OSM Pharma are recruiting for a Clinical Data Manager to join an innovative biotech with a very promising lead compound approaching Phase III clinical research. This can be fully home based in the UK.
Our client is committed to develop and deliver innovative therapies to patients to address major unmet medical needs and advance cancer care. The company aspires to become a leader in the development of targeted therapies for haematological cancers.
- Review of clinical data alongside clinical and medical colleagues and support the timely completion of accurate data to support business needs and compliance.
- Lead and coordinate data export and import to and from third parties for all clinical studies and oversight of the respective third parties.
- Determine and evaluate the status of incoming data and the need for escalation to various functions.
- Report and discuss findings with senior management.
- Coordinate Data Management activities and monitor overall data quality for the clinical studies.
- Support the planning and coordination of the activities leading to the interim and final analyses across the programme.
- Input to detailed project plan, communication and coordination of activities.
- Plan and coordinate the activities with internal and external stakeholders prior to the data locks, to ensure timely completion of the database lock procedures/data cleaning.
- Provide oversight and coordinate activities with external central laboratories, working closely with bioanalytics expert and clinical/medical colleagues.
- Provide reports and SOPs as required to support the data management infrastructure.
- Participate in the preparation and execution of internal and external audits as needed.
- Ensure handling of clinical data according to rules and regulations.
- Expert knowledge of regulatory guidelines (GCP) and Good Clinical Data Management Practices.
- Proven experience as a Clinical Data Manager in a biotech or pharmaceutical company resulting in successful filing is required (preferably FDA) in an outsourced environment.
- Proven experience with a database lock procedure.
- Proven experience with development of Clinical Study reports.
- Highly experienced with the structure and technical requirements of relevant databases.
- Experience from studies within oncology is a clear advantage.
- Highly-organised, efficient and with an excellent attention to detail.
- Flexible to travel.