Work Schedule

Second Shift (Afternoons)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards

Job Description

The Senior Clinical Data Associate (Sr CDA) position at Trialmed (a global site network and the early phase clinical solution for PPD, the clinical research business of Thermo Fisher Scientific Inc.) offers an exceptional opportunity to work with a global team and lead world-class data management projects that drive scientific research forward. As a Sr CDA, you will serve as the supporting data manager for one or more projects, emphasizing flawless execution and strict adherence to project protocols.

Key responsibilities

• Supports the setup of study activities such as database design, testing of data entry screens, and Data Validation Manual (DVM) creation, as required.
• 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.
• Acts as point person and subject matter expert for specialized study-specific processes.
• Provides training and work direction to junior staff as required.
• Contributes to the improvement of data management processes on a global level.
• 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.

Education and Experience

• Bachelor’s degree or equivalent formal academic qualification.
• Minimum of 3+ years of experience in data management or a related field.
• Combination of education, training, and relevant experience may be considered sufficient.

Knowledge, Skills and Abilities

• Applies knowledge and skills in a highly organized fashion while adhering to regulatory guidelines, global SOPs, and client expectations.
• Strong attention to detail, numerical skills, and proficiency with interactive computer programs, including Microsoft Office applications.
• Excellent written and verbal communication skills with a strong command of 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 EDC databases, 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.

Join us in our mission to make the world healthier, cleaner, and safer by successfully implementing your expertise in data management. Apply today and become part of our ambitious team at Trialmed (a global site network and the early phase clinical solution for PPD, the clinical research business of Thermo Fisher Scientific Inc.).