Job ScopeThis position plays an integral role in the development, sourcing and maintenance of clinical data management tools, database, and software for in vitro diagnostic products. The role involves activities related to ensuring the overall accuracy and integrity of clinical studies data in accordance with applicable global regulations and standards (e.g. 21 CFR Part 812, CLSI, ICH) that demonstrate the performance and utility of in vitro diagnostic products.
Key Duties and Responsibilities- Ensure the overall accuracy and integrity of the Clinical Affairs study databases.
- Implementing administrative procedures and policies to support database system use.
- Maintaining user access to the system and providing initial database training for new users.
- Entering new studies into the database and validating new study databases before clinical inputs are performed.
- Leading database users in preparing reports, tabulations, CRF preparation and database troubleshooting.
- Manage the development of primary and validation programming and lead the report generation activity for clinical trials.
- Possessing knowledge of domestic and international clinical requirements including GCP and is able to perform these essential duties and responsibilities with some direct supervision.
- Working closely with external Data Management contractors, Clinical Development, Clinical Affairs, the Clinical Trial Managers, Sample Bank team, Legal department, Logistics team, and Marketing teams to ensure project tasks are managed to completion.
- Ensure standards for statistical analyses are followed via statistical program validation and quality control activities.
- Provide statistical input, develop statistical analysis plan for clinical study protocols.
- Manage data management project timelines and schedules for projects within and outside the department.
- Select, validate, manage database for clinical data tracking (EDC system)
- Responsible for monitoring assigned clinical and outcomes studies to ensure compliance with clinical study protocols, investigator agreements, and applicable corporate regulatory requirements.
- Other job duties as assigned, which may include:
- Assist in developing departmental SOPs.
- Preparation of statistical reports for regulatory submissions, including global, FDA, IRBs or internal customers
- Preparation for departmental and executive meetings
- Clinical data entry and QC
- Case Report Form (CRF) and query management
- Select, validate, manage electronic CRF (eCRF) software/database.
- Database training for new users; support for current users
- Sample data analysis for Product Development teams.
- Benchmark study result analysis with Product Development and Marketing teams.
- Carry out internal auditing of clinical databases.
- Any other duties deemed necessary by management.
Education, Experience, and Qualifications - Bachelor's Degree with 5 years' in Molecular Biology / Biochemistry or related discipline, with experience in a regulated clinical research environment
- Master's Degree with 3 years' or Ph.D. (preferred) in Molecular Biology / Biochemistry or related discipline, with experience in a regulated clinical research environment
- Ph.D. with 1 year, in Molecular Biology / Biochemistry or related discipline, with experience in a regulated clinical research environment
- Superior communication, presentation and writing skills.
- Highly organized with proven time management and prioritization skills
- Computer programing skills for clinical data mining is desired.
- Experience in molecular and clinical data analysis.
- Experience in searching through and understanding scientific and regulatory literature.
- Experience in working independently in a fast-paced environment with rapidly changing priorities.
- Experience in documentation and record management for laboratory and clinical studies (GLP and GCP)
- Experience or knowledge of the requirements on working in a FDA regulated environment.
Travel RequirementsWhat we offerReceive a competitive salary and benefits package as you grow your career at DiaSorin. Join our team and discover how your work can impact the lives of people all over the world.
