Clinical Data Associate II
- Bangalore, Karnataka
- Permanent
- Full-time
- Identifies, resolves, and updates data discrepancies, making necessary changes to the data management database.
- Generates, tracks, and resolves data clarifications and queries; may implement CRF design in identified graphic design package.
- Reviews data listings for accuracy and consistency, analyzing and resolving data validation and other data management reports.
- Produces project-specific status reports for CDM management and clients regularly.
- Performs data management activities such as Serious Adverse Event and Third-Party Vendor reconciliations, as well as Data Listing reviews.
- Performs advanced aspects of the data cleaning process with high accuracy, in accordance with GCPs and SOPs/WPDs, to assess the safety and efficacy of investigational products and/or medical devices.
- Works on difficult or complex assignments require considerable judgment and initiative to resolve issues, understanding the implications of work and making recommendations for solutions and/or new procedures.
- As a skilled or highly skilled specialist, completes tasks resourcefully and creatively, contributing to the development of concepts and techniques.
- May act independently in determining methods and procedures on new assignments, potentially serving as a facilitator and/or team leader (formal or informal).
- Frequently contacts individuals representing outside organizations or of significant importance within the company, involving planning and preparation of communications requiring skill, tact, persuasion, and/or negotiation to accomplish objectives.
- Bachelor’s degree or equivalent formal academic qualification.
- Minimum of 2+ years of experience in data management or a related field.
- Combination of education, training, and relevant experience may be considered sufficient.
- Applies knowledge and skills in a highly organized fashion while adhering to regulatory guidelines, global SOPs, and client expectations.
- Solid attention to detail, numerical skills, and proficiency with interactive computer programs, including Microsoft Office applications.
- Excellent written and verbal communication skills with a good command of the English language and grammar.
- Good organizational, analytical, and problem-solving skills, capable of working productively with moderate supervision.
- Fast and agile learner, capable of quickly adapting to new information and environments, including the use of Generative AI tools.
- Effective interaction with global teams, demonstrating strong interpersonal skills, cultural awareness, and a strong customer focus.
- Proactive and self-motivated, with excellent time management skills and the ability to organize tasks efficiently and adhere to schedules.
- Experience with DM EDCdatabases, particularly Medidata Rave and Veeva Vault, and knowledge of good documentation practices such as eTMF.
- Ability to maintain a high degree of confidentiality with clinical and proprietary data. • Flexibility and adaptability, capable of working in a team environment or independently, demonstrating good judgment in decision-making.
- Knowledge of medical/clinical trial terminology and understanding of project protocols and Data Validation Manual. Working Conditions
- The standard working hours are from 1:00 PM to 10:00 PM IST.
- Employees have the flexibility to choose between office, remote, or hybrid work options.