Clinical Data Assoc II

Clinical Data Assoc II

6-9 years
Not Specified

Job Description

The objective of a Clinical Data Associate II is to perform advanced aspects of the data cleaning process with a high level of accuracy and in accordance with GCPs and SOPs/WPDs, in order to assess the safety and efficacy of investigational products and/or medical devices. Clinical Data Associate IIs are expected to perform the tasks of a Clinical Data Associate I with increased efficiency, while maintaining a high level of accuracy, and to work more independently. In addition they will be expected to perform data management activities such as Serious Adverse Event and Third Party Vendor reconciliations as well as Data Listing reviews.
  • Identifies, resolves, and updates data discrepancies. Makes changes to the data management database as required. Generates, tracks and resolves data clarifications and queries. May implement CRF design in identified graphic design package
  • Reviews data listings for accuracy and consistency of data. Analyzes and resolves data validation and other data management reports
  • Reads and understands project protocol and Data Validation Manual
  • Produces project-specific status reports for CDM management and for clients on a regular basis.
  • Performs other duties as required

Job Qualification
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 6+ years).
Knowledge, Skills and Abilities:
  • Proven ability in achieving applicable technical competencies per the CDM competency grid.
  • Ability to effectively apply 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.
  • Ability to use interactive computer programs.
  • Good written and verbal communication skills.
  • Good organizational skills
  • Good 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.
  • Ability to attain, maintain and apply a working knowledge of GCPs and applicable SOPs.
  • Strong customer focus and excellent interpersonal skills.
  • Proven flexibility and adaptability.
  • Ability to work in a team environment and independently as needed.
  • Must demonstrate good judgment in making decisions.
  • Must be able to set and meet timelines or be able to negotiate schedule changes in response to project demands.
  • Strong command of English language and grammar.
  • Knowledge of medical/clinical trial terminology.

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