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 now searching for an experienced Senior Programming Manager, Clinical Data Standards, to be part of Programming team in Copenhagen.
The Senior Programming Manager, Clinical Data Standards is responsible for the establishment, governance, and integrity of clinical trial data standards. This position will ensure the quality and consistency of clinical trial data standards to support the portfolio towards the ultimate objective of data quality and consistency across programs and systems. This new role reports to the Senior Director, Head of Programming.
• Develop and implement integrated data standards solutions, from data collection to analysis, that support the scientific need of a study/program while ensuring quality, consistency and compliance to CDISC standards and other industry standards that supports the exchange of data, reporting, and analysis.
• Serve as a subject matter expert on all aspects of standards development that includes industry standards (CDISC), regulations, and processes.
• Chairs the standards governance boards to define, maintain and enforce standards across the Clinical Data Sciences, Clinical Digital Solutions, and the Clinical Operations organization to insure consistency for studies. Governance board will also include R&D cross-functional representation, e.g safety, clinical development.
• Ensure work carried out in accordance with applicable SOP’s and working practices, as well as global agency regulations/guidance’s.
• Key data standards contact for inspections/audits in liaison with QA.
• Directly supports knowledge development of others as a subject matter expert on data standards, reporting and analysis standards, change control management and related tools/applications.
• Creates quality control processes, metrics and other measures to ensure compliance with standards.
• Creates any needed documentation and training for standard processes, change control management and tools.
• Responsible for defining standards specifications working closely with implementation support teams (database set-up, completion guidelines, CRF designers, procedures, algorithm specifications and reporting requirements).
• Facilitate a culture of continuous process improvement and a high level of customer service by maintaining and improving the standards processes associated with standards creation, maintenance, decision-making and implementation.
• Working with Digital Solutions and IT, support the implementation of future strategies and technology-enabled processes and tools for clinical trials standards, change control management and the exchange of standards information to internal downstream consumers and externally consumers.
Bachelor’s degree in Statistics, Computer Science, Life Sciences. Master’s degree in Statistics, Computer Science, Life Sciences preferred.
• Senior Programming Manager, Clinical Data Standards: At least 8 years relevant experience in a pharmaceutical, biotech, CRO or Regulatory Agency, with at least 6 years of experience in the areas of design, support of large-scale distributed databases and data standards administration.
• Demonstrated experience using relational databases (e.g. MDR, MS SQL Server, MS Access, Oracle, SAS, or R)
• Demonstrated knowledge of clinical research, metadata management, industry standards (CDISC), FDA & ICH, GCP, and related regulatory requirements
• Demonstrated experience managing multiple tasks, complex projects and working with cross functional teams delivering to project and portfolio timelines and metrics.
• Strong verbal and written communication skills; independent and effective working in a multi-study, multi-disciplinary atmosphere in a matrix environment
• Experience in clinical data management and/or trial management experience with technical expertise in standards management and implementation.
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.
In case you have any questions, please feel free to reach out to Beirholm Search, Hanne Beirholm at firstname.lastname@example.org or phone 29440080.