Description
Senior Clinical Data Associate is responsible for data management activities in-house as well as management of those that are outsourced to Contract Research Organizations (CROs) for one or more clinical oncology studies.Key Responsibilities/Core Job Description:
- Take part in protocol review, focusing on data management related sections and cross-study data collection consistency.
- Participate in the design, documentation, testing and implementation of clinical data collection using paper or electronic data capture systems (EDC).
- Perform or oversee all data management activities from study initiation to database lock from design of Case Report Forms (CRF/eCRF), edit check specifications, CRF completion guidelines, Data Management Plan, data listing reviews, data reconciliations, database lock activities and any other study specific task that is required.
- Responsible for data completeness and quality by performing ongoing listing reviews, various data reconciliations, review and resolution of data queries.
- Work closely with cross functional study team members from clinical operations, safety, and biostatistics to perform study tasks and achieve study goals.
- Provide metrics and study data management updates to the team.
Job Requirements:
Qualifications/Experience:
- Minimum of 5-7 years of Data Management experience
- Experience with oncology protocols
- Contract Research Organization (CRO) management experience
- Electronic Database Capture (EDC) experience
- Knowledge of RECIST criteria
- Experience with data listings review for completeness and accuracy
- Familiarity with MedDRA/Who-Drug coding
- Ability to work independently on assigned projects
- A team player, capable of building effective working relationships
- Strong verbal and written communication skills
To find out more about Real please visit www.realstaffing.com