Lab Data Specialist - Clinical Data Management

Home-based in the U.S

Summarized Purpose:Acts as a senior data management specialist for one or more local laboratory data projects. Leads all data management activities associated with local labs for individual studies and serves as a cross-functional liaison. May support more complex projects.

Essential Functions:Collaborates on the design and user acceptance testing of local lab eCRFs and ensures proper set up of specific lab tool.Ensures data entry and review are performed and consistent with requirements defined by procedure and Data Validation Manual.Reviews lab related documentation and listing review tools for compliance with study protocol and lab standards.Liaises with colleagues in other functional groups, and provides support to senior team members by providing training to clinical staff on local lab procedures, attending project and client team meetings when required, and working with medical monitors to ensure robust review of local lab and related data.Provides training and work direction to junior team members.Ensures study specific lab normal range mailbox is effectively managed by junior level staff.Reviews all lab documentation within Data Validation Manual, Electronic Edit Checks, and eCRF Completion GuidelinesHome-based in the U.S

Summarized Purpose:Acts as a senior data management specialist for one or more local laboratory data projects. Leads all data management activities associated with local labs for individual studies and serves as a cross-functional liaison. May support more complex projects.

Essential Functions:Collaborates on the design and user acceptance testing of local lab eCRFs and ensures proper set up of specific lab tool.Ensures data entry and review are performed and consistent with requirements defined by procedure and Data Validation Manual.Reviews lab related documentation and listing review tools for compliance with study protocol and lab standards.Liaises with colleagues in other functional groups, and provides support to senior team members by providing training to clinical staff on local lab procedures, attending project and client team meetings when required, and working with medical monitors to ensure robust review of local lab and related data.Provides training and work direction to junior team members.Ensures study specific lab normal range mailbox is effectively managed by junior level staff.Reviews all lab documentation within Data Validation Manual, Electronic Edit Checks, and eCRF Completion GuidelinesEducation and Experience:Bachelor's degree or equivalent and relevant formal academic / vocational qualificationPrevious experience that provides the knowledge, skills, and abilities to perform the job (comparable to 3 years).In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.Knowledge, Skills and Abilities:Solid 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 toolsGood organizational skills with the ability to adapt and adjust to changing priorities and to manage multiple assignments with challenging/conflicting deadlinesFavorable interpersonal skills with an internal and external customer focusCapable of mentoring junior level staffProven flexibility and adaptability when working in a team and independently using good judgment in making decisionsGood computer skills and knowledge of databases and how to effectively extract and interpret dataStrong written and verbal communication skillsAbility to maintain a high degree of confidentiality with clinical data and client’s proprietary dataDemonstrated ability to analyze processes and contribute to process improvement initiativesFamiliarity with the broader clinical trial processManagement 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:Bachelor's degree or equivalent and relevant formal academic / vocational qualificationPrevious experience that provides the knowledge, skills, and abilities to perform the job (comparable to 3 years).In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.Knowledge, Skills and Abilities:Solid 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 toolsGood organizational skills with the ability to adapt and adjust to changing priorities and to manage multiple assignments with challenging/conflicting deadlinesFavorable interpersonal skills with an internal and external customer focusCapable of mentoring junior level staffProven flexibility and adaptability when working in a team and independently using good judgment in making decisionsGood computer skills and knowledge of databases and how to effectively extract and interpret dataStrong written and verbal communication skillsAbility to maintain a high degree of confidentiality with clinical data and client’s proprietary dataDemonstrated ability to analyze processes and contribute to process improvement initiativesFamiliarity with the broader clinical trial processManagement 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.