Senior Director, Team Lead, Clinical Data Management
3 weken geleden
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 consistent across the portfolio. The employee will also provide input to/support Genmab clinical drug development programs to ensure data management excellence.
In the role of Team Lead, the employee will be responsible for managing, coordinating, developing, supervising and supporting the employees in Clinical Data Management and ensure that the employees competencies reflect their responsibilities, as outlined in their job descriptions. The Team Lead will be part of the Data Management Leadership Team which defines the overall strategy, unified objectives, and areas for development of Data Management.
Responsibilities
Compound(s) oversight of a team of trial data managers to ensure successful delivery of DM deliverables to meet company objectives
Contributes to and drives the strategic direction of the Clinical Data Management functional area
Contributes to the overall strategy, unified objectives, and areas for development of Development Operations
Ensures data management activities and processes support the efficient and effective execution of clinical trials
Drives development of systems and processes within Data Management
Ensures end-to-end data management consistency across the portfolio
Responsible for driving the selection, collaboration and oversight of vendors related to data management activities
Establishes relevant processes to ensure oversight of data management vendor partners
Develops and maintains expert competences within Data Management
Acts as a role model
Proactively engages in department activities
Arranges lessons learned to share learnings
Leads various initiatives within the department and across departments
Proactively contributes to support a global organization
Acts as mentor for junior/new employees or consultant
Participates in audits and inspections, as applicable
Requirements
Bachelor's degree in science or related area (or equivalent); Master’s or Advanced Degree preferred
12+ years of experience in clinical data management experience in biotech/ pharma industry; significant end-to-end, hands-on experience in all aspects of data management. Experience within all phases of oncology trials preferred.
Significant experience working with clinical trials and the drug development process
Significant experience and understanding of the complex and interdependent relationships between protocol development, data collection, data review and cleaning activities and analysis and reporting in complex oncology trials
Significant experience working on early and late-stage submissions as per local/regulatory requirements
Significant experience leading data management activities for clinical trials; advanced use of data management systems; expert knowledge of DM processes, tools, methodologies and documentation; expert understanding of DM strategy
Significant experience of GCPs, SOPs, regulatory requirements and good data management practices
Significant experience working on early and late-stage submissions as per local/regulatory requirements
Significant experience in working with Clinical Data Standards in clinical oncology trials according to regulatory requirements (FDA, ICH)
Significant experience with CDISC (SDTM) as well as data collection requirements in oncology trials
Significant experience in working with and leading cross-functional teams
Experience leading/guiding/mentoring a functional team
Experience in budget management
Direct experience with EMA, FDA, and PMDA inspections preferred
The role is located in Copenhagen DK, or Utrecht NL or US (Remote)
For US based candidates, the proposed salary band for this position is as follows:
$0,00---$0,00The 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.
-
Senior Director, Head of Clinical Oversight
4 weken geleden
Utrecht, Nederland Genmab VoltijdThe Role & Department Genmab is seeking a Senior Director for the role of Head of Clinical Oversight. This leadership role will be at the forefront of establishing strategic vision and supervising the comprehensive management of clinical oversight functions across development operations. The scope may include and is not limited to, ensuring excellence in...
-
Associate Director, Clinical Data Management Standards
4 weken geleden
Utrecht, Nederland Genmab VoltijdThe Role & DepartmentThe Associate Director, Standards & Systems is operationally responsible for the development, maintenance and adherence to Genmab’s clinical data standards including eCRFs, edit checks, controlled terminology, CDASH and SDTM mapping and etc. The role provides leadership for the continued development and enforcement of data standards...
-
Utrecht, Nederland Genmab VoltijdThe 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...
-
(Senior) Manager, Clinical Trial Planning
4 weken geleden
Utrecht, Nederland Genmab VoltijdAt 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...
-
Director, Team Lead, Inspection Readiness
3 weken geleden
Utrecht, Nederland Genmab VoltijdThe Role & Department As the inaugural leader of Genmab's clinical Inspection Readiness function, you will be instrumental in cultivating an international team committed to achieving superior inspection readiness across our clinical trials. Your mission will be to oversee the readiness of clinical trial procedures and documents for regulatory scrutiny,...
-
Director, Global Medical Affairs Strategy
4 weken geleden
Utrecht, Nederland Genmab VoltijdThe Role The Genmab pipeline comprises of robust and diverse antibody products in immuno-oncology and beyond. Reporting to the Global Medical Affairs Strategy Lead (MASL) the Director will be responsible for the development and execution of the Global Medical Affairs strategic and tactical plans for the asset(s) for the primary indication as well as new...
