Clinical Trial Manager

Genmab A/S; Plainsboro Township (NJ); Hybrid; USD 113,000 - 171,000; Full time

Job summary

An innovative biotechnology company is seeking a Clinical Trial Manager to lead and oversee clinical trials that significantly impact patient lives. This role involves developing operational plans, managing vendor relationships, and ensuring compliance with regulatory standards. The ideal candidate will thrive in a collaborative environment, bringing precision and excellence to their work. With a commitment to improving cancer treatment, this position offers the chance to be at the forefront of groundbreaking medical advancements. Join a passionate team dedicated to making a difference while enjoying a supportive and dynamic workplace.

Benefits

Health Insurance

Retirement Plan

Flexible Working Hours

Paid Time Off

Professional Development Opportunities

Qualifications

• Experience in managing clinical trials and vendor relationships.
• Strong understanding of regulatory requirements and compliance.

Responsibilities

• Develop operational plans and oversee trial execution.
• Manage vendor relationships and ensure quality standards.

Skills

Clinical Trial Management

Vendor Management

Regulatory Compliance

Risk Management

Education

Bachelor's Degree in Life Sciences

Master's Degree in Clinical Research

Tools

eTMF Systems

Clinical Trial Management Software

Job description

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!

Clinical Trial Manager

Overview

The Clinical Trial Manager (CTM) is accountable for delivery of selected and/or regional deliverables within a trial (e.g., manage and oversee vendor deliverables, collaborate with functions toset up activities [e.g., Calyx, IRT,eRT], support site activation and recruitment, support data review/cleaning activities, support PI/ICF development). Scopeof responsibilities depending on number of patients/sites/size of trial.

Roles & Responsibilities

Trial Planning and Oversight

• Develop operational plans, manuals and charters for the trial
• Review protocol and protocol amendments
• Create and coordinate the writing of Investigational MedicinalProduct (IMP) Plan (until process moved to GDS responsibilityexpected Q4/ end October after this date responsible for co-authoring only )
• Coordinate the development of the Trial Oversight Plan
• Review the Investigator's Brochure (IB) from DevOps perspective
• Review the Clinical Trial Application (CTA) submission package
• Review Regulatory Green Light (RGL) packages in accordance withQDOC-08903
• Review the Development Safety Update Report (DSUR)
• Develop Global Master ICF
• Follow up on Trial Oversight identified findings during Oversightuntil closure

Site Selection and Management

• Drives site selection in collaborate with Start-up
• Review/approve SSV summary
• Coordinate the review of the CRO country-specific informedconsent forms (ICFs) with internal stakeholder
• Coordinate translation/back translation process of ICFs

Management and Oversight

• Oversee vendor management across vendors (does not includebudget/change orders)
• Approve key CRO staff e.g.,Clinical leads, or Trial specific CRA(not including CRAs part of the partnership dedicated model whichis managed via Oversight Manager)

Trial Execution and Monitoring

• Conduct initial Protocol Deviation (PD) assessments and tracktrends
• Ensure the ongoing completeness of the electronic Trial Master File(eTMF)
• Keep the Trial Management Dashboard (TMD) and portfolio app inGenSenseup to date
• Drive the ODB review meeting
• Participate in RBQM activities (as implemented going forward)
• Assist in maintenance of CTT issuelog in collaboration with GCTM
• Collaborate or manage study escalations both internal & external
• Support GCTM toAssess KPI/KQI at the trial level
• Support QA in site audit activities and potentially vendoraudits(supporting with trial information and collection and providing ofrelevant trial documents)
• Conduct booster visits
• Participate in inspection readiness activities as assigned
• Oversee and collaborate with CTT members/vendors/assignedfunctional representatives on tracking and reconciliation of trialrelated items such as scans, blood samples etc.

Additional Job Description

• Lead the cross-functional trial-specific Clinical Management Team (CMT), including the CROs, to deliver clinical trials within budget and timelines and according to quality standards defined by regulations, Genmab SOPs and ICH-GCP
• Engage with internal and external stakeholders to drive collaboration and coordination for trial progress
• Participate in CRO selection, scope of work definition, and ongoing management for assigned trials
• Ensure escalations are made as appropriate to secure proper progress and quality of the trial
• Participate in audits and inspections as required and drive timely response
• Update and maintain trial budgets, including forecasting, accruals and invoice management
• Proactively lead risk management assessment of the conduct of the trial related to patient safety and data integrity

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

$113,840.00---$170,760.00

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 bonuses.

Regular full-time U.S. employees are eligible to enroll in Genmab benefits. Our benefits package is crafted to help employees feel supported and cared for in all aspects of life — physical, financial, social, and emotional.

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.