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(senior) Manager Risk Based Monitoring, Trial Strategy And Delivery, Copenhagen

Denmark, Denmark, Copenhagen
Udgivet 2024-02-05
Udløber 2024-03-05
ID #2019644542
Free
(senior) Manager Risk Based Monitoring, Trial Strategy And Delivery, Copenhagen
Denmark, Denmark, Copenhagen,
Udgivet February 5, 2024

Beskrivelse

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.

The role The (Senior) Manager RBM will be responsible for supporting the CTTs in timely planning and execution of RBQM deliverables in accordance with standard operating procedures (SOPs), policies and practices from study start-up, during conduct to closure.

The (Senior) Manager RBM will join the RBQM team, Trial Strategy and Delivery and support the CTTs with Risk Assessment Management 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 RBM 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 RBM you will drive and/or independently perform: For CTT support and across Genmab portfolio: Review protocols to identify critical data and process (CD/P), safety, and data integrity risks related to protocol execution.

Drive and oversee the set-up and implementation of RBQM activities.

Supporting CTTs with identification of critical to quality factors, associated risks and monitoring strategies.

Review and approve trial specific RBQM set-up documentation for adherence with RBQM framework.

 Support project management team to develop monitoring strategy including monitoring triggers/thresholds.

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 the CTTs in describing the risk strategies in risk management plans as well as the monitoring tactics in the monitoring plans.

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 RBM 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 has previous experience working with RBQM or has a good understanding of RBQM.

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.

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.

Joboplysninger

Jobtype: Fuld tid
Kontrakttype: Permanent
Løn type: Månedlige
Beskæftigelse: (senior) manager risk based monitoring, trial strategy and delivery

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