Senior Manager, External Data Quality Manager

n we would love to have you join us!

• The Role:

  As a (Senior) Manager in External Data Quality Management (Contractor), you will play a critical role within our Clinical Data Management team, primarily responsible for overseeing the quality and reconciliation of external data provided by third-party vendors, such as laboratories, eCOA providers, and technology vendors. Your expertise will be pivotal in integrating external data into clinical trial databases while ensuring the highest standards of data accuracy and consistency across all studies.

  Responsibilities:

  • Oversee and ensure the quality of data provided by external third-party providers.

  • Coordinate with internal stakeholders and external partners to optimize data collection strategies to meet trial analysis, reporting, and research needs.

  • Develop and execute study-specific data reconciliation plans in collaboration with Data Management (DM) and Clinical Research Organizations (CROs).

  • Manage third-party vendors and central labs, including conducting performance reviews, resolving issues, and spearheading process improvement initiatives.

  • Ensure timely and accurate delivery of external data, managing timelines and project deliverables effectively.

  • Support process improvements and foster knowledge sharing within the data management teams.

  Requirements:

  • Bachelor's degree in science or related field.

  • Minimum of 5 years of experience in external data management, with extensive experience in third-party vendor management and data oversight.

  • Experience in clinical data management within a clinical research environment, preferably including oncology trials.

  • Proficiency in data reconciliation processes and a thorough understanding of various data types, testing methodologies, and biomarker testing specific to oncology trials.

  • Exceptional project management and communication skills, with the ability to work collaboratively in a multidisciplinary environment.

  • Strong organizational, analytical, and problem-solving skills, with the ability to work independently and thrive in a dynamic, fast-paced environment.

  • Familiarity with clinical trial data systems, Electronic Data Capture (EDC), and related applications is preferred.

  • In-depth knowledge of clinical trials, drug development processes, Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), regulatory requirements, and Good Data Management Practices.

  Additional Job Description
  Additional Job Description

  Trial Clinical Data Mgmt.

  Act as the point of contact for DM activities for a trial, provide oversight of data collection and management per regulatory and industry standards
  Provide oversight of the DM CRO and ensure performance against key indicators
  Create the Data Review and Cleaning Plan; provide DM insight into data cleaning strategy; provide oversight of the data validation plan
  Review CRFs to ensure alignment with protocol. Lead and perform sponsor acceptance testing of the eCRF. Ensure database structure meets expectations
  Perform data quality checks and take action to ensure data quality
  Provide oversight of key DM documentation and inspection readiness of documentation; ensure documentation is aligned with best DM practices
  Provide DM oversight of data releases/DBLs to ensure quality data is ready for analysis and reporting
  Contribute to continuous process improvement in DM through suggestions and delivering on assigned tasks

  Specialist Data Mgmt.

  Act as the point of contact for start-up DM activities for trials
  Provide oversight of the DM CRO and ensure planning, coordination of DM start-up activities and timely delivery of high-quality clinical database
  Provide input to trial design, protocols and amendments to ensure protocol enables proper data collection to support analysis and reporting
  Gather data collection requirements from stakeholders for EDC/other applications that collect clinical trial data
  Ensure eCRF/DTS specifications are aligned with industry standards, CDISC requirements and company clinical data collection standards
  Review CRFs/DTSs to ensure alignment with protocol. Perform user acceptance testing of the eCRF/review DTSs; ensure clinical database structure meets expectations
  Contribute to the data collection strategy; provide input to data capture tools
  Participate in the development, maintenance and governance of clinical data collection standards
  Provide oversight of key DM documentation and inspection readiness of documentation; ensure documentation is aligned with best DM practices
  Contribute to continuous process improvement in DM through suggestions and delivering on assigned tasks

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

$133,040.00 - $199,560.00

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 discretionary bonuses and long-term incentives.

When you join Genmab, you're joining a culture that supports your physical, financial, social, and emotional wellness. Within the first year, regular full-time U.S. employees are eligible for:

• 401(k) Plan: 100% match on the first 6% of contributions

• Health Benefits: Two medical plan options (including HDHP with HSA), dental, and vision insurance

• Voluntary Plans: Critical illness, accident, and hospital indemnity insurance

• Time Off: Paid vacation, sick leave, holidays, and 12 weeks of discretionary paid parental leave

• Support Resources: Access to child and adult backup care, family support programs, financial wellness tools, and emotional well-being support

• Additional Perks: Commuter benefits, tuition reimbursement, and a Lifestyle Spending Account for wellness and personal expenses

About You

• You are genuinely passionate about our purpose

• You bring precision and excellence to all that you do

• You believe in our rooted-in-science approach to problem-solving

• You are a generous collaborator who can work in teams with a broad spectrum of backgrounds

• You take pride in enabling the best work of others on the team

• You can 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 maximizes the efficiency of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are crafted as open, community-based spaces that work to connect employees while being immersed in our powerful laboratories. Whether you're in one of our office spaces or working remotely, we thrive on connecting with each other to innovate.

About Genmab

Genmab is an international biotechnology company with a core purpose to improve the lives of patients through innovative and differentiated antibody therapeutics. For 25 years, its hard-working, innovative and collaborative team has invented next-generation antibody technology platforms and harnessed translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. By 2030, Genmab's vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO®) antibody medicines.

Established in 1999, Genmab is headquartered in Copenhagen, Denmark with international presence across North America, Europe and Asia Pacific. For more information, please visit Genmab.com and follow us on LinkedIn and X.

Genmab 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 Job Applicant Privacy Notice (genmab.com).

Please note that if you are applying for a position in the Netherlands, Genmab's policy for all permanently budgeted hires in NL 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.