Job Description

Position Summary:

The Clinical Data Associate II provides data management support and assistance in all aspects of the clinical trial data management process from study start up to post database lock for assigned projects under direct supervision. Standard Operating Procedures / Work Instructions (SOPs/WIs); regulatory directives; study specific plans and guidelines will be followed. This position may perform database development and testing, as well as additional data management activities.

Essential functions of the job include but are not limited to:

Support the Lead DM as a back-up and/or team member, ensuring continuity, responsiveness, and that tasks are performed in a timely manner

May perform data entry for paper-CRF studies, as needed

May perform quality control of data entry

May develop CRF specifications from the clinical study protocol and coordinate the review/feedback from all stakeholders

May assist in building clinical databases

Conduct database build UAT and maintain quality controlled database build documentation

Assist in specifying requirements for all edit check types e.g. electronic, manual data review, edit checks, etc.

Responsible for creating, revising, appropriate versioning and maintaining data management documentation.

Train clinical research personnel on the study specific CRF, EDC, and other project related items as needed

Review and query clinical trial data according to the Data Management Plan

Assist in line listing data review based on the guidance provided by the sponsor and/or Lead DM

Run patient and study level status and metric reporting

Perform medical coding of medical terms relative to each other in order to ensure medical logic and consistency

Assist with coordinating SAE/AE reconciliation

Assist with liaising with third-party vendors such as external data and EDC vendors in a project-manager capacity in support of timelines and data-related deliverables

May assist with SAS programming and quality control of SAS programs used in the Data Management department

May assist in identifying and troubleshooting operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholders

May assist in reviewing and providing feedback on protocols, Statistical Analysis Plans (SAP) and Clinical Study Reports (CSRs), if required by the project

May assist in participating in the development and maintenance of Standard Operating Procedures (SOPs) and corresponding process documentation related to data management and database management activities

Communicate with study sponsors, vendors and project teams as needed regarding data, database or other relevant project issues

May present software demonstrations/trainings, department/company training sessions, present at project meetings

May require some travel

Perform other duties as assigned

Qualifications:

Minimum Required:

Bachelors and/or a combination of related experience

Other Required:

2+ years experience

Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook

Able to handle a variety of clinical research tasks

Excellent organizational and communication skills

Professional use of the English language; both written and oral

Preferred:

Experience in a clinical, scientific or healthcare discipline.

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Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. © 2020 Precision Medicine Group, LLC

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Clinical Data Associate II

Clinical Data Associate I / II