Clinical Data Associate II

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Precision Medicine Group

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2012

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 $35.2M Venture Round on 2021-03

Consulting • Healthcare • Logistics

Precision Medicine Group is a global team of experts that specializes in precision medicine, which combines advanced lab sciences, translational informatics, regulatory affairs, payer insights, and marketing communications. The company focuses on overcoming product development and commercialization challenges for pharmaceutical and life sciences clients. Their services include biomarker-driven research and development, as well as commercialization support for life science organizations from launch to product maturity. Precision Medicine Group operates through two main arms: Precision for Medicine and Precision AQ, specializing in clinical and commercial solutions respectively.

📋 Description

• Provide 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. • 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

🎯 Requirements

• Bachelor's degree and/or a combination of related experience • Around 2 years’ experience working as a Clinical Data Associate for a CRO/Pharma/Biotech company. • 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.

🏖️ Benefits

• Health insurance • Paid time off • Professional development