Job Description
ITM is a privately owned biotechnology and radiopharmaceutical group of companies dedicated to the development, production and global supply of targeted diagnostic and therapeutic radiopharmaceuticals and radioisotopes for use in cancer treatment. We are developing a proprietary portfolio and growing pipeline of targeted treatments in various stages of clinical development addressing cancers such as neuroendocrine cancers or bone metastases. Our main objectives are to significantly improve treatment outcomes and quality of life for cancer patients through a new generation of Targeted Radionuclide Therapies in Precision Oncology. The headquarters are located in the heart of the research center of the Technical University of Munich (TUM).
We would like to fill the following permanent vacancy in a remote-based or hybrid working model in Garching as soon as possible
Data Management Lead (f/m/d)
- Provide oversight to CRO data management activities
- Work closely with Clinical Trial Managers, develop timelines and ensure data management objectives are met
- Develop, define, and manage data management related timelines, deliverables, and performance metrics with ITM study team and external vendors
- Participate in study planning and initiate data management start-up activities (e.g. eCRF design, edit check specification, user acceptance testing) in conjunction with the clinical study team
- Develop and revise the Data Management Plan ensuring input and approval from relevant functions
- Ensure the databases are designed in a standard, accurate, complete and consistent format conducive to analysis by working with the lead CRO data manager
- Monitor data transferred from external vendors into the clinical database for integrity, clarity, and consistency; ensure application of a consistent process for transfer and quality check
- Analyse the results from quality control activities to ensure that data quality is not put at risk and apply remediation activities if required
- Contribute to all other ITM initiatives within the Data Management team, such as SOP development, data warehouse etc.
- Multiple years' experience as a Data Manager in a CRO or pharmaceutical / biotech company, and experience as a lead CDM, managing studies through the various stages of a clinical trial
- Ability to work independently with minimal supervision and excellent written and oral communication skills are required
- Knowledge of all relevant regulations including GCP as well as general knowledge of industry practices and standards (CDISC, SDTM)
- Good understanding of clinical trial methodology, clinical trial data and databases
- Fluent in English, both written and spoken
- A team player with a keen eye for detail and quality-focused
- Exciting challenges in an up-and-coming and fast-growing company with a high degree of creative freedom
- An open working atmosphere in an international corporate culture with short communication channels
- Comprehensive onboarding programme
- Flexible working hours with home office options
- Attractive special payments
- Just a good salary? Not with us! We also offer you:
- Employee participation programme
- Job bike or subsidised job ticket
- Above-average contribution to the company pension scheme
- Individually tailored further training programme (including German and English courses)
- Health promotion programmes (e.g. subsidy for local fitness studio, sponsorship of sporting events, various lifestyle coaching sessions)