Senior Clinical Trial Manager
2 weeks ago
We are seeking a highly skilled Senior Clinical Trial Manager to join our team at Genmab. As a key member of our Clinical Operations department, you will be responsible for delivering key trial management elements on oncology trials and ensuring sponsor engagement.
Key Responsibilities- Develop operational plans, manuals, and charters for trials
- Review protocol and protocol amendments, as well as other trial documents
- Create and coordinate the writing of Investigational Medicinal Product (IMP) Plans
- Coordinate the development of Trial Oversight Plans
- Review Clinical Trial Application (CTA) submission packages
- Review site regulatory documents
- Develop Global Master Informed Consent Forms
- Coordinate resolution of site or monitoring issues with CROs or other vendors
- Drive site selection in collaboration with Start-up
- Review and approve Site Selection Summary (SSV) documents
- Coordinate the review of CRO country-specific informed consent forms (ICFs) with internal stakeholders
- Coordinate translation and back-translation processes for ICFs
- Oversee vendor management across vendors (excluding budget and change orders)
- Approve key CRO staff, including Clinical Leads and Trial-specific CRAs
- Conduct initial Protocol Deviation (PD) assessments and track trends
- Ensure the ongoing completeness of the electronic Trial Master File (eTMF)
- Keep the Trial Management Dashboard (TMD) and portfolio app in GenSense up to date
- Drive ODB review meetings
- Participate in Risk-Based Quality Management (RBQM) activities
- Assist in maintaining the CTT issue log with GCTM
- Collaborate or manage study escalations, both internal and external
- Support GCTM in assessing KPI/KQI at the trial level
- Support QA in site audit activities and potential vendor audits
- Conduct booster visits
- Participate in inspection readiness activities, as assigned
- Oversee and collaborate with CTT members, vendors, and assigned functional representatives on tracking and reconciliation of trial-related items, such as scans and blood samples
- Bachelor's or Master's degree in a relevant field, such as medical, biological, pharmaceutical science, or equivalent
- Minimum 5 years of experience in clinical trial management, preferably from a pharmaceutical company or CRO
- Experience in oncology and/or first-in-human trials is preferred
- Proven skills in working in a project-oriented and international organization
- Excellent communication skills in English, both written and spoken
We are looking for a dedicated team player who enjoys leading teams and inspiring trust among colleagues. You should have a quality mindset, be able to prioritize your work in a fast-paced and changing environment, and be result- and goal-oriented, committed to contributing to the overall success of Genmab.
What We OfferGenmab offers a competitive salary and benefits package, as well as opportunities for professional growth and development. If you are passionate about our purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatment, we encourage you to apply.
-
Senior Clinical Trial Manager
3 weeks ago
Plainsboro, New Jersey, United States Genmab Full timeAbout the RoleWe are seeking a highly skilled Senior Clinical Trial Manager to join our team at Genmab. As a key member of our Clinical Operations department, you will be responsible for delivering key trial management elements on oncology trials and ensuring sponsor engagement.Key ResponsibilitiesDevelop operational plans, manuals, and charters for...
-
Senior Clinical Trial Manager
3 weeks ago
Plainsboro, New Jersey, United States Genmab Full timeJob OverviewGenmab is seeking a highly skilled Senior Clinical Trial Manager to join our team. As a key member of our Clinical Operations department, you will be responsible for delivering key trial management elements on oncology trials and ensuring sponsor engagement.The ideal candidate will have a strong understanding of trial execution, experience in...
-
Senior Clinical Trial Manager
3 weeks ago
Plainsboro, New Jersey, United States Genmab Full timeJob OverviewGenmab is seeking a highly skilled Senior Clinical Trial Manager to join our team. As a key member of our clinical operations team, you will be responsible for delivering key trial management elements on oncology trials and ensuring sponsor engagement.The ideal candidate will have a strong understanding of trial execution, experience in clinical...
-
Senior Clinical Trial Manager
1 month ago
Plainsboro, New Jersey, United States Genmab Full timeAbout the RoleWe are seeking a highly skilled and experienced Senior Clinical Trial Manager to join our team at Genmab. As a key member of our Clinical Operations department, you will be responsible for delivering key trial management elements on oncology trials and ensuring sponsor engagement.Key ResponsibilitiesOperational Planning: Develop operational...
-
Clinical Trial Manager
1 month ago
Plainsboro, New Jersey, United States Genmab Full timeAbout the RoleWe are seeking a highly skilled and experienced Senior Clinical Trial Manager to join our team at Genmab. As a key member of our Clinical Operations department, you will be responsible for delivering key trial management elements on oncology trials and ensuring sponsor engagement.Key ResponsibilitiesOperational Planning: Develop operational...
-
Clinical Trial Participant
3 days ago
Plainsboro, New Jersey, United States Good Lab Full timeOpportunity to Participate in Clinical TrialsAt Good Lab, we are seeking individuals to participate in clinical trials for various mental and physical conditions. As a participant, you will have the opportunity to contribute to the advancement of medical research while earning a competitive compensation.Eligibility: No prior experience or education is...
-
Senior Biostatistics Manager
3 weeks ago
Plainsboro, New Jersey, United States Genmab Full timeAbout the RoleWe are seeking a highly skilled Senior Statistical Manager to join our Clinical Biostatistics team at Genmab. As a key member of our team, you will play a critical role in supporting the design, execution, analysis, interpretation, and reporting of clinical trials.Key ResponsibilitiesSupport the development of clinical trials, including...
