Senior Clinical Oversight Associate, Operational Data Job at Genmab
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
Genmab is growing and to support this, we are looking for a candidate within Trial Reporting that can drive and support the framework for operational data quality and support the Clinical Trial Analytics & Visualization team.
You are an expert in assessing how to best fulfill business requirements, facilitating data review analysis and reporting via interactive solutions and traditional outputs. You constantly think out of the box and internal customer in mind to ensure solutions are fit for purpose and deliver high business value.
You have experience in assessing and implementing ICH GCP requirements into business processes driving sponsor oversight and risk based monitoring activities, helping the team ensure value creation via fit for purpose visualizations and dataflow.
The position is part of a team that consists of GenSense Leads and Developers, and you will have high influence on the trial reporting development and maintenance, reporting to the Associate Director, Analytics & Visualizations.
Responsibilities
- Supporting oversight from an operational data excellence / quality perspective at portfolio level (cross trial, cross app)
- Hands on operational data surveillance, cleaning, and dissemination of operational trial information/reports
- Supporting the trial teams per ongoing operational data review and oversight of data entry in Genmab trackers by comparing input in datasets with outputs in visuals (apps / dashboards)
- Identification and channeling systemic issues and any serious GAPs in the data towards internal teams at Genmab or towards CRO
- Support QC of outputs (e.g., trial summaries) ahead of final distribution
- Maintaining practical guidance on operational data entry
- Drive centralized data operational cleaning tasks (e.g., clean institution names) according to existing/new standards and conventions
- Ad-hoc support of Inspection Readiness task forces
- Entering any centralized data in master trackers (supporting input to master list of trials and key dates/milestones)
- Maintain operational mapping tables and standards
- Dissemination of reports across the organization
- Project resource on Operational Data Capture
- support configuration updates of tracking solutions supporting official data entry responsibilities with the CTMs (Clin Ops and facilitator of operational Clin Dev data)
- support data migrations
- Develop best practices
- support/develop framework for operational data quality (e.g., metrics and dashboard)
- support the link between operational data quality and inspection readiness (baseline, signals for inconsistencies, necessary cleaning updates, final QC)
- identify inconsistencies on criteria, terminology, and definition level flagging need to updates/maintenance
- stakeholder management per data quality priorities/incidents across functional areas (focus on key data points)
Requirements
- Knowledge and understanding of clinical research, ICH-GCP and GDPR.
- Preferably 1-2 years from a similar position within the pharma industry.
- Good understanding of new solution implementation process/system incl. assessment of synergies, dependencies towards successful adoption and technical expertise.
- Excellent written and verbal communication and interpersonal skills.
- Strong organizational skills, ability to prioritize, proactively identify, and resolve issues.
- A team player with demonstrated ability to collaborate with a diverse group of internal and external stakeholders (e.g., Clinical Trial Managers, Medical and Medical Affairs teams, Data Managers, CRO personnel) to support the report development strategy.
Besides all the technical and educational requirements, we need a person with strong communication skills - for instance, an agile communication with cross functional stakeholders - as well as technical experts.
You hold a holistic understanding of the overall dataflow, data review and decision-making outputs in clinical trials, and the capability to extend that into complex oncology trials, with a variety of data and constant tailoring into new situations and needs. Adaptability for changing needs and handling a series of parallel tasks and discussions.
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.
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.
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 initially to offer a fixed-term employment contract for a year, if the employee performs well and if the business conditions do not change, renewal for an indefinite term may be considered after the fixed-term employment contract.
Genmab A/S is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with you application on our website
https://www.genmab.com/privacy
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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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