Job Description:

Genmab is focused on the creation and development of innovative and differentiated antibody products, with the aim of improving the lives of cancer patients.

Senior Clinical Data Manager

Genmab is an international biotechnology company specializing in the invention and development of differentiated human antibody therapeutics for the treatment of cancer and other important human diseases.

The Role

Genmab is looking for a highly motivated and experienced Senior Clinical Data Manager, with a minimum 5-10 years' experience from the Pharmaceutical industry, to be part of Clinical Data Management within Global Clinical Operations. The level of this position will reflect the experience and seniority of the candidate.

The Senior Clinical Data Manager will be responsible for proactively securing reliable, timely and high-quality clinical trial data for Genmab trials by providing clinical data management oversight of the conduct of the trials. The Senior Clinical Data Manager will provide a leadership role in the oversight of the data cleaning process as well as oversight of data quality and detection of data trends and serves as the main contact for all data management activities for Clinical Trial Teams. The Senior Clinical Data Manager provides strategic data management expertise to ensure high-quality data deliverables are achieved within timelines and budget.

You will, in close collaboration with the Biometrics Vendor partner, be accountable for all end-to-end Data Management activities and deliverables. The Senior Clinical Data Manager will provide oversight of all vendors conducting data management activities on behalf of Genmab. Further, the Senior Clinical Data Manager will support the development and optimization of processes and tools to enable success of the Clinical Operations department.

Responsibilities

In this position, you will be reporting to a Data Management Team Lead in Clinical Data Management. The Senior Clinical Data Manager will work closely with the Clinical Trial Team to ensure successful trial conduct. The key responsibilities include, but are not limited to:

• Serving as the project manager for Data Management activities across one or more trials


• Accountability for all end-to-end Data Management deliverables within the agreed timeline and budget


• Providing input to trial design and protocols


• Performing DM Vendor oversight, including the review and approval of key Data Management key documentation (Data Management Plan, Data Validation Plan, Data Transfer Specifications, etc.).


• Ensuring Data Management Vendor deliverables are performed in compliance with protocol, ICH-GCP and SOPs


• Planning and oversight of all data management activities across all phases of trial conduct. This includes working with the DM Star-up Lead to ensure the planning, oversight and execution of DM trial start-up activities. Activities include review the eCRF, leading the sponsor acceptance testing of the database/eCRF, leading the data validation strategy and ensuring data transfer specifications are developed and implemented for all data providers.


• Planning and oversight of trial data cleaning activities, including leading the data review and cleaning strategy, including the development of the Data Review & Cleaning Plan.


• Planning and oversight of database lock activities to ensure high-quality data deliverables are achieved within timelines.


• Sponsor oversight of DM vendors trial conduct using key performance indicators; oversight of data quality using key risk indicators and oversight dashboards.


• Continuously identifying and mitigating trial related risks.


• Maintaining a close collaboration with key internal stakeholders, such as DM Start-up Leads, DM External Data Leads, Clinical Trial Managers, Medical Directors, Clinical Research Scientists, Programmers and Biostatisticians.


• Reviewing Data Management vendor work orders and ensuring budget for Data Management related activities.


• Actively participating in process improvements, including SOP development, new systems implementation, defining data management best practices, etc.


• Performing quality control of Data Management documentation and e-trial master file oversight.

  Requirements
  

  
  

• The Senior Clinical Data Manager level requires a minimum of 5-10 years' experience as a clinical data manager in the pharmaceutical/CRO industry within the oncology therapeutic area.


• Leadership Skills; experience as a Project DM, Lead DM is an advantage


• Project Management skills; excellent organizational skills


• In depth knowledge of clinical trials and the drug development process


• Extensive hands-on experience with clinical data management practices within the oncology therapeutic area


• Experience conducting and securing oversight of trials and/or projects; DM vendor oversight of oncology trials an advantage


• Knowledge of medical terminology, preferably within oncology


• Knowledge of science or a scientific background is preferred


• Strong understanding of GCPs, SOPs, regulatory requirements and Good Data Management Practices


• Experience with data management systems. Experience with Rave electronic data capture system; use of Rave in oncology studies is preferred


• Solid knowledge of CDISC (CDASH, SDTM); understanding of data collection requirements in oncology trials preferred


• Experience with data visualization software for data review and trial oversight (e.g. JReview, Spotfire, Qlik Sense, etc.)


• Good oral and written communication skills

  Moreover, the following personal requirements describe you:
  

  
  

You are a dedicated and engaged team player. You easily build relationships. You are a clear and direct communicator. You have a quality mind-set. You are adaptable and able to prioritize your work in a fast paced and changing environment; you are agile and resilient. You drive performance and are a fast learner. You identify opportunities for improvement and champion best practices.

Genmab employees work with determination and with respect for each other, consistent with our core values, to achieve our common goals. We give individuals and teams the autonomy to drive development of innovative products and solutions, knowing that integrity is a core value throughout our company. Genmab will offer the successful application a challenging position, where the right candidate will have the opportunity to work with highly specialised people across functions in an informal, multicultural culture, all aiming to make a difference for cancer patients.

Teamwork and respect are central pillars of Genmab's culture and we therefore ensure an inclusive, open, and supportive professional work environment across our international locations. We believe that fostering workplace diversity across social, educational, cultural, national, age and gender lines is a prerequisite for the continued success of the company. We are committed to diversity at all levels of the company and strive to recruit employees with the right skills and competences, regardless of gender, age, ethnicity, etc.

Please note that if you are applying for a position in the Netherlands; Genmab's policy for all permanently budgeted hires in this location is to offer a temporary agreement for one year, followed by a contract for indefinite time regardless of seniority.

Genmab A/S is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with you application on our website https://www.genmab.com/privacy .

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