Sr. Clinical Data Associate

About This Role

Making an impact at the forefront of innovation, the Senior Clinical Data Associate performs all aspects of the data cleaning process with minimal supervision. This role ensures operational excellence in accordance with Good Clinical Practices (GCP) and Standard Operating Procedures/Work Process Documents (SOPs/WPDs) to assess the safety and efficacy of investigational products and/or medical devices.

Responsibilities

• Support the setup of study activities such as database design, testing of data entry screens, and Data Validation Manual (DVM) creation, as required
• Review data listings for accuracy and consistency of data
• Act as point person and subject matter expert for specialized study-specific processes
• Generate, track and resolve data clarifications and queries and make changes to the clinical database as required
• Contribute to the improvement of data management processes on a global level
• Produce project-specific status reports for management and/or clients on a regular basis
• Provide training and work direction to junior staff as required

Requirements

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 2 years)
• Knowledge and skills applied in a highly organized fashion while adhering to regulatory guidelines, global SOPs and client expectations
• Strong attention to detail and skill with numbers
• Good written and verbal communication skills
• Good analytical/problem-solving skills
• Ability to maintain a high degree of confidentiality with clinical data and client's proprietary data
• Strong customer focus and excellent interpersonal skills
• Proven flexibility and adaptability
• Must be able to set and meet timelines or be able to negotiate schedule changes in response to project demands
• Knowledge of medical/clinical terminology
• Understands project protocol and DVM
• Proven ability in achieving applicable technical competencies per the DM competency grid

Benefits

• Part of a global team that values passion, innovation, and a commitment to scientific excellence
• Work in an environment where collaboration and development are part of the everyday experience

Important Details

• Schedule: Standard (Monday-Friday)
• Environmental Conditions: Office
• Occasional drives to site locations
• Occasional travel both domestic and international

About the Company