Location: Redwood City, CA
The Associate Clinical Data Manager assists in data management activities in support of execution of clinical trials to ensure compliance with regulatory authorities, GCP, ICH and SOPs.
Works under moderate guidance and participates in the planning, set-up, conduct and closeout of databases for clinical research projects, contributing technical and clinical operations expertise.
Clinical data management duties as follows:
Works collaboratively with CRAs, Statistical Programmers, Biostatisticians and other Clinical, Regulatory and Project Management staff to meet project deliverables and timelines for clinical data acquisition, quality checking and reporting.
Demonstrates a general understanding of each assigned protocol, critical tasks and milestones.
Ensure completeness, correctness and consistency of routine clinical data and data structure.
Assists in the implementation of routine clinical data management process with vendors including data entry, data quality checking, data transfer, reporting, backup, and recovery.
Assists in the preparation of CRF/eCRF for data collection through the regulatory approval process.
Assists in implementing routine clinical research projects.
Reviews study protocol and assists site coordinators, investigators, and field clinical staff in collecting routine data to meet the protocol requirements in a timely manner. Identifies, tracks, and resolves routine queries.
Utilizes routine reports to track study progress and ensures timeliness and quality expectations are met.
Knowledge of FDA regulations, support of needs for regulatory submissions, and familiarity with web-based Electronic Data Capture (EDC) and clinical data management systems.
Develop and maintain working relationship with clinical site managers/CRAs.
Assist in development and preparation of clinical documents including data management plan, clinical monitoring plans, site operations, and data entry guides.
Lead creation and development of database creation and results analysis.
Handle all forms of correspondence and distribution, and allocation of action items in a timely
May lead centralized statistical monitoring of study data.
May research, monitor, or prepare semi-routine reports or analyses, summarize findings, and
make recommendations, to solve administrative problems.
Use computers and other standard business machines and equipment.
Other duties as assigned or requested.
QUALIFICATIONS AND EDUCATION REQUIREMENTS:
1-3 years related experience in the area of data management in pharmaceutical or medical
Basic knowledge of reading and interpreting protocol requirements documents to develop
a data collection plan.
General programming/logic knowledge
Proficiency in MS Office, particularly Excel
Working knowledge of FDA regulatory policies, procedures and requirements.
Excellent communication, interpersonal and organizational skills
Ability to collaborate in a team environment as well as work independently
Self-starter with the ability to manage multiple projects in a dynamic environment
Candidates with experience in SAS and SQL programming knowledge are highly