Data specialist senior associate

The 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. regulatory directives; This position may perform database development and testing, as well as additional data management activities. May perform data entry for paper-CRF studies, as needed May perform quality control of data entry 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 May 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 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 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 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 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 May present software demonstrations/trainings, department/company training sessions, present at project meetings May require some travel 5+ years’ experience ~ Bachelors and/or a combination of related experience Proficiency in Microsoft Office: Word, Excel, Power Point, Outlook. Able to handle a variety of clinical research tasks. Professional use of the English language; Basic knowledge of drug, device and/or biologic development and effective data management practices. Experience in a clinical, scientific or healthcare discipline. Dictionary medical coding (Med DRA and WHODrug)Oncology and/or Orphan Drug therapeutic experience Demonstrates strong knowledge of ICH-GCP, relevant Precision Oncology SOPs, and regulatory guidance, as well as the ability to implement and drive outcomes Motivates project team members to meet timelines and project goals Resolves project related problems and prioritizes workload to meet deadlines with minimal support Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice . 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. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at