Current jobs related to Manager - Trial Management - Plainsboro, New Jersey - Novo Nordisk
-
Senior Clinical Trial Manager
4 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
4 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
4 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 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
2 months 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
2 months 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 Vendor Management Director
4 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
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...
-
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 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
1 month 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...
-
Associate Director, Clinical Vendor Management
4 weeks ago
Plainsboro, New Jersey, United States Genmab Full timeAbout the RoleWe are seeking an experienced Associate Director, Clinical Vendor Management to join our team at Genmab. As a key member of our clinical operations team, you will play a pivotal role in managing relationships with clinical vendors and ensuring the efficient and effective delivery of our clinical trials.Key ResponsibilitiesCoordinate sourcing...
-
Digital Product Manager for Clinical Development
1 month 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...
-
Compliance Manager
1 week ago
Plainsboro, New Jersey, United States Sathram Corporation Full timeJob Title: Compliance ManagerAbout the Role:Sathram Corporation is seeking a highly skilled Compliance Manager to join our team. As a Compliance Manager, you will be responsible for implementing and maintaining FDA-regulated biotechnology or drug development requirements, including FDA 21 CFR Parts 11, 820, GCP, ICH, HIPPA, and CDISC standards.Key...
-
Associate Director, Digital Product Management
3 weeks ago
Plainsboro, New Jersey, United States Genmab Full timeAbout the Role:Genmab is seeking an experienced Digital Product Manager to join our Clinical Development team. As a key member of our IT & Digital team, you will be responsible for overseeing the product strategy, development, and management of technology products in different focus areas in Development Operations.Key Responsibilities:Collaborate with...
-
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...
-
Plainsboro, New Jersey, United States Genmab Full timeThe OpportunityAt Genmab, we're revolutionizing the treatment landscape for patients with cancer and other serious diseases by combining deep antibody expertise with unique methods of scientific discovery.We're at the forefront of merging deep antibody expertise with groundbreaking scientific discovery, focused on transforming patient care.Dive into the...
-
Plainsboro, New Jersey, United States Genmab Full timeAbout the RoleWe are seeking an experienced Associate Digital Product Manager to join our Clinical Development team at Genmab. As a key member of our IT & Digital team, you will play a critical role in overseeing the product strategy, development, and implementation of technology products in Clinical Development.Key ResponsibilitiesOversee the full life...
-
Digital Product Manager for Clinical Development
1 month ago
Plainsboro, New Jersey, United States Genmab Full timeJob Title: Associate Digital Product Manager, Clinical DevelopmentAbout the Role:We are seeking an Associate Digital Product Manager to join our Clinical Development team. 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...
-
Plainsboro, New Jersey, United States Genmab Full timeJob DescriptionAt Genmab, we're committed to building extraordinary futures together, by developing innovative antibody products and pioneering therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in...
-
Plainsboro, New Jersey, United States Genmab Full timeThe OpportunityAt Genmab, we're revolutionizing the treatment landscape for patients with cancer and other serious diseases by combining deep antibody expertise with unique methods of scientific discovery.We're at the forefront of merging deep antibody expertise with groundbreaking scientific discovery, focused on transforming patient care.Dive into the...
Manager - Trial Management
4 months ago
About the Department
The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing that keeps us all marching to the same beat is our patient-centered focus. At Novo Nordisk, you will help patients around the world. As their needs evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a difference?
The Position
Provides tactical leadership to staff, within the Trial Management (TM) function of North America Clinical Operations (NACO).
Takes ownership to position & deliver upon near & mid-term NACO goals, including those specifically aligned with the planning & successful delivery of studies within the clinical trial portfolio.
Relationships
Reports to a Senior Manager (or above) within North America Clinical Development (NACD).
Manages mutually beneficial relationships with external partners relevant to the design & implementation of clinical trials improvement/innovation projects for NACD & Novo Nordisk (e.g., Health Systems, Contract Research Organizations & Site Management Organizations etc.)
Manages relationships positively with multiple internal stakeholders relevant to the design & implementation of clinical trials improvement/innovation projects for NACO & Novo Nordisk (e.g., across NACD, CMR, International Operations (IO), HQ R&D, & Commercial).
Essential Functions
Drives the objective setting, prioritization & tracking within Trial Management & for indirect reportsEnsures alignment & support is in place to plan & deliver all relevant services/tasks in support of the design, planning & quality* delivery of clinical trials (including required staffing, training & processes)Develops & manages relevant budgets – including compiling, forecasting, tracking & revisingTrains, develops & engages staff as required across NACD by assuring training plans (NACD level & project level) are developed & deployed within a staff subset of NACD & for indirect reportsCross-functional leadership of assigned clinical trials within North AmericaProvides operational direction to the trial team according to agreed strategy and plan, optimizing speed, quality and budget in compliance with standard processes, policies and proceduresCollaborates with Clinical Finance & Operations to ensure the NACD trial budget is developed and managed in line with organizational expectationsLeads the activities relating to the execution of the Audit Management Plan for assigned studiesResponsible for health authority (e.g., FDA) inspection preparedness and execution Physical Requirements 10-20% overnight travel required; May be required to work company holidays and weekends. QualificationsBachelor's degree required. An advanced degree is preferredA minimum of 8 years' experience in the design, planning and conduct of GCP clinical trials; with at least 6 of those most recent years working as an employee in clinical, medical and/or regulatory in the pharmaceutical industry (Pharma/Biotech/CRO)Previous experience leading cross-function clinical trial operations teams preferredExpert in ICH-GCP principles and the application of those principles to trial design, planning & conduct of clinical trialsIn-depth knowledge & direct experience/interactions with the FDA (or equivalent regulatory authority) in relation to the design, planning & conduct of GCP clinical trialsExcellent communications skills (verbal, written, presentation) in EnglishFoundational skills in designing and implementing innovation/improvement initiatives, including the required change managementA minimum of 3 years' experience in peer-to-peer coaching/mentoring is required We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we're life changing. Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations. If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at This contact is for accommodation requests only and cannot be used to inquire about the status of applications.