Senior Clinical Data Manager

Genmab • Plainsboro Township, NJ

29d

About The Position

At Genmab, we are dedicated to building extra[not]ordinary® futures, together, by developing antibody products and groundbreaking, knock-your-socks-off KYSO antibody medicines® that change lives and the future of cancer treatment and serious diseases. We strive to create, champion and maintain a global workplace where individuals’ unique contributions are valued and drive innovative solutions to meet the needs of our patients, care partners, families and employees. Our people are compassionate, candid, and purposeful, and our business is innovative and rooted in science. We believe that being proudly authentic and determined to be our best is essential to fulfilling our purpose. Yes, our work is incredibly serious and impactful, but we have big ambitions, bring a ton of care to pursuing them, and have a lot of fun while doing so. Does this inspire you and feel like a fit? Then we would love to have you join us! A Senior Data Manager can hold two roles; a “Lead Data Manager” role and 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, Provide oversight of the DM CRO and ensure performance against key indicators. As “Lead Data Manager” the employee may act as “project” Data Manager and be responsible to oversight and ensure consistency cross more trials within one or more development projects. The Lead Data Manager will participate in and drive implementation of lessons learned and new, innovative procedures to ensure high standards/improvement of data management related processes and 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 Senior Data Manager 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.

Requirements

• Bachelor's degree in science or related area
• 5-8+ years of experience in clinical data management in biotech/ pharma industry; significant hands-on end-to-end experience in clinical data management practices.
• 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
• Project management experience
• The Employee must have competences within the following areas:
• Planning and organization
• Clinical development/trial conduct, including ICH-GCP
• Team leadership
• Problem solving and decision making
• Good communication skills and able to communicate scientific communication in clear and concise manner
• Quality mindset
• Document creation and management
• Process development
• Proactive and Accountable
• Analytical and ability to interpret and present clinical data
• IT skills (proficiency with data management systems)
• In-depth knowledge of regulatory guidelines (e.g., FDA, EMA, ICH) and industry standards for clinical data management.

Nice To Haves

• Experience within oncology trials highly preferred

Responsibilities

• 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
• 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
• 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
• 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
• 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 and participate in cross-functional working groups/ projects/task forces

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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 1,001-5,000 employees