IRT Manager

Genmab • Princeton, NJ

21h • Hybrid

About The Position

The role IRT Manager supports Global Clinical Drug Supply. Responsibilities: IRT Project (i.e., Trials) Management Responsible for the lifecycle (set-up, maintenance, and decommissioning) of trial specific IRT systems including: Plan and coordinate the IRT implementation (initial/amendments), design requirements, UAT planning & execution, integrations, documentation and training in accordance with trial protocol and timelines with the relevant cross-functional stakeholders Enforces the use of IRT system standards Mitigates risk related to IRT system implementation through proper risk assessments Manage and maintain internal and external stakeholder’s expectation for IRT service and system delivery undefined Manage multiple projects concurrently, managing project schedules, and ensuring quality deliverables in a dynamic environment Communicate effectively with stakeholders on project status and coordinate activities with the clinical trial teams, as necessary Participates in or leads Genmab operational planning sessions undefined IRT Vendor Management Provide trial specific inputs to KPIs & metrics for trend analysis of potential and current risks/issues Participate in IRT vendor operational oversight activities for assigned clinical trials, as appropriate Collaborate closely with IRT vendor project manager and operational team members for assigned trials Provide inputs and/or participate for IRT vendor audits and inspection readiness activities, and assist with investigations and/or quality related events for IRT Provides support for problem resolution, root cause analysis, corrective actions between IRT vendor and clinical trial teams undefined Continuous Improvement Provide input areas for continuous improvement Support assigned project improvement activities Provide mentoring for associate level team members as well as facilitate cross functional training for improvement/initiative rollouts May provide support for the creation / maintenance of documentation, such as, but not limited SOPs, work instructions, and job aids Other Responsibilities Ensures the quality and inspection readiness of all Genmab IRT systems Supports the records retention and clinical data maintenance Responsible to be compliant with Genmab´s quality system Provide mentoring and training to IRT team members, as appropriate

Requirements

• experience working in a fast-growing, dynamic company (or a strong desire to)

Nice To Haves

• 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 work hard and are not afraid to have a little fun while you do so!

Responsibilities

• Plan and coordinate the IRT implementation (initial/amendments), design requirements, UAT planning & execution, integrations, documentation and training in accordance with trial protocol and timelines with the relevant cross-functional stakeholders
• Enforces the use of IRT system standards
• Mitigates risk related to IRT system implementation through proper risk assessments
• Manage and maintain internal and external stakeholder’s expectation for IRT service and system delivery
• Manage multiple projects concurrently, managing project schedules, and ensuring quality deliverables in a dynamic environment
• Communicate effectively with stakeholders on project status and coordinate activities with the clinical trial teams, as necessary
• Participates in or leads Genmab operational planning sessions
• Provide trial specific inputs to KPIs & metrics for trend analysis of potential and current risks/issues
• Participate in IRT vendor operational oversight activities for assigned clinical trials, as appropriate
• Collaborate closely with IRT vendor project manager and operational team members for assigned trials
• Provide inputs and/or participate for IRT vendor audits and inspection readiness activities, and assist with investigations and/or quality related events for IRT
• Provides support for problem resolution, root cause analysis, corrective actions between IRT vendor and clinical trial teams
• Provide input areas for continuous improvement
• Support assigned project improvement activities
• Provide mentoring for associate level team members as well as facilitate cross functional training for improvement/initiative rollouts
• May provide support for the creation / maintenance of documentation, such as, but not limited SOPs, work instructions, and job aids
• Ensures the quality and inspection readiness of all Genmab IRT systems
• Supports the records retention and clinical data maintenance
• Responsible to be compliant with Genmab´s quality system
• Provide mentoring and training to IRT team members, as appropriate

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: Manager
• Education Level: No Education Listed