Clinical Data Associate/Senior Clinical Data Associate

at  Precision Medicine Group

Precision for Medicine is seeking an experienced Clinical Data Associate/Senior Clinical Data Associate to provide comprehensive data management support throughout all phases of the clinical trial data management process. Under direct supervision, you will ensure adherence to Standard Operating Procedures (SOPs), regulatory guidelines, and study-specific plans. This role encompasses a range of responsibilities, including data cleaning and reconciliations, database testing, quality control, and collaboration within a dynamic team environment.

POSITION SUMMARY:

The Clinical Data Associate/Senior Clinical Data Associate 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.

SKILLS:

• Demonstrates strong knowledge of ICH-GCP, relevant Precision Oncology SOPs, and regulatory guidance, as well as the ability to implement and drive outcomes

• Support the Lead DM as a back-up and/or team member, ensuring continuity, responsiveness,
• and that tasks are performed in a timely manner
• Perform data entry for paper-CRF studies, as needed
• Perform quality control of data entry.
• Provide input into timelines. Ensure that clinical data management deadlines are met with quality. May assess resource needs for assigned projects, as needed.
• Assist in developing CRF specifications from the clinical study protocol and coordinate the
• review/feedback from all stakeholders
• Assist in building clinical databases.
• Conduct database build UAT and maintain quality controlled database build documentation. May
• oversee overall quality of the clinical database.
• 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
• Perform 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
• Assist with SAS programming and quality control of SAS programs used in the Data Management department.
• Identify and troubleshoot operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholders.
• Assist in reviewing and providing feedback on protocols, Statistical Analysis Plans (SAP) and
• Clinical Study Reports (CSRs), if required by the project
• 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
• Trains and ensures that all data management project team members have been sufficiently trained.
• Communicate with study sponsors, vendors and project teams as needed regarding data, database or other relevant project issues.
• Present software demonstrations/trainings, department/company training sessions, present at project meetings
• Perform other duties as assigned.
  Qualifications