Precision for Medicine is an industry-leading global clinical research services organization, purpose-built to improve the clinical research and development process for current therapeutics. Our novel approach integrates clinical operations excellence, with laboratory expertise, and advanced data sciences to inform every step. This maximizes our clients’ insight into patient biology, delivering more predictable trial outcomes and accelerating clinical development. We apply our expertise to trials at all stages—from early development through approval—with embedded experience in oncology and rare disease. With over 2000 dedicated professionals and 35 offices worldwide, we stand ready to help accelerate life-changing treatments anywhere around the globe.Website:http://www.precisionformedicine.comPosition 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 mannerMay perform data entry for paper-CRF studies, as neededMay perform quality control of data entryMay develop CRF specifications from the clinical study protocol and coordinate the review/feedback from all stakeholdersMay assist in building clinical databasesConduct database build UAT and maintain quality controlled database build documentationAssist 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 neededReview and query clinical trial data according to the Data Management PlanAssist in line listing data review based on the guidance provided by the sponsor and/or Lead DMRun patient and study level status and metric reportingPerform medical coding of medical terms relative to each other in order to ensure medical logic and consistencyAssist with coordinating SAE/AE reconciliationAssist 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 deliverablesMay assist with SAS programming and quality control of SAS programs used in the Data Management departmentMay 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 stakeholdersMay assist in reviewing and providing feedback on protocols, Statistical Analysis Plans (SAP) and Clinical Study Reports (CSRs), if required by the projectMay assist in participating in the development and maintenance of Standard Operating Procedures (SOPs) and corresponding process documentation related to data management and database management activitiesCommunicate with study sponsors, vendors and project teams as needed regarding data, database or other relevant project issuesMay present software demonstrations/trainings, department/company training sessions, present at project meetingsMay require some travelPerform other duties as assignedQualifications:Minimum Required:Bachelor's and/or a combination of related experienceOther Required:3+ years of relevant experienceProficiency in Microsoft Office: Word, Excel, PowerPoint, OutlookAble to handle a variety of clinical research tasksExcellent organizational and communication skillsProfessional use of the English language; both written and oralPreferred:Experience in a clinical, scientific or healthcare discipline

📌 Clinical Data Associate II (Vasanth Nagar)
🏢 Precision for Medicine
📍 Vasanth Nagar