Senior Clinical Data Manager

6 maanden geleden

Utrecht, Nederland Genmab Voltijd

The Role

& Department

As the Senior Clinical Data Manager, you will be operationally responsible for tasks within the planning, start-up, conduct and closure of clinical trials from final synopsis and/or a Clinical Trial Team (CTT) is assigned.

 

The Senior Clinical Data Manager will represent Clinical Operations Data Management on the CTT, and with partners and/or Data Management/Statistical vendors. You may support the overall strategy and development of Clinical Operations by participating in task force initiatives within the department.

This role can be located in Copenhagen, Denmark, or Utrecht, the Netherlands, or Princeton, New Jersey, U.S., and is hybrid.

Key responsibilities

You will be part of the cross-functional trial specific CTT and be responsible for core deliverables such as clinical database design/setup, data collection, data validation, manual review, and timelines. All activities will be performed according to quality standards defined by regulations/standards, Genmab SOPs and ICH-GCP.

 

  • Act as the point of contact for DM activities for multiple trials,  provide oversight of data collection and management per regulatory and industry standards

  • Provide oversight of the DM CRO and ensure performance against key indicators; provide DM expertise to trial teams

  • Lead the creation of the Data Review and Cleaning Plan and development of the data cleaning strategy.

  • Provide oversight of the data validation plan and provide DM insight to maximize the data validation strategy

  • Review CRFs to ensure alignment with protocol; lead and perform sponsor acceptance testing of the eCRF; and ensure database structure meets expectations and provide DM insight to promote effective clinical database structure

  • Define and perform data quality checks and take action to ensure data quality

  • Provide oversight of key DM documentation and ensure inspection readiness; ensure documentation is aligned with best practices and provide improvement recommendations based on DM expertise

  • Drive DM oversight of data releases/DBLs and ensure timely delivery of data deliverables in accordance with Genmab SOPs and ICH/GCP;  ensure data quality for analysis and reporting; prepare for regulatory filings and inspections

  • Drive and support vendor qualification for data management; define/specify scope of work for functional tasks

  • Support process improvement and knowledge management by participating in or leading task forces/ projects

Requirements

  • Bachelor's degree in science or related area

  • 5-8+ years of experience in clinical data  management experience in biotech/ pharma industry; significant hands-on end-to-end experience in clinical data management practices

  • Experience within oncology trials highly preferred

  • Experience with clinical trials and the drug development process

  • Significant experience leading data management activities for multiple clinical trials; proficient use of data management systems; advanced knowledge of DM processes, tools, methodologies and documentation; strong understanding of DM strategy

  • Experience and understanding of GCPs, SOPs, regulatory requirements and good data management practices

  • Experience with CDISC (SDTM) as well as data collection requirements in oncology trials preferred

  • Project management experience

 

Furthermore, the following skills are part of your personal toolbox:

  • Planning and organizational skills

  • Team leadership skills

  • Problem solving and decision-making skills

  • Excellent written, verbal, and organizational skills

  • Quality mindset

  • Document creation and management skills

  • Process development skills

  • Being proactive and accountable

  • Analytical skills with the ability to interpret and present clinical data

About You

  • 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

Locations

Genmab leverages the effectiveness of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are designed as open, community-based spaces that work to connect employees while being immersed in our state-of-the-art laboratories. Whether you’re in one of our collaboratively designed office spaces or working remotely, we thrive on connecting with each other to innovate.

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