CDA II

Job Description :

Work Schedule

Environmental Conditions

Join Us as a Clinical Data Assoc II - Make an Impact at the Forefront of Innovation
We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.

As part of our expert team, you'll have the opportunity to ensure operational excellence that makes a real difference in organizational performance. As a Clinical Data Assoc II, you will perform advanced aspects of the data cleaning process with a high level of accuracy and in accordance with Good Clinical Practices (GCPs) and Standard Operating Procedures/Work Process Documents (SOPs/WPDs), to assess the safety and efficacy of investigational products and/or medical devices.

What You'll Do:

. Identify, resolve, and update data discrepancies. Make changes to the data management database as required.
. Generate, track and resolve data clarifications and queries. May implement CRF design in identified graphic design package.
. Review data listings for accuracy and consistency of data. Analyze and resolve data validation and other data management reports.
. Produce project-specific status reports for CDM management and for clients on a regular basis.
. Perform data management activities such as Serious Adverse Event and Third Party Vendor reconciliations as well as Data Listing reviews.

Education and Experience Requirements:
. Any Life Science Graduate
. Technical positions may require a certificate
. 4-6 Years of experience in Clinical Data Manager Role

Having Experience in Veeva EDC is preferred.

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 and skill with numbers and ability to use interactive computer programs
. Good written and verbal communication skills and a strong command of English language and grammar
. Good organizational and analytical/problem-solving skills
. Ability to work productively with moderate supervision
. 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, adaptability and ability to work in a team environment or independently as needed
. Must demonstrate good judgment in making decisions
. Knowledge of medical/clinical trial terminology
. Understands project protocol and Data Validation Manual

Working Conditions and Environment:
. Work is performed in an office or clinical environment with exposure to electrical office equipment.
. Occasional drives to site locations. Potential Occasional travel required.

Why Join Us

When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You'll work in an environment where collaboration and development are part of the everyday experience-and where your contributions truly make a difference.

Apply today to help us deliver tomorrow's breakthroughs.