Description
An exciting Oncology focused Pharmaceutical company located in the San Jose area is in search of a contract to hire Senior Clinical Data Manager to join the team!Responsibilities include:
- Review and provide input from data management perspective on protocols.
- Work in conjunction with Clinical Project Manager on CRF design process utilizing data form standards.
- In collaboration with Clinical, create CRF completion guidelines to be utilized by sites and clinical research associates.
- Work with Database Programmer Analysts to set up, validate and maintain clinical databases in accordance with standards.
- Work with Database Programmer Analysts to develop edit checks.
- Perform user acceptance testing (UAT) of database.
- Manage access to the database by completing access revocation request forms and forwarding them to appropriate database personnel.
- Prepare and present CRF and CRF completion guidelines at investigator meetings.
- Ensure quality data management activities - i.e., data review, query generation and resolution, generate status reports to clinical staff and management.
- Ensure that Data Coordinators complete entry in a timely fashion.
- Create and maintain Data Management Plans, including, but not limited to: CRF/DCF flow, external data handling, SAE processing, coding, lock procedures, and archival procedures, collaborating with Clinical.
- Create and maintain tools for tracking and inventory of CRFs and DCFs.
- Develop guidelines for data entry.
- Generate queries to resolve data issues and apply corrections to database, working with the clinical research associate.
- Perform reconciliation of adverse events with serious adverse events database according to established guidelines.
- Perform coding of medical data using industry standard dictionaries such as MedDRA, WHO Drug, etc.
- Process laboratory data, including laboratory normal reference ranges, from local, central, or external labs according to established guidelines.
- Understand the fundamentals of merging external data with the CRF data.
Qualifications:
- Bachelor's level degree or equivalent in health/science related field.
- The ideal candidate will have 2-5 years of experience in clinical data management; preferably 3 year in device or pharmaceutical clinical trials.
- Strong computer skills including EDC is required.
- Familiarity with clinical trial design and analysis issues.
If this sounds like a good fit for you, apply and I will be in touch with more details on the role.
To find out more about Real please visit www.realstaffing.com