Remote - Senior Clinical Data Manager

A highly reputable oncology biotechnology corporation is currently looking to hire an experienced and qualified Remote Senior Clinical Data Manager to work remotely in the United States.

Essential Job Functions :

• As a Senior Clinical Data Manager, you will play a key role in providing oversight to ensure complete, accurate and high-quality data collection for outsourced and inhouse trials.
• Provide support within the organization to develop and implement clinical data management standards and processes.
• Responsible for leading clinical data activities across multiple studies from study start-up to study closure for early stage clinical programs
• Working with a dynamic and multi-disciplinary team and be able to work independently and collaboratively with key functions both internally and externally
• Provide leadership for clinical data management (CDM) function; ensure CDM deliverables are completed on time, within budget and in accordance with quality standards and study requirements
• Responsible for leading Clinical Data Management activities for multiple trials including the oversight of CRO and/or CDM vendors to ensure that project goals are achieved and adherence to scope of work and service agreements
• Establish and maintain strong relationships with internal cross-functional teams, vendors and clinical research site personnel for successful execution of clinical trial
• Lead and oversee Electronic Data Capture (EDC) build, migration and deployment including creation and execution of user acceptance testing plans and test scripts, and implementation of data integrations with external vendor data sources (e.g., IRT, laboratory, imaging)
• Oversee set-up of other clinical management systems (e.g., IxRS) and data transfer agreements with external vendors
• Write or contribute to preparation of CDM documents
• Lead the development of EDC custom and Business Objective reports, SAS clinical programming report specifications and data visualization output
• In collaboration with Study Execution Team, participate in clinical document review such as clinical protocols, statistical analysis plans, protocol deviation plans, mock tables, figures and listings
• Report Data Management metrics and trends; identify barriers to timely and successful trial execution and propose solutions
• Lead clinical data review of data listings and summary tables.
• Implement data review strategy via use of data integration or visualization platform
• Serve as a subject matter expert on CDM systems and processes
• Lead CDM standardization and development of Standard Operation Procedures, work instructions and other infrastructure as needed; may include standard CDASH case report form library and associated edit checks

Requirements:

• Bachelors Degree in life sciences or related discipline
• 6+ years of experience in clinical data management or relevant work experience
• CRO or CDM vendor management experience in oncology
• Early phase adaptive trial management experience preferred
• Experience with CDASH terminology and/or MedDRA and WhoDrug medical coding
• Experience with SAS programming techniques is a plus
• Experience with RaveX and/or Veeva EDC is a plus
• Experience with Spotfire is a plus

Knowledge, Skills and Abilities:

• Strong working knowledge of CDISC standards, FDA and ICH/GCP regulations and guidelines
• Proficient on EDC configuration and design, testing and validation, data collection and data review process, and data standardization
• Self-motivated and takes pride in your work
• Results-oriented team player; enjoy working collaboratively with colleagues and building positive relationships
• Attention to detail, ability to proactively identify issues and address with solutions-oriented approach