Associate Director, Clinical Data Management

4 days ago

Plainsboro Township, United States Lifelancer Full time
Job DescriptionJob Description

Job Title: Associate Director, Clinical Data Management

Job Location: Plainsboro Township, NJ, USA

Job Location Type: Remote

Job Contract Type: Full-time

Job Seniority Level: Director

At Genmab, we’re committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off 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 science, we believe that being proudly unique, determined to be our best, and authentic is essential to fulfilling our purpose.

The Role

An Associate Director, Data Management is operationally responsible for the oversight of Clinical Data Management activities related to the effective planning, and timely delivery of complete, high quality and reliable clinical trial data. The Associate Director DM will provide oversight to ensure end-to-end data management consistency across the portfolio. The employee will also provide input to Genmab clinical drug development programs to ensure data management excellence.

Responsibilities

  • Contributes to and implements the strategic direction of the Clinical Data Management functional area
  • Contributes to the overall strategy, unified objectives and areas for development of Clinical Operations
  • Ensures data management activities and processes support the efficient and effective execution of clinical trials.
  • Ensures trial related data management activities (including planning, data collection, data cleaning and database lock activities) are performed in accordance with Genmab SOP/processes and standards and ICH-GCP
  • Provides oversight of DM CRO including Statement of Work, budget, KPIs, and performs other DM CRO oversight activities
  • Leads/contributes to standardization activities across the portfolio.
  • Drives/contributes to the development of systems and processes within Data Management
  • Ensures end-to-end data management consistency across the portfolio
  • Contributes to vendor selection; ensures collaboration and oversight of vendors related to data management activities
  • Drives/supports vendor qualification (Request for proposal, bid defense meetings etc.) for data management related activities and defines/specifies scope of work for functional tasks
  • Establishes relevant processes to ensure oversight of data management vendor partners
  • Participates in audits and inspections, as applicable
  • Ensures timely response to audits/inspections including carrying out a comprehensive root cause analysis and share learnings across trials as applicable
  • Develops and maintains advanced competences within Data Management. Follows scientific, process and technical progress within the field of clinical data management and advises of new methodologies that may support innovation and improve efficiencies
  • Proactively engages in department activities
  • Arranges lessons learned to share learnings
  • Leads/participates in various initiatives within the department and across departments
  • Proactively contributes to support a global organization

Requirements

  • Bachelor's degree in science or related area (or equivalent)
  • 10+ years of experience in clinical data management experience in biotech/ pharma industry; significant hands-on experience in all aspects of data management.
  • Experience within all phases of clinical trials.
  • Experience with clinical trials and the drug development process
  • Significant experience leading data management activities in clinical trials; advanced use of data management systems; advanced knowledge of DM processes, tools, methodologies and documentation; advanced understanding of DM strategy
  • Experience with CDISC (SDTM); as well as data collection requirements in clinical trial
  • Experience and understanding of the complex and interdependent relationships between protocol development, data collection, data review and cleaning activities and analysis and reporting in clinical trials
  • Experience and understanding of GCPs, SOPs, regulatory requirements and good data management practices
  • Experience working on early and late-stage submissions as per local/regulatory requirements
  • Experience working in and leading cross-functional teams

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

$142,500.00---$237,500.00

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.

About You

  • You are passionate about our purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatment
  • You bring rigor and excellence to all that you do. You are a fierce believer in our rooted-in-science approach to problem-solving
  • You are a generous collaborator who can work in teams with diverse backgrounds
  • You are determined to do and be your best and take pride in enabling the best work of others on the team
  • You are not afraid to 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 leverages the effectiveness of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are designed as open, community-based spaces that work to connect employees while being immersed in our state-of-the-art laboratories. Whether you’re in one of our collaboratively designed 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 guiding its unstoppable team to strive towards improving the lives of patients through innovative and differentiated antibody therapeutics. For more than 20 years, its passionate, innovative and collaborative team has invented next-generation antibody technology platforms and leveraged translational research and data sciences, which has resulted in a proprietary pipeline including bispecific T-cell engagers, next-generation immune checkpoint modulators, effector function enhanced antibodies and antibody-drug conjugates. To help develop and deliver novel antibody therapies to patients, Genmab has formed 20+ strategic partnerships with biotechnology and pharmaceutical companies. 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 locations in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and Tokyo, Japan.

