Clinical Data Management Lead
3 dagen geleden
The Role:
As a Manager in External Data Acquisition, you will play a pivotal role within our Clinical Data Management team at Genmab. Your primary responsibility will be to oversee the acquisition and integration of third-party data from laboratories, eCOA providers, technology providers, etc., ensuring its alignment with clinical trials' objectives and regulatory standards.
Key Responsibilities:
- Lead and provide strategic insights into protocol development, focusing on external data collection and integration.
- Standardize data type specifications to align with Electronic Data Capture (EDC) requirements and clinical trial objectives.
- Ensure data transfer processes comply with CDASH and SDTM standards, facilitating efficient data analysis and reporting.
- Develop detailed data transfer specifications for acquiring external data from third-party vendors.
- Coordinate with vendors to guarantee that data collection is compatible with clinical databases and meets SDTM requirements.
- Oversee Data Management Contract Research Organizations (DM CROs) for seamless external data transfers.
- Review and assess vendor contracts, setup specifications, and test data transfers.
- Proactively identify and resolve issues related to external data transfers throughout the trial lifecycle.
Requirements:
- Bachelor's degree in science or a related field.
- 3-5+ years of experience in clinical data management with a focus on external data in the biotech/pharma industry.
- Profound knowledge of oncology trials, EDC systems, and technical aspects of data transfer.
- Strong understanding of data management processes, tools, methodologies, and documentation.
- Familiarity with GCPs, SOPs, regulatory requirements, and good data management practices.
- Proficiency in CDISC (SDTM) standards and clinical data standards development.
- Proven project management skills.
About You:
- Passionate about Genmab's mission and driven to make a significant impact in a dynamic biotech environment.
- Exceptional technical expertise in clinical data management and external data acquisition.
- Ability to thrive in a fast-paced setting, maintaining the quality and integrity of clinical data.
Where You Will Work:
- This role is remote in the US, with US candidates required to live in the Eastern Time Zone.
- Candidates based in Copenhagen, DK, or Utrecht, the Netherlands, can work in a hybrid environment (3 days in the office, 2 remote).
The actual salary offer will carefully consider a wide range of factors, including your skills, qualifications, experience, and location. 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.
Genmab's 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.
-
Clinical Data Specialist
3 dagen geleden
Utrecht, Utrecht, Nederland HKU VoltijdHKU is seeking a highly skilled Clinical Data Specialist to join its Clinical Trials Centre. This role will be responsible for collaborating with data management specialists and biostatisticians to perform data management, analysis, and reporting duties.Main Responsibilities:Perform data management and analysis tasks using SAS/R;Design and develop Electronic...
-
Clinical Data Manager
4 weken geleden
Utrecht, Utrecht, Nederland Yacht VoltijdJoin Yacht Life Sciences as a Clinical Data ManagerWe are seeking a highly skilled Clinical Data Manager to join our Human Evidence Data Operations team in Utrecht, the Netherlands. As a Clinical Data Manager, you will play a crucial role in setting up and maintaining data collection tools, following the entire data management process, and providing best...
-
Senior Clinical Data Manager
1 week geleden
Utrecht, Utrecht, Nederland Danone VoltijdAbout the JobAs a Senior Clinical Data Manager at Danone, you will play a crucial role in managing data from electronic Patient Reported Outcome and/or medical devices in clinical trials. Reporting directly to the Senior Team Leader of Clinical Data Management, you will oversee the clinical data management process and work closely with an international,...
-
Senior Clinical Data Manager
2 weken geleden
Utrecht, Utrecht, Nederland Danone VoltijdAbout the RoleWe are seeking a Senior Clinical Data Manager to join our team in Utrecht. As a key member of our international study team, you will be responsible for overseeing the clinical data management process in clinical trials.Key ResponsibilitiesDesign and validate electronic data capture instruments, including ePRO and eCRFs.Work with Medical Device...
-
Clinical Trials Data Specialist
2 weken geleden
Utrecht, Utrecht, Nederland HKU VoltijdClinical Trials Data SpecialistThe Clinical Trials Centre (HKU-CTC) is a leading clinical trials management platform established under the LKS Faculty of Medicine. We are seeking a highly skilled Clinical Trials Data Specialist to join our team.Main Responsibilities:Develop data management plans;Design and develop Electronic Case Report Forms (eCRF), set-up...
-
Clinical Trials Data Specialist
2 weken geleden
Utrecht, Utrecht, Nederland HKU VoltijdClinical Trials Data SpecialistThe Clinical Trials Centre (HKU-CTC) is a leading clinical trials management platform established under the LKS Faculty of Medicine. We are seeking a highly skilled Clinical Trials Data Specialist to join our team.Main Responsibilities:Develop data management plans and design Electronic Case Report Forms (eCRFs).Set up study...
-
Clinical Trials Data Specialist
2 weken geleden
Utrecht, Utrecht, Nederland HKU VoltijdClinical Trials Data SpecialistThe Clinical Trials Centre (HKU-CTC) is a leading clinical trials management platform established under the LKS Faculty of Medicine. We are seeking a Clinical Trials Data Specialist to join our team.Main Responsibilities:Collaborate with a team of data management specialists and biostatisticians to perform duties related to...
