Clinical Data Manager
The Precision Oncology Unit (POU) at the Institute FIRC of Molecular Oncology (IFOM) is seeking a Clinical Data Manager. The POU works as the go-between of basic/translational and clinical research by designing, deploying and counducting:
- flexible master protocols to feed basic/translational researchers with annotated longitudinal clinical data and samples;
- cutting-edge proof-of-concept clinical trials designed from the grounds of basic/translational research discoveries;
POU is funded by major charities and pharma-related supportive grants and is embedded in two large consortia of multidisciplinary research in the field of colorectal and breast cancer.
The Clinical Data Manager will report directly to the POU Group leader, under the supervision of the Clinical PM and will be involved in the whole process of Data Management mainly concerning master protocols, including:
- Design, test and validate eCRFs as per established standards and applicable protocol, respecting its aims and flexibility.
- Develop and execute SOPs, guidelines and data standards to guarantee database quality control and data management according to GCP standards.
- Develop study-specific documents (e.g. DMP, DVP and DMR) and execute/coordinate remote monitoring and cleaning procedures to guarantee high data quality and develop reports.
- Liaise with POU IT Project Manager in charge of POU data integration platform.
- Coordinate with clinical sites to make sure data is collected, managed and reported clearly, accurately and securely, overseeing the workflow of inconsistencies resolution.
- Use problem solving and judgment to apply Clinical Data Management principles.
Qualifications and Skills
- Master and/or previous experience in Clinical Data Management.
- Good knowledge of GCP and data integrity principles.
- Knowledge of REDCap or similar EDC systems.
- Good IT Knowledge (Microsoft Office Pack; ability to use statistical analysis software will be preferred).
- Good oral and written communication skills in English.
- Problem solving attitude, specifically being pro-active, collaborative, critically creative and able to work independently under the pressure of deadlines.
The following are considered plus requisites
- MSc in life sciences (a PhD will be preferred).
- Comprehension of data integration and data-lakes concepts.
- Strong commitment and passion in science (as determined by CV).
Type of Contract
Contract and Salary will depend on previous experience.
Send applications to:
Precision Oncology Unit
IFOM – the FIRC Institute of Molecular Oncology
Via Adamello 16, 20139 Milano (Italy)