Senior Manager Risk Based Monitoring, Trial Strategy and Delivery - Utrecht, Nederland - Genmab

Beschrijving

The Role

The Senior Manager Risk Based Monitoring, Trial Strategy and Delivery will be responsible for supporting the CTTs in timely planning and execution of Risk Based Quality Management deliverables in accordance with standard operating procedures (SOPs), policies and practices from study start-up, during conduct to closure.

The Senior Manager Risk Based Monitoring will join the RBQM team, Trial Strategy and Delivery and support the CTTs with development of Risk Assessment and Mitigation Plan (RAMP), identification of critical to quality factors, Parameters with Quality Tolerance Limits (PQTLs), Key Risk Indicators (KRIs), thresholds for action and monitoring tactics, as well as identification of de-risking initiatives and mitigation activities.

The Senior Manager Risk Based Monitoring will closely collaborate with relevant RBM vendor to ensure proper implementation of applicable RBQM model selected for the study according to agreed roles and responsibilities between Genmab and RBM vendor.

Responsibilities

As a Senior Manager Risk Based Monitoring you will drive and/or independently perform:

• 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
• Drive the discussions within CTT to identify critical data and process, associated risks and monitoring strategies including monitoring triggers/thresholds
• Have a key role in bringing together all the relevant skill areas involved in monitoring activities
• 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
• Review and approve trial specific RBQM set-up documentation for adherence with RBQM framework
• Attend study team meetings as needed
• 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
• Support presentations and training of internal and external team members
• 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
• Ensure lessons learned are documented and shared with the rest of the organization to facilitate cross-study and cross-organization learning
• Proactively manage progress of agreed RBQM activities with selected RBM vendor
• Superuser of RBQM functionality
• Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes
• Facilitate the adoption and understanding of RBQM across project teams
• Lead/support implementation of RBQM and continuous training to Genmab employees and vendors as applicable
• Lead/support working groups in initiatives for RBQM and central monitoring or related process/system improvement
• Support the update and maintenance of a CD/P risk library, incl. PQTLs/KRIs

Requirements

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. Genmab experiences rapid growth and we are in the starting phase of building the future Risk Based Quality Management. Hence, it is imperative that you thrive in a changing environment where you have great opportunities to influence the path and outcome.

You recognize yourself in following descriptions:

• You have a minimum of 4 years of experience from biotech or pharma companies
• You have experience in planning and executing Risk Based Quality Management (RBQM) activities in collaboration with Clinical Trial Team (CTT)
• 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
• You have been performing centralized monitoring of Key Risk Indicators to identify trends and communicate the surfacing signals to CTT
• You have experience in collaboration with clinical CRO in relation to planning and overseeing monitoring strategies
• You understand the processes within trial management or data management
• You either have a good understanding of oncology or a strong willingness to learn about oncology enabling you to identify clinical data and processes
• You thrive with planning and organizational tasks
• You work in an analytical manner and can interpret and present data
• You understand clinical development/trial conduct, including GCP, ICH E6 (R2), ICH E8 (R1)
• You have good Communication skills and can communicate scientific communication in a clear and concise manner
• You are comfortable solving problems and making decisions
• You are detail oriented and have a quality mindset
• You enjoy working with process development

For US based candidates, the proposed salary band for this position is as follows:

The actual salary offer will carefully consider a wide range of factors, including your skills, qualifications, experience, and location. Also, certain positions are eligible for additional forms of compensation, such as bonuses.

About You

• You are passionate about our purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatment
• You bring rigor and excellence to all that you do. You are a fierce believer in our rooted-in-science approach to problem-solving
• You are a generous collaborator who can work in teams with diverse backgrounds
• You are determined to do and be your best and take pride in enabling the best work of others on the team
• You are not afraid to grapple with the unknown and be innovative
• You have experience working in a fast-growing, dynamic company (or a strong desire to)
• You work hard and are not afraid to have a little fun while you do so

Locations

Genmab leverages the effectiveness of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are designed as open, community-based spaces that work to connect employees while being immersed in our state-of-the-art laboratories. Whether you're in one of our collaboratively designed office spaces or working remotely, we thrive on connecting with each other to innovate.