(Senior) Manager, External Data Quality Management

Found in: Talent DK C2 - 2 weeks ago

Copenhagen, Denmark Genmab Full time

The Role

As a (Senior) Manager in External Data Quality Management, you will hold an important role within our Clinical Data Management team. Your primary responsibility will be overseeing the quality and reconciliation of external data delivery by third-party providers such as laboratories, eCOA providers, and technology vendors. This role requires an expert understanding of integrating external data into clinical trial databases, ensuring the highest standards of data accuracy and consistency across all studies.


Responsibilities

  • Provide oversight and review of data delivered by third-party external providers, ensuring high-quality data collection and testing services on behalf of Genmab.
  • Liaise with internal stakeholders (Biomarker Operations, Data Management (DM), Data Analytics, Medical, Statistics, etc.) and external partners to streamline the data collection strategy, aligning with the trial's analysis, reporting, and exploratory research needs.
  • Develop and implement study-specific third-party data reconciliation plans in collaboration with DM CROs.
  • Oversee DM CROs for quality reconciliation of external data, ensuring seamless integration into the study database.
  • Collaborate with cross-functional teams, external vendors, and DM CROs to resolve data issues efficiently.
  • Manage third-party vendors and central labs, including performance reviews, issue resolution, and process improvement initiatives.
  • Ensure timely delivery of external data, overseeing timelines and deliverables effectively.
  • Support process improvement and knowledge sharing within the data management and external data teams.

Requirements

  • Bachelor's degree in science or a related field.
  • At least 5 years of experience in external data management, with a strong background in third-party vendor management and external data oversight.
  • Clinical data management experience within a clinical research environment (pharmaceutical, biotech, CRO), preferably including oncology trials.
  • Proficient in external data reconciliation with a comprehensive understanding of various data types, testing methodologies, and biomarker testing in oncology trials.
  • Exceptional project management and communication skills, capable of working collaboratively in a multidisciplinary setting.
  • Strong organizational, analytical, and problem-solving abilities.
  • Ability to operate independently and as part of diverse teams, thriving in a dynamic, fast-paced environment.
  • Familiarity with clinical trial data systems, EDC, and related applications is a plus.
  • In-depth knowledge of clinical trials, drug development processes, GCPs, SOPs, regulatory requirements, and Good Data Management Practices.

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.

  • (Senior) Manager, External Data Acquisition, Clinical Data Management

    Found in: Talent DK C2 - 2 weeks ago

    Copenhagen, Denmark Genmab Full time

    The Role  As a (Senior) Manager in External Data Acquisition, you will play a pivotal role within our Clinical Data Management team. Your primary responsibility will be to oversee the acquisition and integration of third-party data (e.g., laboratories, eCOA providers, technology providers, etc.) who perform testing or data collection services on behalf of...

  • Manager/Senior Manager, Biostatistics

    Found in: Talent DK C2 - 2 weeks ago

    Copenhagen, Denmark Genmab Full time

    The Role The Senior Statistical Manager supports the design, execution, analysis, interpretation, and reporting of clinical trials as well as communication of data evidence for Clinical Research & Development and Medical Affairs programs with minimal supervision. This position supports statistical aspects of business-critical and/or regulatory commitments,...

  • Senior Market Access Manager

    Found in: Talent DK C2 - 2 weeks ago

    Copenhagen, Denmark Novo Nordisk AS Full time

    Do you want to drive the planning and execution of market access strategies, payer engagements and HTA submissions in region North West Europe? Can you navigate in a network with many stakeholders and a wealth of data points while looking for the optimal solution for both internal and external parties? Do you enjoy working in cross-functional teams across...

  • Energy Data Management Consultant

    Found in: Talent DK C2 - 2 weeks ago

    Copenhagen, Denmark Epam Full time

    Description ABOUT THE ROLE Embark on a dynamic journey with EPAM as a Data Management Consultant, bringing your expertise to the forefront of the oil and gas industry. Guide clients on data best practices, OSDU data platform, and Upstream processes. Engage with clients, contribute to pre-sales, and conduct impactful training sessions. Stay...

  • Quality Management Advisor, Supply Chain Management Unit

    Found in: Talent DK C2 - 1 week ago

    Copenhagen, Denmark United Nations Population Fund Full time

    The Position: The Head of Pillar 3 – Quality Management Advisor position is located in the UNFPA Supply Chain Management Unit (SCMU). The position reports directly to the Chief, SCMU. The Head of Pillar 3 – Quality Management Advisor will work closely with other SCMU colleagues, Office of the Executive Director, other HQ Business Units, the Regional...

  • Data Manager Analytics

    Found in: Talent DK C2 - 2 weeks ago

    Copenhagen, Denmark Publicis Sapient Full time

    Job Description We are seeking a Data Manager Analytics, with excellent strategic, analytical, technical, stakeholder management, communication and presentation skills, who is eager to share in the successes of a small, dedicated, growth-driven team. As part of our evolving Data & Insights practice, you will be working closely with internally- and...

  • Interim Senior Analytics Manager

    Found in: Talent DK C2 - 2 weeks ago

    Copenhagen, Denmark Kitab Sawti Full time

    At Storytel we believe that powerful stories add an extra dimension to life. Storytel is one of the world’s leading audiobook and ebook streaming services and we offer unlimited listening to consumers in over 25 markets Our vision is to make the world a more empathetic place with great stories to be shared and enjoyed by anyone, anywhere, anytime.  We...

