p>You enjoy working with process development</p></li></ul><p><br/>Responsibilities</p><ul><li><p>Support the CTT during development of trial protocol and study set-up in decision on which data and processes are critical and whether any of the associated risks can be mitigated through quality by design</p></li><li><p>Drive the discussions within CTT to identify critical data and process, associated risks and monitoring strategies including monitoring triggers/thresholds (development of Risk Assessment and Monitoring Plan)</p></li><li><p>Have a key role in bringing together all the relevant skill areas involved in monitoring activities</p></li><li><p>Monitor Key Risk Indicators (KRIs), Parameters with Quality Tolerance Limits (PQTLs) and other trial specific data analytics tailored to the individual protocol according to the trial Risk Assessment and Mitigation Plan</p></li><li><p>Review and approve trial specific RBQM set-up documentation for adherence with RBQM framework</p></li><li><p>Attend study team meetings as needed</p></li><li><p>Support the development and use of study management plans and/or risk-based monitoring specific tools and templates and/or other study specific plans to evaluate the quality and integrity of the study</p></li><li><p>Support presentations and training of internal and external team members</p></li><li><p>Ensure that knowledge from one trial/program is applied in other trials/programs and offer assistance to team members to create an effective and supportive working environment</p></li><li><p>Ensure lessons learned are documented and shared with the rest of the organization to facilitate cross-study and cross-organization learning</p></li><li><p>Proactively manage progress of agreed RBQM activities with selected RBM vendor</p></li><li><p>Superuser of RBQM functionality</p></li><li><p>Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes</p></li><li><p>Facilitate the adoption and unders