-
Senior Clinical Data Manager
3 weken geleden
Utrecht, Utrecht, Nederland Danone VoltijdAbout the JobWe are seeking a highly skilled Senior Clinical Data Manager to join our team in Utrecht. As a key member of our international study team, you will be responsible for overseeing the clinical data management process in clinical trials, working closely with Medical Device and App vendors, and ensuring the quality and integrity of our data.Key...
-
Clinical Data Manager
2 weken geleden
Utrecht, Utrecht, Nederland Yacht VoltijdYacht Life Sciences is seeking a skilled Clinical Data Manager to join our team in Utrecht, the Netherlands.As a Clinical Data Manager, you will be a key member of the Human Evidence Data Operations team, responsible for setting up and maintaining data collection tools according to the Protocol. You will oversee the entire data management process until the...
-
Senior Clinical Data Manager
3 weken geleden
Utrecht, Utrecht, Nederland Danone VoltijdAbout the RoleWe are seeking a highly skilled Senior Clinical Data Manager to join our team in Utrecht. As a key member of our international, multi-disciplinary study team, you will be responsible for overseeing the clinical data management process in clinical trials, with a focus on digital health data.Key ResponsibilitiesDesign and validate electronic data...
-
Clinical Data Manager
3 weken geleden
Utrecht, Utrecht, Nederland Yacht VoltijdJob Title: Clinical Data ManagerYacht Life Sciences is seeking a highly skilled Clinical Data Manager to join our Human Evidence Data Operations team in Utrecht, the Netherlands.Job Summary:We are looking for a detail-oriented and organized individual to oversee all data management activities, ensuring the highest quality of data collection and management....
-
Senior Clinical Data Manager
4 weken geleden
Utrecht, Utrecht, Nederland Danone VoltijdAbout the JobWe are seeking a highly skilled Senior Clinical Data Manager to join our team in Utrecht. As a key member of our international, multi-disciplinary study team, you will play a central role in managing data from electronic Patient Reported Outcome (ePRO) and/or medical devices.Key ResponsibilitiesDesign and validate electronic data capture...
-
Senior Clinical Data Manager
1 maand geleden
Utrecht, Utrecht, Nederland Danone VoltijdAbout the JobWe are seeking a highly skilled Senior Clinical Data Manager to join our team in Utrecht. As a key member of our international, multi-disciplinary study team, you will play a central role in managing data from electronic Patient Reported Outcome (ePRO) and/or medical devices.ResponsibilitiesDesign and validate electronic data capture...
-
Senior Clinical Data Manager
2 weken geleden
Utrecht, Utrecht, Nederland Danone VoltijdAbout the RoleWe are seeking a highly skilled Senior Clinical Data Manager to join our team at Danone. As a key member of our international, multi-disciplinary study team, you will play a central role in managing data from electronic Patient Reported Outcome (ePRO) and/or medical devices.Key ResponsibilitiesDesign and validate electronic data capture...
-
Clinical Research Leadership Position
6 dagen geleden
Utrecht, Utrecht, Nederland Genmab VoltijdKey Role in Global Development StrategyThis position serves as a key role in the effective implementation of the global development strategy for clinical trials in various stages of development. Working closely with the Medical Director and other cross-functions, you will provide high-quality and timely deliverables.ResponsibilitiesLead or co-lead complex...
-
Clinical Research Scientist
1 maand geleden
Utrecht, Utrecht, Nederland Genmab VoltijdJob SummaryWe are seeking a highly skilled Clinical Research Scientist to join our team at Genmab. As a key member of our clinical development team, you will be responsible for leading or co-leading clinical trials within a program, working closely with Medical Directors and Sr. level Clinical Research Scientists to provide high-quality and timely...
-
Clinical Research Director
1 maand geleden
Utrecht, Utrecht, Nederland Genmab VoltijdAbout the RoleThis is a key position in 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 development. The successful candidate will work closely with the Medical Director and other cross-functions to provide high-quality and...
-
Clinical Trial Associate Team Lead
1 maand geleden
Utrecht, Utrecht, Nederland Genmab VoltijdAbout the RoleWe are seeking a highly skilled and experienced Associate Director to join our Clinical Trial Team at Genmab. As a key member of our team, you will be responsible for managing a team of Clinical Trial Associates and providing strategic leadership to drive the success of our clinical trials.Key ResponsibilitiesTeam Management: Lead and manage a...
-
Clinical Research Scientist
2 maanden geleden
Utrecht, Utrecht, Nederland Genmab VoltijdAbout the RoleWe are seeking a highly skilled Clinical Research Scientist to join our team at Genmab. As a key member of our clinical development team, you will play a critical role in the implementation of clinical trials and the development of new cancer treatments.Key ResponsibilitiesLead or co-lead clinical trials within a program, working closely with...
-
Clinical Evidence Manager Lead
3 dagen geleden
Utrecht, Utrecht, Nederland Danone VoltijdAbout the JobAs a Senior Strategic Clinical Evidence Manager at Danone, you will be part of the Global team in the Clinical Research Department, working at the heart of evidence generation for Danone's Specialized Nutrition product portfolio. Your role will involve co-building and driving strategic evidence generation programs and post-launch studies with...
