Genmab is an international biotechnology company specializing in the creation and development of differentiated human antibody therapeutics for the treatment of cancer.
We are looking for a highly motivated and experienced Data Managers and Senior Data Managers with minimum 3- 5 years’ experience from the Pharmaceutical Industry, to be part of Global Clinical Operations at the Headquarters in Copenhagen.
As Data Manager you will be responsible for proactively ensuring planning and execution of Data Management activities on Genmab trials. You will be a key player in data cleaning activities as well as during data quality review/data trending meetings.
You will in close collaboration with our DM vendor be overall accountable for all DM activities and deliverables e.g. development of the data management plan, eCRF, data cleaning and database lock process to ensure high quality data on our trials. As Data Manager you will perform oversight of our DM vendor and support optimization of processes and tools to support further development of our department
This is a newly established position and you will be reporting to the Senior Director, Clinical Operations. As Data Manager, you will work closely with the Clinical Management Team. Your key responsibilities:
- Serve as Project Manager for DM activities across one or more trials
- Provide input to trial design and protocol
- Planning and execution of sponsor UAT
- Review and approval of DM key deliverables e.g. data cleaning plan
- Accountable for all DM deliverables within agreed timeline
- Ensure oversight of DM vendor deliverables to secure compliance with protocol, ICH-GCP and SOPs
- Maintain a close collaboration with key stakeholders, such as clinical trial managers, medical directors, clinical research scientists and biostatisticians
- Identify and mitigate trials and project related risks continuously
- Ensure data transfer specifications are finalized with all data providers
- Review of DM vendor work orders and ensure budget follow up for DM activities
- Active participation in process improvements, including SOP writing, review etc.
- QC of DM documentation
- A minimum of 3-5 years’ experience as a Data Manager within the pharmaceutical industry or a CRO
- Project Management skills
- Solid knowledge of CDISC (CDASH, SDTM)
- Basic SAS Knowledge is an advantage
- In depth knowledge of drug development processes
- Extensive hands on with clinical data management practices preferably within oncology
- Experience conducting and securing oversight of trials and /or projects within oncology is an advantage
- Knowledge of medical terminology, preferably within oncology
- Knowledge of science or a scientific background is preferred.
- Good oral and written English communication skills are mandatory
- Ability to work across all trial phases and priorities own tasks
- Dedicated team player and a great communicator with excellent social skills
- Proactive and open minded
- You have a quality mind-set and are able to prioritize your work in a fast paced and changing environment
- You are result- and goal-oriented and committed to contributing to the overall success of Genmab
At Genmab we strive to improve the lives of cancer patients by creating and developing innovative antibody therapeutics. With two marketed products and a robust pipeline of differentiated antibodies, Genmab is working to transform the treatment of cancer.
We are motivated by knowing that our work has the potential to make a real difference for cancer patients and their families. Our culture values innovation, determination, teamwork, and integrity. We work cross-functionally and internationally as one global team, while individuals and local teams have the autonomy to drive the development of innovative products and technologies that could provide next generation cancer treatments. Please refer to our homepage www.genmab.com/careers for more information about working at Genmab.
How to apply
Please mark your application “ Data Manager” and send it to email@example.com . For more information on this vacancy, please contact Hanne Beirholm tel. 29 44 00 80.
Interviews will be conducted on an ongoing basis, so please don´t hesitate to apply.