  • Senior Manager, QA GCP/PV

    Found in: Talent DK C2 - 2 weeks ago

    Copenhagen, Denmark Genmab Full time

    The Role & Department Are you inspired to work in a company with ambitious goals, exciting clinical development programs, and highly enthusiastic colleagues? Our vision by is that Genmab’s knock-your-socks-off “KYSO” antibody medicines will transform the lives of people with cancer and other serious diseases. Do you want to safeguard patients and...

  • Senior Director, Team Lead, Clinical Data Management

    Found in: Talent DK C2 - 3 days ago

    Copenhagen, Denmark Genmab Full time

    The Role The Director, Team Lead, Clinical 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 Director, DM will provide oversight to ensure that end-to-end data management activities are...

  • Senior Programming Associate

    Found in: Talent DK C2 - 1 week ago

    Copenhagen, Denmark Genmab Full time

    The Role & DepartmentThe Senior Programming Associate / Programming Manager supports the development of new therapies by ensuring integrity, consistency, and adherence to standards of data and produces well-structured, high quality data summaries in tables, figures, and listings for decision making.The Senior Programming Associate / Programming Manager will...

  • Senior Product Manager

    Found in: beBee S DK - 3 weeks ago

    Copenhagen, Denmark Veo Technologies Full time

    Veo is a global leader in AI-based sports camera technology. Our innovative, fully automatic camera solution enables sports teams to record matches and training sessions without a camera operator. We’re democratizing the world of sports by granting video analysis for teams on all levels—a privilege that used to be only for the few. More than 40,000 clubs...

  • Senior Product Manager

    Found in: beBee jobs DK - 2 weeks ago

    Copenhagen, Copenhagen, Denmark Veo Technologies Full time

    Veo is a global leader in AI-based sports camera technology. Our innovative, fully automatic camera solution enables sports teams to record matches and training sessions without a camera operator. We're democratizing the world of sports by granting video analysis for teams on all levels—a privilege that used to be only for the few. More than 40,000 clubs...

  • Senior Product Manager

    Found in: beBee S DK - 2 weeks ago

    Copenhagen, Denmark Veo Technologies Full time

    Veo is a global leader in AI-based sports camera technology. Our innovative, fully automatic camera solution enables sports teams to record matches and training sessions without a camera operator. We’re democratizing the world of sports by granting video analysis for teams on all levels—a privilege that used to be only for the few. More than 40,000 clubs...

  • Senior Product Manager

    Found in: beBee jobs DK - 2 weeks ago

    Copenhagen, Copenhagen, Denmark Veo Technologies ApS Full time

    Veo is a global leader in AI-based sports camera technology. Our innovative, fully automatic camera solution enables sports teams to record matches and training sessions without a camera operator. We're democratizing the world of sports by granting video analysis for teams on all levels—a privilege that used to be only for the few. More than 40,000 clubs...

  • Senior Data Scientist

    Found in: beBee jobs DK - 2 weeks ago

    Copenhagen, Copenhagen, Denmark Alice AI Full time

    What we offer: The opportunity to join as one of the first employees in a fast-growing start-up A steep learning curve by working with other highly talented people A purposeful mission that is worth working hard for Competitive compensation, incl. potential stock options Role overview: Senior Data Scientist who owns Alice's bespoke AI layer, ensuring that...

  • Senior Data Scientist

    Found in: beBee S DK - 3 weeks ago

    Copenhagen, Denmark Alice AI Full time

    What we offer:The opportunity to join as one of the first employees in a fast-growing start-upA steep learning curve by working with other highly talented peopleA purposeful mission that is worth working hard forCompetitive compensation, incl. potential stock optionsRole overview: Senior Data Scientist who owns Alice’s bespoke AI layer, ensuring that we...

  • Senior Data Scientist

    Found in: beBee S DK - 2 weeks ago

    Copenhagen, Denmark Alice AI Full time

    What we offer:The opportunity to join as one of the first employees in a fast-growing start-upA steep learning curve by working with other highly talented peopleA purposeful mission that is worth working hard forCompetitive compensation, incl. potential stock optionsRole overview: Senior Data Scientist who owns Alice’s bespoke AI layer, ensuring that we...

  • Supplier Quality Manager

    Found in: Talent DK C2 - 2 weeks ago

    Copenhagen, Denmark WSAudiology Full time

    Driven by the passion to improve quality of people’s lives, WS Audiology continues to grow as market leader in the hearing aid industry. With our commitment to increase penetration in an underserved hearing care market, we want to accelerate our business transformation in order to reach more people, more effectively. Join our team as a Supplier Quality...

  • Senior Manager, QA GCP/PV

    Found in: Talent DK C2 - 2 weeks ago

    Copenhagen, Denmark Genmab Full time

    The Role & Department Are you inspired to work in a company with ambitious goals, exciting clinical development programs, and highly enthusiastic colleagues? Our vision by is that Genmab’s knock-your-socks-off “KYSO” antibody medicines will transform the lives of people with cancer and other serious diseases. Do you want to safeguard patients and...

  • Senior Legal Advisor, Commercial

    Found in: Talent DK C2 - 2 weeks ago

    Copenhagen, Denmark UNOPS Full time

    The Legal GroupThe Legal Group (LG) advises UNOPS management, project offices, ... The Legal Group The Legal Group (LG) advises UNOPS management, project offices, regional offices and other specialized units within UNOPS on institutional, commercial, and administrative law matters. Legal Advisors at UNOPS provide legal advice in the areas of public...