Associate Director, Clinical Data Management

Genmab; Princeton (NJ); On-site; USD 157,000 - 236,000; Full time

Benefits offered by this job

401(k) matching

Health benefits

Parental leave

Wellness programs

Job summary

Genmab is seeking an Associate Director of Clinical Data Management in Princeton, NJ. The role blends Data Manager responsibilities with leadership across trials, vendors, and data governance.

You will drive DM strategy, ensure quality, and lead cross-functional teams to deliver high-integrity data for regulatory submissions. The position requires 10+ years in clinical data management, expertise in CDISC/SDTM, and a proven track record in all trial phases.

Qualifications

• Bachelor's degree in science or related area (or equivalent).
• 10+ years of experience in clinical data management in biotech/pharma.
• Experience in all phases of clinical trials and drug development.
• Significant experience leading data management activities in trials; advanced DM systems.
• Knowledge of DM processes, tools, methodologies and documentation; DM strategy.

Responsibilities

• Lead or contribute to data management activities across trials within one or more development projects.
• Oversee DM vendors, budgets, KPIs and data transfer specifications.
• Participate in cross-functional trials and operational committees as needed.
• Provide input to development plans, protocol/deviation input, and data governance.
• Ensure compliance with ICH-GCP, DM SOPs, and regulatory requirements.
• Support timely delivery of DM deliverables and data packages for DM committees.
• Lead or contribute to cross-functional working groups and IT tool implementations.

Skills

Project Management

Planning and organization

Clinical development/trial conduct

Team leadership

Communication

Problem solving

Quality mindset

Document creation and management

Process development

Proactive and Accountable

Analytical

IT skills

Education

Bachelor's degree in science or related area

Job description

Position

Associate Director, Clinical Data Management

Department

Clinical Data Integration and Reporting

Reports to

Director of DM, Team Lead, Clinical Data Management

Overview

An Associate Director, Data Management can hold two roles; a “Lead Data Manager” role and/or a Data Manager role, referred to as “Data Manager”.

As “Data Manager” the employee is operationally responsible for the planning, start-up, conduct and closure of clinical trials from the point in time where a final synopsis and/or a Clinical Trial Team (CTT) is assigned.

In the “Lead Data Manager” role, the employee may act as a Data Management Lead and be responsible for the oversight and consistency across the trials within one or more development projects. The DM Lead will provide asset-level DM expertise, ensure project level standards are established and followed, and ensure consistency of DM processes across all trials within the asset. The DM Lead will provide support to trial Data Managers within the asset to ensure consistency of data management practices across the asset. When applicable, the DM Lead will provide data management expertise to the Clinical Development Team and to co-sponsor collaborations/external partners. The DM Lead will participate in and drive implementation of lessons learned and of new/innovative procedures to ensure high standards/improvement of data management related processes/systems, which may involve cross departmental stakeholders.

The employee may represent Clinical Data Management in Operational Committee’s/fora with the partners and/or DM vendors.

As Associate Director, Data Management the employee will support /train colleagues in and advise on handling of data management related processes/issues and may act as a mentor.

Moreover, the employee shall support the overall strategy and development of Clinical Data Management by attending/leading task force initiatives within the department and/or as part of cross-departmental teams.

Responsibilities/tasks

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:

• 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

Competencies

• Project Management
• Planning and organization
• Clinical development/trial conduct, including ICH-GCP
• Team leadership
• Excellent communication skills and able to communicate scientific communication in clear and concise manner
• Problem solving and decision making
• Quality mindset
• Document creation and management
• Process development
• Proactive and Accountable
• Analytical and ability to interpret and present clinical data
• IT skills

Requirements

Bachelor's degree in science or related area (or equivalent)

10+ years of experience in clinical data management experience in biotech/ pharma industry; significant hands-on experience in all aspects of data management.

Experience within all phases of clinical trials.

Experience with clinical trials and the drug development process

Significant experience leading data management activities in clinical trials; advanced use of data management systems; advanced knowledge of DM processes, tools, methodologies and documentation; advanced understanding of DM strategy

Experience with CDISC (SDTM); as well as data collection requirements in clinical trials

Experience and understanding of the complex and interdependent relationships between protocol development, data collection, data review and cleaning activities and analysis and reporting in clinical trials

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

Experience working on early and late-stage submissions as per local/regulatory requirements

Experience working in and leading cross-functional teams

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

$157,360.00---$236,040.00

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

Further details on eligibility for compensation and benefits based on role will be provided during the recruitment process

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.

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