Job description
Genmab is focused on the creation and development of innovative and differentiated antibody products, with the aim of improving the lives of cancer patients.
The Role
An External Data Lead role is a clinical data manager with expertise in the data collection of 3rd party data from various external providers (e.g., laboratories, eCOA providers, technology providers, etc.) performing testing or data collection services on behalf of Genmab. The external data manager is also an expert in the integration of external data into the clinical trial database.
This position can be based in Princeton, NJ USA; Copenhagen, Denmark; or Utrecht, The Netherlands.
Responsibilities:
- Drives the data collection strategy for 3rd party vendor generated test results, championing consistency across programs and alignment with analysis and reporting/exploratory research needs of the trial.
- Understands a wide variety of external data types and testing methodologies, especially biomarker testing for oncology trials.
- Serves as the subject matter expert for the setup of external vendors at the trial level.
- Ensure study set up in Metadata Rave and other EDC systems support data collection requirements for the trial and are aligned with external vendor capabilities.
- Liaise with 3rd party vendors and central labs.
- Investigate and resolve issues with external data transfers.
- Contributes to the standardization of data type specifications to ensure external data transfers to meet EDC requirements, ensures alignment of data transfer with CDASH and SDTM requirements, and with the trial analysis and reporting needs.
- Manages and provides oversight to the CRO Creation and maintenance of the data transfer specifications requirements, ensuring vendor data are compatible with the clinical database and SDTM requirements to support data integration, analysis and reporting. Oversight of the standard data formats transferred to the vendor to ensure data expectations for clinical trials.
- Ensures external data study set up and processes promotes collaboration, alignment and consistency across trials, CROs and vendors.
- Contributes to the development and application of systems and optimal approaches to support the collection of external data. Effectively collaborates with DM Start-up Leads to define and implement an industry‐leading electronic data capture capability for external data.
- Provides oversight of external vendors and reviews work delivered by external partners (e.g. laboratories, eCOA providers, technology providers, etc.) performing testing or data collection services on behalf of Genmab.
- Identifies and resolves external data issues which may negatively impact trial deliverables.
- Liaises with internal stakeholders (Biomarker Operations, Data Management, Data Analytics, Medical, Statistics, etc.) and external partners to ensure collaboration to meet Genmab requirements and timelines.
- Follows procedural documents and participates in the review and maintenance of procedural documents to ensure alignment with industry standards.
- Actively participates in and/or leads continuous improvement activities and task forces, as appropriate.
Requirements:
- The Data Manager level requires a minimum of 3-5 experience as an external data manager in the pharmaceutical or CRO industry across all trial phases, preferably within the oncology therapeutic area.
- Project Management skills; excellent organizational skills.
- In depth knowledge of clinical trials and the drug development process.
- In depth understanding of a wide variety of external data types and testing methodologies, hands-on experience with clinical data management within the oncology therapeutic area.
- Knowledge of medical terminology, preferably within oncology
- Knowledge of science or a scientific background is preferred
- Strong understanding of GCPs, SOPs, regulatory requirements, and Good Data Management Practices
- Solid knowledge of CDISC (CDASH, SDTM); understanding of data collection requirements in oncology trials preferred
- Understanding of data visualization software for data review and trial oversight (e.g., J-Review, Spotfire, Qlik Sense, etc.)
Moreover, the following personal requirements describe you:
You are a dedicated and engaged team player. You easily build relationships. You are a clear and direct communicator. You have a quality mind-set. You can prioritize your work in a fast paced and changing environment; you are agile and resilient. You drive performance and are a fast learner. You identify opportunities for improvement and champion best practices.
If you would like additional information about this position before applying using the link, please contact:
Senior Talent Acquisition Manager, Jannie Jensen,
jjn@genmab.com
(DK)
Talent Acquisition Manager, Federica Ianniello,
feia@genmab.com
(NL)
Talent Acquisition Manager, Michele Davino,
mdav@genmab.com
(US)
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 environment, with an aim to make a difference in the lives of people with cancer.
At Genmab, we pride ourselves on our unique culture. We are committed to make a positive impact on the lives of cancer patients. We hypothesize and experiment to seek innovative solutions, no matter the employee’s role; we speak up, empower each other, and embrace change and growth; we respect and celebrate our differences while working as one team. 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. Genmab employees work with determination, challenge the status quo and cultivate a growth mindset in everything we do.
We are committed to fostering workplace diversity at all levels of the company and we believe it is essential for our continued success. No applicant shall be discriminated against or treated unfairly because of their race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability or genetic information.
Genmab US, Inc. is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application on our website:
https://www.genmab.com/privacy/us-applicants-privacy-notice/
Scam alert
Please be alerted that at the moment a recruitment scam involving Genmab is circulating. The scam involves recruiters on LinkedIn and elsewhere, pretending to be Genmab employees, headhunting candidates, asking for CVs and other personal information. The scam can include asking for payment for interviews or interview preparation. This communication is not coming from Genmab, we encourage people to stay alert and not to respond to these queries.
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