-
Senior Biostatistics Manager
2 weeks ago
Plainsboro, New Jersey, United States Genmab Full timeAbout the RoleWe are seeking a highly skilled Senior Statistical Manager to join our Clinical Biostatistics team at Genmab. As a key member of our team, you will be responsible for supporting the design, execution, analysis, interpretation, and reporting of clinical trials, as well as communicating data evidence for Clinical Research & Development and...
-
Senior Biostatistics Manager
4 weeks ago
Plainsboro, New Jersey, United States Genmab Full timeAbout the RoleWe are seeking a highly skilled Senior Statistical Manager to join our Clinical Biostatistics team at Genmab. As a key member of our team, you will play a critical role in supporting the design, execution, analysis, interpretation, and reporting of clinical trials.Key ResponsibilitiesAct as lead and main point of contact related to Statistics...
-
Senior Statistical Manager
4 weeks ago
Plainsboro, New Jersey, United States Genmab Full timeAbout the RoleWe are seeking a highly skilled Senior Statistical Manager to join our Clinical Biostatistics team at Genmab. As a key member of our team, you will play a critical role in the design, execution, analysis, interpretation, and reporting of clinical trials.Key ResponsibilitiesSupport the development of clinical trials, including statistical...
-
Senior Biostatistics Manager
3 weeks ago
Plainsboro, New Jersey, United States Genmab Full timeAbout the RoleGenmab is seeking a highly skilled Senior Statistical Manager to join our Clinical Biostatistics team. As a key member of our team, you will be responsible for supporting the design, execution, analysis, interpretation, and reporting of clinical trials, as well as communicating data evidence for Clinical Research & Development and Medical...
-
Senior Clinical Research Scientist
4 weeks ago
Plainsboro, New Jersey, United States Genmab Full timeAbout the RoleWe are seeking a highly skilled Senior Clinical Research Scientist to join our Medical Department at Genmab. As a key member of our team, you will contribute to the implementation of our global development strategy, leading or co-leading one or more clinical trials in a therapeutic area for one or more compounds in various stages of clinical...
-
Senior Clinical Research Scientist
2 days ago
Plainsboro, New Jersey, United States Genmab Full timeAbout the RoleGenmab is seeking a highly skilled and experienced Senior Clinical Research Scientist to join our Medical department. As a key member of our team, you will contribute to the implementation of our global development strategy, leading or co-leading one or more clinical trials in a therapeutic area for one or more compounds in various stages of...
-
Senior Clinical Research Scientist
3 weeks ago
Plainsboro, New Jersey, United States Genmab Full timeAbout the RoleWe are seeking a highly skilled Senior Clinical Research Scientist to join our Medical Department. As a key member of our team, you will contribute to the implementation of our global development strategy, leading or co-leading one or more clinical trials in a therapeutic area for one or more compounds in various stages of clinical...
-
Digital Product Manager for Clinical Development
4 weeks ago
Plainsboro, New Jersey, United States Genmab Full timeAbout the RoleWe are seeking a highly skilled Digital Product Manager to join our Clinical Development team at Genmab. As a key member of our team, you will be responsible for overseeing the product strategy, development, and implementation of technology products in different focus areas in Development Operations.Key ResponsibilitiesCollaborate with Business...
-
Senior Clinical Research Scientist
4 weeks ago
Plainsboro, New Jersey, United States Genmab Full timeAbout the RoleWe are seeking a highly skilled Senior Clinical Research Scientist to join our Medical Department. As a key member of our team, you will contribute to the implementation of our global development strategy, leading or co-leading clinical trials in various stages of development.Key ResponsibilitiesLead or co-lead clinical trials in a therapeutic...
-
Plainsboro, New Jersey, United States Genmab Full timeAbout the RoleWe are seeking an Associate Digital Product Manager to join our Clinical Development team at Genmab. As a key member of our team, you will be responsible for overseeing the product strategy, development, and implementation of technology products in different focus areas in Development Operations.Key ResponsibilitiesCollaborate with Business...
-
Senior Research Associate, Genomics
3 weeks ago
Plainsboro, New Jersey, United States Genmab Full timeJob Title: Senior Research Associate, GenomicsAt Genmab, we're committed to building a culture of innovation and excellence, where our team members can thrive and make a meaningful impact. We're seeking a highly motivated Senior Research Associate to join our Clinical Genomics laboratory in the Precision Medicine department, located in Princeton, NJ.About...
-
Clinical Vendor Management Director
3 weeks ago
Plainsboro, New Jersey, United States Genmab Full timeAbout the RoleWe are seeking an experienced Associate Director to join our Clinical Vendor Management team at Genmab. As a key member of our team, you will play a pivotal role in managing relationships with clinical vendors, ensuring efficient and effective trial operations.Key ResponsibilitiesCoordinate sourcing for new trials, ensuring timely and effective...
-
Clinical Vendor Management Director
2 weeks ago
Plainsboro, New Jersey, United States Genmab Full timeAbout the RoleWe are seeking an experienced Associate Director to join our Clinical Vendor Management team at Genmab. As a key member of our team, you will play a pivotal role in managing relationships with clinical vendors, ensuring efficient and effective trial operations.Key ResponsibilitiesCoordinate sourcing for new trials, ensuring timely and effective...