27 days old

Senior Manager, Clinical Data Standards

Princeton, NJ 08542
  • Job Code
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 & Department

As a Senior Manager, Clinical Data Standards you will be in Clinical Data Standards and operationally responsible for the oversight of Clinical Data Management activities related to the effective planning, and timely delivery of complete, high quality and reliable clinical trial data. As a Senior Manager, Clinical Data Standards you may act as an eDC data collection/eCRF specialist, promoting the delivery of clinical data that are aligned with study protocols, Genmab standards, and industry standards (CDISC). You will report to the Director, Clinical Data Management Operations, Standards and work closely with the Associate Director, Clinical Data Systems, Clinical Data Management.

Key responsibilities include:

  • Provide clinical data collection expertise to support high-quality data deliverables
  • Ensure the clinical data collection is aligned with trial operational strategy, clinical trial requirements, and with Clinical Data System requirements to promote consistency across the Genmab portfolio
  • Work in conjunction with the Programming Clinical Data Standards Manager and Clinical Data Systems Manager to ensure the quality and consistency of clinical trial data standards across the portfolio.
  • Participate in the Global Standards Governance and Global Standards Forums
  • Non-exclusive summary of key areas of responsibility are:
    • Provide CRF build guidance
    • Provide Visit Map (Structure) guidance
    • Development and maintenance of CRF Allowable Modifications and guidance on its intended usage
    • New eCRF content/specifications development and testing
    • Edit Check and Dynamic specifications development in advance of technical build
    • CRF Completion Guidelines development and maintenance
    • Review and provide input to ICF Template and Protocol/Amendments for the impacts on existing and new Clinical Data Standards
    • Tracking and Communication of new and revised Clinical Data Standards
  • Contribute to the maintenance and improvement of clinical data standards tools and processes
  • Proactively discuss and address risk management pertaining to data management start-up activities in relation to trial conduct
  • Contribute to the resolution of eDC related issues both technical and process related
  • Contribute to the availability and utilization of data collection processes for blinding
  • Support, train and advise colleagues regarding data management related processes/issues and contribute to the development of associated training materials
  • Support the overall development strategy of Clinical Operations by attending/leading task force initiatives within the department and/or as part of cross-departmental teams
  • Serve as Clinical Operations representative in Operational Committee/fora with the partners, DM/stat vendors or other vendors handling data.
  • Participate in audits and inspections
  • Act as a mentor for new and/or junior Data Managers
  • The Employee shall also render such other related services and duties as may be assigned to him/her from time to time by his/her supervisor.

Requirements - what you must have

  • Bachelor of Science degree required and/or bachelor's degree in a related field of study
  • 10+ years of direct experience in Clinical Data Standards and/or Clinical Data Management in the pharmaceutical industry or similar (e.g., Biotech)
  • Experience required in Clinical Data Standards or Study Start-Up Clinical Data Management
  • Technical proficiency in EDC (RAVE preferred), medical knowledge, and understanding of clinical research, strong knowledge of DM processes, tools, methodologies, and documentation
  • Oncology and immunology trial experience
  • The ability to operationalize medical and analytical requests into technically feasible data collection modalities by interpreting, clarifying, and understanding the requests and evaluating alignment with the overall clinical development strategy, Genmab Clinical Data Standards, industry standards, and regulatory requirements (CDISC)
  • Additional competencies:
    • Planning and organization
    • Clinical development/trial conduct, including ICH-GCP
    • Team leadership and collaboration
    • Problem solving and decision making
    • Communicates directly, including clear and concise communication of scientific/technical information
    • Document creation and management
    • Developing processes
    • Driving performance; proactive and accountable

About You - additional qualities you bring to the table

  • 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

Where you will work

This role can be in Copenhagen, Denmark or Princeton, NJ, US and can be hybrid or remote-based.

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.

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 .

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.

Posted: 2023-01-10 Expires: 2023-02-08
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Princeton, NJ 08542

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