Genmab · 1 day ago
Associate Director, Clinical Data Manager
United States
Full-time
Remote
Senior Level, Lead/Staff, Director/Executive
$157K/yr - $236K/yr
10+ years expGenmab is an international biotechnology company dedicated to improving patient lives through innovative antibody therapeutics. The Associate Director, Clinical Data Manager will oversee the planning and execution of clinical trials, ensuring data management practices meet regulatory standards and project timelines.
BiotechnologyHealth CareManufacturingMedical
Responsibilities
In the role as “Data Manager” the employee will be part of the cross-functional trial-specific Clinical Trial Team (CTT), and be responsible for delivering core deliverables such as EDC setup, data collection, validation of data in the clinical database prior to data analysis etc. within budget and timelines and according to quality standards defined by regulations/standards, Genmab SOPs and ICH-GCP. The “Data Manager” is responsible for ensuring oversight of the DM vendors and their deliverables
The “Data Manager” is responsible for ensuring appropriate involvement of and communication with relevant stakeholders
As Associate Director, Data Management, the employee may be involved in:
General/Trial specific:
* Give input to the clinical development plans through the Development Operations representatives of the CDT ensuring that data management input/knowledge that could impact the setup and conduct of trials is proactively considered and discussed upon development of the operational strategy of the trials
* Serve as Clinical Data Management representative in Operational Committee/fora with the partners, DM vendors or other vendors handling data
* Participate in working groups *e.g.* Data protection regulation, setup of data in biomarker group, ePRO, IRT etc
* Drive alignment meetings within the data management group
* Attend various working groups where data management expertise is required
* Provide oversight of DM CRO including: Statement of Work; budget; KPIs; and
* other DM CRO trial data management activities from set up to database lock
* Perform vendor oversight related to key deliverables e.g. eCRF design development, review of the eCRF completion guide, UAT, approve eCRF go live, Data management plan, Data validation plan, data cleaning activities, ensuring data transfer specifications with all external data providers e.g. lab, ECG, ePRO etc. , evaluate trends in DM raised queries, ensuring final transfer of data for archiving including development of site CDs, ensuring coding listings are approved etc
* Proactively participate and represent data management in the CTT and provide oversight on progression and status of related activities
* Proactively discuss risks management related to data management activities in relation to trial conduct
* Review and provide input to protocol and amendment development
* Give input to protocol deviations classifications, randomization and stratification plans, tables, figures and listings etc
* Ensure procedures for blinding are in place where applicable
* Support timely delivery of data management deliverables in accordance with Genmab SOP and ICH/GCP
* Attend trial and investigator/monitor meetings as needed
* Participate in definition, review and approval of data packages for Data Monitoring Committee’s, if applicable
* Review and approve any corrections and updates of data packages, if applicable
* Support timely development, update and maintenance of dashboards, if applicable
* CRO selection and collaboration:
* + Support vendor qualification (Request for proposal, bid defense meetings etc.) in terms of Data management, ePRO and IRT related activities and define/specify scope of work for functional tasks
+ Review scope of work in a given trial in collaboration with relevant stakeholders and review/challenge major work orders (WOs)/change orders (COs)/change notification forms (CNFs)
+ Attend operational committee meetings, as applicable
* Compliance:
* + Ensure compliance with relevant regulations, Genmab SOPs and ICH GCP
+ Ensure escalations are made as appropriate to secure proper progress and quality of the trial
+ Ensure compliance with Genmab Code of Business Ethics
+ Ensure that the trial oversight activities are conducted in accordance with the trial oversight plan, e.g. ongoing review of the trial eTMF, support risk assessment analysis in the CTTs, CTT data quality review activities etc
+ Participate in audits and inspections as applicable
+ Ensure timely response to audit/inspection including carrying out a comprehensive root cause analysis and share learnings across trials as applicable
* Project, Department and across departmental activities:
* + Support project submission activities e.g. providing listings and documentation
+ Lead/contribute with knowledge sharing within the department
+ Follow scientific, process and technical progress within the field of data management in drug development and advise of new methodologies that may support innovation and improve efficiencies
+ Contribute on processes optimizations and SOP revisions
+ Lead cross-functional working groups/projects/task forces or new IT tools & technology implementation
Qualification
Required
Bachelor's degree in science or related area (or equivalent)
Minimum of 10+ years of experience in clinical data management
Strong understanding of end‑to‑end trial conduct
Strong Project Management capability
Strategic planning and portfolio thinking
Operational excellence and process improvement mindset
Cross‑functional alignment and communication
Vendor oversight and partnership management
Problem solving, critical thinking and decision making
Knowledge of EDC systems, ICH‑GCP, GDMP, and regulatory expectations
Preferred
Experience in oncology preferred
Benefits
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
Company
Genmab
Genmab is a biotechnology company focused on developing fully human antibody therapeutics for the potential treatment of cancer.
1001-5000 employees
H1B Sponsorship
Genmab has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (14)
2024 (10)
2023 (6)
2022 (3)
2021 (3)
2020 (1)
Funding
Current Stage
Public CompanyTotal Funding
$11.7BKey Investors
Morgan Stanley Senior FundingGlaxoSmithKlineIndex Ventures
2025-11-18Post Ipo Debt· $6B
2025-09-29Post Ipo Debt· $5.5B
2010-07-01Post Ipo Equity· $134M
Leadership Team
Anthony Pagano
Chief Financial Officer
Anthony Mancini
EVP & Chief Operating Officer
Recent News
pharmaphorum
2026-01-03
Clinical Trials Arena
2026-01-03
2025-12-31
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