Our commitment to diversity, equity, and inclusion

We are committed to fostering workplace diversity at all levels of the company and we believe it is essential for our continued success. No applicant shall be discriminated against or treated unfairly because of their race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, or genetic information. Learn more about our commitments on our website.

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.

Lifelancer ( https://lifelancer.com ) is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains.

For more details and to find similar roles, please check out the below Lifelancer link.

https://lifelancer.com/jobs/view/13c929a3b2e1192fb11fdac811491961

Apply on Lifelancer Platform

  • Associate Director

    3 days ago

    Plainsboro Township, United States Novo Nordisk Pharma Full time

    About the Department The Finance, Insights & Enterprise Solutions department brings insights and intelligence to inform decision making & drives digitalization and business solutions to attain NNI goals. Finance, Insights & Enterprise Solutions works closely across the organization to guide enterprise-wide resource allocations, investment choices, drive...

  • Chief Data Management Director

    6 days ago

    Plainsboro, New Jersey, United States Lifelancer Full time

    About Us">Lifelancer is a dynamic talent-hiring platform connecting professionals with opportunities in pharma, biotech, health sciences, and IT domains. Our commitment to diversity and equity drives our workplace culture.We strive to foster a collaborative environment where employees can thrive and make meaningful contributions. At Lifelancer, we prioritize...

  • Associate Director

    3 hours ago

    Plainsboro, NJ, United States Novo Nordisk Pharma Full time

    About the Department The Finance, Insights & Enterprise Solutions department brings insights and intelligence to inform decision making & drives digitalization and business solutions to attain NNI goals. Finance, Insights & Enterprise Solutions works closely across the organization to guide enterprise-wide resource allocations, investment choices, drive...

  • International Medical Director

    1 week ago

    Plainsboro Township, United States Novo Nordisk Full time

    Novo Nordisk International Medical Director Plainsboro, New Jersey Apply NowOur East Coast Global Development Hub brings together the best minds in life science innovation with facilities in Lexington, MA and Plainsboro, NJ. Our Liver Disease department pioneers development of treatments for MASH and ALD and oversees a robust pipeline of projects from early...

  • Clinical Research Director

    7 days ago

    Plainsboro, New Jersey, United States Novo Nordisk Full time

    About the PositionThe International Medical Director serves as a subject matter expert for our products and related data within a therapeutic area. This is an exciting opportunity to join our Liver Disease team and contribute to the development of innovative treatments for patients with liver diseases.In this role, you will work across different functional...

  • Associate Director, Clinical Development

    4 days ago

    Branchburg Township, United States Allergan Aesthetics Full time

    Job DescriptionJob DescriptionCompany DescriptionAbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and...

  • Associate Director/Director AR&D

    4 days ago

    South Brunswick Township, United States Tris Pharma Full time

    Monmouth Junction, NJDescriptionAssociate Director/Director, Analytical Research and DevelopmentMonmouth Junction, NJ • Analytical Development, R&DDescriptionTris Pharma, Inc. (www.trispharma.com) is a leading privately-owned biopharmaceutical company in the U.S. with a focus on development and commercialization of innovative medicines that address unmet...

  • Clinical Director

    2 days ago

    Freehold Township, United States SimplyApply Full time

    Clinical Director (BCBA) - ABA Centers of New JerseyFreehold, NJ $5,000 bonus for referring BCBAs to work in MA, NH, FL, TN, PA, NJ, DE, GA, TX, VA, RI About ABA Centers of New JerseyAs New Jersey's top ABA provider, we take it as our responsibility to bring the best autism therapy to as many families as possible. Applied Behavior Analysis (ABA) therapy is...

  • Senior Director

    3 days ago

    Plainsboro Township, United States Novo Nordisk Pharma Full time

    About the Department                                                                                                                                                The Clinical, Medical and Regulatory (CMR) department...

