Job Description

Job Description

Job Description: Responsibilities

• Mentor, train, and supervise junior associates as needed in clinical data management processes and procedures.
• Independently lead several complex trials.
• Lead CRF design, review, and validation of clinical database, including management of CRO activities in this area, as assigned if required.
• Be responsible for the creation of data management plans and other data management documentation as needed.
• Monitor the progress and conduct of their respective projects, including all data cleaning and QC activities to ensure all remain on target to project timelines, partnering as appropriate with Clinical Operations, Franchise, and other BSDM (Biostatistics and Data Management) functions.
• Lead, coordinate, facilitate, and manage all data management activities from the initiation of protocol through database lock, partnering as appropriate with Clinical Operations, Franchise, and other BSDM functions for their respective projects.
• Proactively organizes and manages ongoing data review throughout study conduct, including being responsible for the correction of errors and discrepancies in management for the life of a project.
• Proactively identify and address issues that may impact the quality of the data, deliverables, or timelines.
• Be responsible for the identification of data handling processes for non-CRF data, including lab data and image handling.
• Work with BSDM leadership and leadership in Clinical Operations and Franchise to develop project management plans for trial execution, including timelines, milestones, and budgets.
• Lead efforts coordinating with the Medical Affairs organization to facilitate data coding and safety reviews as needed.
• Independently lead new data management initiatives and contribute to the process.
• improvement, data standards, and efficiency-gaining initiatives within data management, working with the project leader on data standards to implement.
• Be responsible for ensuring all clinical data management documentation is stored and archived in a timely and compliant manner.
• Know and follow all laws and policies that apply to the job, and maintain the highest levels of professionalism, ethics, and compliance at all times.
• Diligently participate in compliance program-related activities as denoted by the supervisor or Chief Compliance Officer.
• Perform other related duties as required.

Skills

• Therapeutic area knowledge in at least one of cardiovascular, Neurovascular, or general surgery.
• Proficient in computer technology used in an office environment (Microsoft Word, Excel, etc).
• Excellent verbal and written communication skills.
• Knowledge of GCP and regulatory requirements regarding clinical data management, documentation, and software.
• Experience with Electronic Data Capture (EDC), Medidata RAVE preferred.
• Knowledge of medical terminology and use of coding dictionaries (MedDRA, WHO Drug).
• Proficient-level skills in writing and optimizing SQL queries.
• Familiar with Big Data technologies such as AWS services, Lambda, Glue, orchestration, etc.
• Proficient-level data wrangling with R, Python, and experience with R Studio Connect app development.
• Proficiency in creating visualizations in Tableau.

Education & Experience Requirements

• A Bachelor’s degree (or equivalent) in the biological sciences, Computer Science, or related discipline
• At least 6 years of clinical data management experience in Medical Device or Pharmaceuticals, including experience of successful active participation in cross-functional teams.

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