Senior Clin Data Assoc

Role overview

Senior Clin Data Assoc at Thermo Fisher Scientific

Join Us as a Senior Clinical Data Associate – Make an Impact at the Forefront of Innovation.

In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

As a Senior Clinical Data Associate, you will perform all aspects of the data cleaning process, with minimal supervision, 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

• Supports the setup of study activities such as database design, testing of data entry screens, and Data Validation Manual (DVM) creation, as required.
• Reviews data listings for accuracy and consistency of data.
• Acts as point person and subject matter expert for specialized study-specific processes.
• Generates, tracks and resolves data clarifications and queries and makes changes to the clinical database as required.
• Contributes to the improvement of data management processes on a global level.
• Produces project-specific status reports for management and/or clients on a regular basis.
• Provides training and work direction to junior staff as required.
• Bachelor's degree or equivalent and relevant formal academic / vocational qualification .
• Applies knowledge and skills 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.
• 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 .
• Work is performed in an office environment with exposure to electrical office equipment.
• Occasional travel both domestic and international.

Employment details

• Location: Bangalore [Karnātaka] [India]

Additional role details

• Education and Experience Requirements.
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 4 to 7 years).