(Senior) Manager, External Data Acquisition, Clinical Data Management

5 maanden geleden

Utrecht, Nederland Genmab Voltijd

The Role

 

As a (Senior) Manager in External Data Acquisition, you will play a pivotal role within our Clinical Data Management team. Your primary responsibility will be to oversee the acquisition and integration of third-party data (e.g., laboratories, eCOA providers, technology providers, etc.) who perform testing or data collection services on behalf of Genmab, ensuring its alignment with clinical trials' objectives and regulatory standards. 

 

Responsibilities 

  •  Lead and provide strategic insights into protocol development, specifically focusing on external data collection and integration. 

  • Standardize data type specifications to align with Electronic Data Capture (EDC) requirements and clinical trial objectives. 

  • Ensure that data transfer processes comply with CDASH and SDTM standards, facilitating efficient data analysis and reporting. 

  • Develop detailed data transfer specifications for acquiring external data from third-party vendors. 

  • Coordinate with vendors to guarantee that data collection is compatible with clinical databases and meets SDTM requirements. 

  • Oversee Data Management Contract Research Organizations (DM CROs) for seamless external data transfers. 

  • Review and assess vendor contracts, setup specifications, and test data transfers. 

  • Proactively identify and resolve issues related to external data transfers throughout the trial lifecycle. 

  • Collaborate with internal teams (Biomarker Operations, Data Management, Data Analytics, Medical, Statistics, etc.) and external partners to ensure adherence to Genmab’s requirements and timelines. 

 

Requirements 

 

  • Bachelor's degree in science or a related field. 

  • 3-5+ years of experience in clinical data management with a focus on external data in the biotech/pharma industry. 

  • Profound knowledge of oncology trials, EDC systems, and technical aspects of data transfer. 

  • Strong understanding of data management processes, tools, methodologies, and documentation. 

  • Familiarity with GCPs, SOPs, regulatory requirements, and good data management practices. 

  • Proficiency in CDISC (SDTM) standards and clinical data standards development. 

  • Proven project management skills. 

 

About You: 

 

  • Passionate about Genmab's mission and driven to make a significant impact in a dynamic biotech environment. 

  • Exceptional technical expertise in clinical data management and external data acquisition. 

  • Ability to thrive in a fast-paced setting, maintaining the quality and integrity of clinical data. 

Where you will work

  • This role is remote in the US. The US candidates must live in the Eastern Time Zone.

  • Copenhagen, DK, or Utrecht, the Netherlands, and can be hybrid (3 days in the office/2 remote).

For US based candidates, the proposed salary band for this position is as follows:

$,.00---$,.00

The actual salary offer will carefully consider a wide range of factors, including your skills, qualifications, experience, and location. Also, certain positions are eligible for additional forms of compensation, such as bonuses.

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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