-
Medical Director
4 weken geleden
Utrecht, Nederland Genmab VoltijdThe Role & Department Genmab continues to grow and is currently seeking a Medical Director to join our Medical Solid Tumor Team, focusing on early development/First-in-human trials.As Medical Director at Genmab, you will be accountable for the medical oversight of one or more clinical trials, medical review and communication of data, and medical input into...
-
Senior Statistician
3 weken geleden
Utrecht, Nederland Merus Netherlands VoltijdMerus is seeking a Senior/Principal Biostatistician with a robust background in statistics and relevant experience in clinical trials to join our team. To be based within our dynamic biostatistics function, you will be reporting to a Senior Director of Biostatistics. This position significantly impacts our clinical development activities, including leading...
-
Senior Manager, QA GCP/PV
4 weken geleden
Utrecht, Nederland Genmab VoltijdThe 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...
-
Director, Program Management, Translational
3 weken geleden
Utrecht, Nederland Genmab VoltijdAt 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...
-
(Associate) Director, Biostatistician
4 weken geleden
Utrecht, Nederland Genmab VoltijdAt 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...
-
Senior Manager, QA GCP/PV
4 weken geleden
Utrecht, Nederland Genmab VoltijdThe 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 Java Developer
2 weken geleden
Utrecht, Nederland Sogeti VoltijdAls Senior Java Developer / Team lead bij Sogeti ben je onderdeel van onze toonaangevende best-gecertificeerde Java community. Deze bestaat uit ruim 100 gepassioneerde professionals, waarbij er in teamverband mooieprestaties worden geleverd. Daarmee draag je aan bij de meerwaarde die wij leveren aan onze top-opdrachtgevers. Geen werkdag is hetzelfde! Je...
-
Senior Project Executive, Site Management
4 weken geleden
Utrecht, Nederland HKU VoltijdSenior Project Executive, Site Management (at the rank of Technical Officer) in the Clinical Trials Centre (Ref: 524154) The Clinical Trials Centre (HKU-CTC) is a leading clinical trials management platform established under The University of Hong Kong LKS Faculty of Medicine (HKUMed) and is dedicated to managing and facilitating international-standard...
-
Data Analyst
4 weken geleden
Utrecht, Nederland HKU VoltijdData Analyst (at the rank/grade of Technical Officer/Research Assistant I/II) in the Clinical Trials Centre (Ref: 524146) The Clinical Trials Centre (HKU-CTC) is a leading clinical trials management platform established under the LKS Faculty of Medicine and dedicated to managing and facilitating international-standard clinical trials on new drugs,...
-
Senior Director, Regulatory Affairs Strategy-EU/RoW
3 weken geleden
Utrecht, Nederland Genmab VoltijdThe Role & DepartmentAs a Senior Director, you will join our Global Regulatory Affairs organization. In this capacity, you will assume responsibility for the EU/ROW regulatory strategy for an assigned program and will manage a group of Regulatory Strategists with EU/ROW responsibilities for our programs across all stages of development. The chosen candidate...
-
Director, Biostatistics
3 weken geleden
Utrecht, Nederland Genmab VoltijdThe Role :The Director acts as a statistical expert supporting the clinical development of compounds as compound and/or indication lead for both early and late-stage programs, and/or as trial responsible statistician with responsibilities as described below. The Director contributes to clinical development strategies and plans. This opportunity will be...
-
(Senior) Legal Counsel
1 maand geleden
Utrecht, Nederland Taylor Root VoltijdOur client is a renown multinational company in the FMCG/Life Science sector with their regional Headquarters in the Randstad area in The Netherlands. They are looking for a Senior Legal Counsel with a focus on research and clinical trials to strengthen the legal department. About the role: As a Senior Legal Counsel you will be based at the research office...
-
Data Management Consultant
4 weken geleden
Utrecht, Nederland Rabobank Gruppe VoltijdJouw data management skills hebben impact op onze 9,5 miljoen klanten. Jij & jouw functie Je komt te werken in een dynamische omgeving waar jij als spin in het web opereert tussen data leveranciers en data gebruikers. Samen met je collega's ben je verantwoordelijk voor het verbeteren van de datakwaliteit en het bewust maken van jouw stakeholders van...
-
Associate Director, Translational Medicine
4 weken geleden
Utrecht, Nederland Genmab VoltijdThe Role The Associate Director, Translational Medicine (TM) is a member of the TM team, which is embedded in the global Translational Research & Precision Medicine Department. The TM team focuses on preclinical and clinical translational research to advance the clinical development of innovative and differentiated antibody therapeutics for the treatment of...