Genmab is focused on the creation and development of innovative and differentiated antibody products, with the aim of improving the lives of cancer patients.
Genmab is looking for a highly motivated and experienced J-Review Clinical Systems Lead, with a minimum 7-10 years of experience from the Pharmaceutical/Biotech industry, to join Clinical Data Management within Clinical Operations. The J-Review Clinical Systems Lead is responsible for implementing, growing and maintaining the J-Review system to support data review and cleaning activities for clinical trials. This is a new position with high influence on the development of effective data review and cleaning tools and strategies.
In the role of J-Review Clinical Systems Lead, the employee will be responsible for supporting Data Management, Medical and other functional areas within R&D with the implementation and operation of J-Review Cloud for clinical data oversight and data cleaning activities and solutions. This encompasses the oversight of the end-to-end implementation of the J-Review application including object specification, management of daily operations, process development, training oversight and end-user adoption. The J-Review Clinical Systems Lead will act as the operational point of contact for the J-Review application and will ensure the development of data review and cleaning tools that optimally support the end-user requirements. The employee will chair a J-Review Core Team and interface with data review subject matter experts, driving the implementation and oversight of the application. The J-Review Clinical Systems Lead will coordinate with Integrated Clinical Systems and the IT organization regarding system hosting and maintenance to support daily operation of the application.
Further, the Associate Director, Data Management will support the development and optimization of processes and tools to enable success of the Clinical Operations department.
In this position, you will be reporting to the Head of Clinical Data Management. The J-Review Clinical Systems Lead will work closely with key stakeholders to ensure the implementation, growth and maintenance of the J-Review application to support successful clinical trial conduct. The key responsibilities include, but are not limited to:
Serving as the subject matter expert in data review and cleaning capabilities and functionalities of the J-Review application.
Facilitate business requirements, collect needs, assess and propose solutions, including creation of object specifications.
Collaborate with end-users to determine the best solutions to fulfill business needs within the J-Review application.
Develop new and innovative J-Review objects that are fit-for-purpose, deliver high business value and maximize data reviewer effectiveness.
Work collaboratively with IT to develop and support processes to maintain and administer the J-Review system (user access administration, change control, etc.)
Manage the roll-out of the J-Review application to end-users including the planning, object development and verification, SOP/process development, training and end-user support.
Chair J-Review Core Team and interface with data review subject matter experts across functions to drive the implementation and oversight of the J-Review application; engage with super-users to maximize adoption, streamline requirements and define business processes.
Develop and support business processes that define the use of J-Review application and outputs in data review and cleaning activities across various stakeholders in Clinical Operations, Medical, Pharmacology and other R&D Functions; ensure consistent implementation of application across trials.
Develop and maintain SOPs, Work Instructions and other documentation related to J-Review application.
Interface with Integrated Clinical Systems regarding application hosting, maintenance and object development.
Keep oversight of end-to-end dataflow, feeding into and reporting out of the application, including troubleshooting and issue resolution. Interface with DM CROs and other 3rd party vendors to ensure data flow into ICS per requirements.
The Associate Director level requires a minimum of 7-10 years' experience with clinical data management in the pharmaceutical/biotech industry, preferably within the oncology therapeutic area. The level of this position will reflect the experience and seniority of the candidate.
Extensive experience with clinical trial data and how to present clinical data in a meaningful way for data review and cleaning purposes; capable of presenting solutions to meet complex data review and cleaning needs.
Proficient in the use of J-Review; capable of specifying, developing and verifying J-Review objects. Strong understanding of SQL programming. Understanding of R programming an advantage.
Prior experience with Electronic Data Capture systems required, preferably Medidata Rave.
Experience with clinical data interfaces and data exchanges with CROs and other vendors.
Experience working as a liaison between Medical/Clinical and IT. Experience translating medical/clinical user requirements into accurate technical specifications and outputs.
Understanding of IT systems lifecycle; understanding of the application validation process
Project Management skills; excellent organizational skills
Knowledge of clinical trials and the drug development process.
Knowledge of medical and statistical terminology, preferably within oncology.
Understanding of GCP-ICH, SOPs, regulatory requirements and Good Data Management Practices, including a strong understanding of 21 CFR Part 11 and GxP complaint systems.
Good oral and written communication skills
Moreover, the following personal requirements describe you:
You are a dedicated and engaged team player.
You easily build relationships and are a clear and direct communicator.
You have a quality mind-set.
You are adaptable and able to prioritize your work in a fast paced and changing environment; you are agile and resilient.
You drive performance and are a fast learner.
You are a self-starter, quickly able to identify what needs to be done and take action.
Genmab employees work with determination and with respect for each other, consistent with our core values, to achieve our common goals. We give individuals and teams the autonomy to drive development of innovative products and solutions, knowing that integrity is a core value throughout our company. Genmab will offer the successful application a challenging position, where the right candidate will have the opportunity to work with highly specialised people across functions in an informal, multicultural culture, all aiming to make a difference for cancer patients.
Teamwork and respect are central pillars of Genmab's culture and we therefore ensure an inclusive, open, and supportive professional work environment across our international locations. We believe that fostering workplace diversity across social, educational, cultural, national, age and gender lines is a prerequisite for the continued success of the company. We are committed to diversity at all levels of the company and strive to recruit employees with the right skills and competences, regardless of gender, age, ethnicity, etc.
Please note that if you are applying for a position in the Netherlands; Genmab's policy for all permanently budgeted hires in this location is to offer a temporary agreement for one year, followed by a contract for indefinite time regardless of seniority.