Lab Data Associate II - Clinical Data Management

Home-based in the U.S

Summarized Purpose:

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.Home-based in the U.S

Summarized Purpose:

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.Education and Experience: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 toolsBasic organizational skills with the ability to adapt and adjust to changing priorities and to manage multiple assignments with challenging/conflicting deadlinesEssential interpersonal skills with an internal and external customer focusProven flexibility and adaptability when working in a team and independently using good judgment in making decisionsGood written and verbal communication skillsAbility to maintain a high degree of confidentiality with clinical data and client’s proprietary dataManagement Role: No management responsibilityWorking Environment:PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.Able to work upright and stationary for typical working hours.Ability to use and learn standard office equipment and technology with proficiency.Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.May require travel. 10-20% annual possible. PPD Defining Principles:

- We have a strong will to win - We earn our customer’s trust - We are gamechangers - We do the right thing - We are one PPD

If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, then please submit your application – we’d love to hear from you.

Education and Experience: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 toolsBasic organizational skills with the ability to adapt and adjust to changing priorities and to manage multiple assignments with challenging/conflicting deadlinesEssential interpersonal skills with an internal and external customer focusProven flexibility and adaptability when working in a team and independently using good judgment in making decisionsGood written and verbal communication skillsAbility to maintain a high degree of confidentiality with clinical data and client’s proprietary dataManagement Role: No management responsibilityWorking Environment:PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.Able to work upright and stationary for typical working hours.Ability to use and learn standard office equipment and technology with proficiency.Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.May require travel. 10-20% annual possible. PPD Defining Principles:

- We have a strong will to win - We earn our customer’s trust - We are gamechangers - We do the right thing - We are one PPD

If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, then please submit your application – we’d love to hear from you.