  • Data Analyst Manager

    3 days ago

    Plainsboro, New Jersey, United States Novo Nordisk AS Full time

    Job DescriptionAs a Data Analyst Manager at Novo Nordisk A/S, you will play a crucial role in providing on-going analytics support through data driven insight generation to support future pipeline therapeutic areas in the US. These include Alzheimer's Disease, Chronic Kidney Disease, Cardiovascular Disease, and others.Your key responsibilities will include...

  • Clinical Nurse II Procedural

    1 week ago

    Plainsboro Township, United States Penn Medicine Full time

    **Description**Penn Medicine is dedicated to our tripartite mission of providing the highest level of care to patients, conducting innovative research, and educating future leaders in the field of medicine. Working for this leading academic medical center means collaboration with top clinical, technical and business professionals across all disciplines.Today...

  • Senior Director

    2 hours ago

    Plainsboro, NJ, United States Novo Nordisk Pharma Full time

    About the Department                                                                                                                                                The Clinical, Medical and Regulatory (CMR) department...

  • Associate Executive Director

    3 days ago

    West Bloomfield Township, United States Waltonwood Senior Living Full time

    Job Title: Associate Executive DirectorPosition Summary: The Associate Executive Director is a position in which high potential associatesparticipate in an extensive training in order to be prepared to be a strong Executive Director for ourcommunities. This position consists of three main phases: departmental training, goal setting andcompletion, and applied...

  • Clinical Operations Director

    7 days ago

    Voorhees Township, United States Kaleidoscope ABA Therapy Services Full time

    Job SummaryKaleidoscope ABA Therapy Services is seeking a highly skilled Clinical Operations Director to oversee the day-to-day operations of our center. The ideal candidate will have 5 years of management experience in a professional environment, preferably in medical or behavioral health.Key ResponsibilitiesManage staff and services, including recruitment,...

  • Clinical Director

    2 days ago

    Mount Laurel Township, United States SimplyApply Full time

    Clinical Director (BCBA) - ABA Centers of New JerseyMount Laurel, NJ $5,000 bonus for referring BCBAs to work in MA, NH, FL, TN, PA, NJ, DE, GA, TX, VA, RI About ABA Centers of New JerseyAs New Jersey's top ABA provider, we take it as our responsibility to bring the best autism therapy to as many families as possible. Applied Behavior Analysis (ABA) therapy...

  • Nursing Director RN

    2 days ago

    Fairfield Township, United States Sunrise Senior Living Full time

    Sunrise Senior Living was again certified as a Great Place to Work® by Activated Insights. This is the 7th time Sunrise has received this top culture and workplace designation, highlighting the special place Sunrise is to be a part of. COMMUNITY NAME Sunrise of West Essex Job ID JOB OVERVIEW TheResident Care Director (RCD)/Nursing Directorserves as the...

  • Nursing Director RN

    2 days ago

    Fairfield Township, United States Sunrise Senior Living Full time

    Sunrise Senior Living was again certified as a Great Place to Work® by Activated Insights. This is the 7th time Sunrise has received this top culture and workplace designation, highlighting the special place Sunrise is to be a part of. COMMUNITY NAME Sunrise of West Essex Job ID JOB OVERVIEW TheResident Care Director (RCD)/Nursing Directorserves as the...

  • Senior Director, Strategic Planning

    2 days ago

    Plainsboro Township, United States Genmab in Full time

    Senior Director, Strategic Planning & Effectiveness – US Market (Finance)At Genmab, we're committed to building extraordinary futures together by developing 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...

  • Clinic Director

    4 days ago

    Charter Township of Clinton, United States Ellie Mental Health - 119 Full time

    Job DescriptionJob DescriptionBenefits:401(k)Bonus based on performanceCompany partiesCompetitive salaryDental insuranceFlexible scheduleFree food & snacksHealth insuranceOpportunity for advancementPaid time offParental leaveTraining & developmentVision insuranceWellness resourcesJoin Our Team in Clinton Township!Are you a dynamic, driven leader with a...

  • Director, US Medical Affairs Solid Tumors Strategy

    1 week ago

    Plainsboro, United States Genmab Full time

    At Genmab, we're committed to building extra not ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off 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...