Senior Clinical Data Manager

Role Overview

• The Senior Clinical Data Manager is responsible and manages all aspects of the clinical trial data management process from study start up to post database lock for assigned projects.
• Primary Data Management (DM) contact (Lead DM role) for assigned clinical project(s) / program(s), ensuring that there is back-up, continuity, responsiveness, and that tasks are performed in a timely manner.
• Oversee project data entry process including development of data entry guidelines, training, data entry quality and resourcing.
• Provide input, assesses and manage timelines. Ensure that clinical data management deadlines are met with quality.
• Develop CRF specifications from the clinical study protocol and coordinate the review/feedback from all stakeholders.
• Conduct database build UAT and maintain quality controlled database build documentation. Oversee overall quality of the clinical database.
• Responsible for creating, revising, appropriate versioning and maintaining data management documentation. Oversee completeness of data management documentation for the Trial Master File.
• 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.
• Coordinate SAE/AE reconciliation.

Requirements

• Bachelors and/or a combination of related experience
• 8+ years’ experience
• Able to handle a variety of clinical research tasks
• Excellent organizational and communication skills
• Professional use of the English language; both written and oral
• Experience in utilizing various clinical database management systems
• Broad knowledge of drug, device and/or biologic development and effective data management practices
• Strong representational skills, ability to communicate effectively orally and in writing
• Strong leadership and interpersonal skills
• Systems knowledge with Medidata Rave and Veeva
• Ability to undertake occasional travel

Benefits

• 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.
• 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.
• 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 QuestionForHR@precisionmedicinegrp.com.