Lab Data Assoc Ii

3 weeks ago

Bengaluru, India PPD Full time

Performs all aspects of the data management local lab normal range entry and data cleaning process in support of senior team members, in accordance with GCP and SOPs/WPDs in order to assess the safety and efficacy of investigational products.

**Essential Functions**:
Performs entry and QC visual verification of laboratory range data into CDMS.Reviews data listings for accuracy and consistency of data.Generates, tracks and resolves local lab data clarifications and queries and makes changes to the clinical database lab tool as required.Reads and understands project protocols and Data Validation Manuals.Liaises with clinical team members to resolve issues with missing or invalid lab normal ranges.Escalates issues to senior team members and/or management for transparency.Produces project-specific status reports for leads and clinical staff on a regular basis.

High / Secondary school diploma or equivalent and relevant formal academic / vocational qualificationTechnical positions may require a certificatePrevious experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 6 years).

**Knowledge, Skills and Abilities**:
High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification.

Technical positions may require a certificatePrevious experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 6 years).

**Knowledge, Skills and Abilities**:
Basic understanding of challenges of local lab data used in clinical trials to include -collection of local lab ranges, relationship between local lab results and units, relationship between local lab results, ranges and potential adverse events, relationship between local lab data and CTCAE or other grading tools

Basic organizational skills with the ability to adapt and adjust to changing priorities and to manage multiple assignments with challenging/conflicting deadlines

Essential interpersonal skills with an internal and external customer focus

Proven flexibility and adaptability when working in a team and independently using good judgment in making decisionsGood written and verbal communication skills

Ability to maintain a high degree of confidentiality with clinical data and client’s proprietary data

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