Represents the Data Management Department on clinical project teams and manages the data management aspects
of clinical projects. Ensures accurate and consistent handling of clinical data, as well as ensuring that data
management tasks are conducted according to applicable SOPs and GCP guidelines. The Sr. Clinical Data Associate may be the data management representative on more than one Clinical Project Team and provides guidance and direction to Project Team Members.
Key Job Responsibilities
Knowledge, Skills, Competencies, Education, and Experience
- Responsible for reviewing protocols for clinical trials.
- Complies with enforced standards from FDA and coordinates related parties.
- Keeps milestones in the timeline of the project, including assuring databases are locked on time.
- Liaises with vendors and cross functional teams to ensure development of database, data entry screens, and edit check programs. Manages user acceptance testing of databases and software.
- Assists in data acquisition from external sources, e.g. central laboratories and CROs.
- Provides input for Case Report Form Development.
- Performs Database Setup activities for Electronic Data Capture or eSource trials.
- Performs Data Cleaning activities for Electronic Data Capture or eSource trials. Proactively identifies and implements opportunities for process improvement.
- Performs Database Lock and snapshot lock activities Electronic Data Capture or eSource trials.
- Manages vendors according to the protocol, troubleshoots vendor accuracy and competence.
- Liaises with Clinical Data Analysts for review and completion of SDTM annotated Case Report Form (aCRF).
- Review JReview listings as per Data Validation Specification and Integrated Data Review Plan
- Functions as Data Management representative on clinical project teams.
- Provides progress reports and data reports to the team. Provides data management expertise to the team to illustrate potential issues and offers proactive solutions.
- Makes presentations at in-house, regional CRA, and/or Investigator's meetings to ensure understanding of data management issues.
- Participate in Tables and Listing review meetings as Data Management representative.
- Liaises with CRAs and Monitors to provide information on all study management issues.
- Provides input in the development of departmental standards and operating procedures.
- Ensures all activities are conducted under applicable GCP and regulatory guidelines. Ensures compliance with corporate and departmental SOPs.
- Working knowledge of the pharmaceutical industry and an understanding of protocols and scientific terminology.
- Basic knowledge on CDISC standards
- Strong computer skills with demonstrated experience in working with databases.
- Knows how/when to apply organizational policy or procedures to a variety of situations.
- Bachelor's degree in a scientific field with a minimum of 6 years of pharmaceutical industry experience in data
cleaning/review in clinical trials or 9 years of data management experience.
List Level: Individual Contributor
(See the competencies chart for core competencies
This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to their protected veteran or disabled status, or any protected status.Statement Regarding Job Recruiting Fraud Scams
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