Assoc Project Design Manager - Central Lab

Company Overview:

PPD is a leading global contract research organization. At PPD we are passionate, deliberate, and driven by our purpose - to improve health!

PPD Laboratories offers the most comprehensive set of laboratory services available in the industry. Our scientists work together to accelerate pharmaceutical development for small molecules, biologics, and vaccines -allowing our clients to make faster decisions about their compounds.

At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. It's not just talk, our award-winning training programs speak for themselves.

To learn how PPD can advance your career, apply now!

Role Summary:

The Associate Project Design Manager independently reviews clinical trial protocols and interprets Central Lab responsibilities based on protocol definitions and budgeted services. This role supports the Project Manager in the review of draft laboratory specifications document for consistency with protocol and budgeted requirements; provides feedback to the Project Manager regarding budget and/or protocol discrepancies, system design requirements, and/or concerns. In this position you will advise Project Managers on procedural and budgetary items and the necessity for change due to database configuration requirements. The ability to work on a team, as well as independently, while maintaining clear communication and attention to detail is key to this role!

Additional Job Tasks: Ensures consistency of database design across sponsors and/or programs. Configures Collection Flow Chart (CFC) based on protocol testing requirements, assay volumes, testing location, sample stability, and frequency of testing. Determines appropriate testing to sample allocation based on testing schedule, processing instructions, sample disposition, and third-party lab requirements. Configures Kit Specifications based on protocol testing requirements, assay volumes, testing schedule, testing location, sample stability, testing frequency, study population, assay platform, total allowable blood volume, sponsor/program requirements, as well as determining ancillary supply requirements based on matrices, time points, study population, and collection device requirements. Configures sample labels based on client needs and collection requirements. Attends internal and external meetings and teleconferences; provides Project Manager support during laboratory specifications development discussions with client. Works cross-departmentally to ensure study database design meets client needs, as well as internal requirements. Seeks input and guidance from Project Design leads and managers when necessary. Under general supervision and guidance from Project Design leads and managers, builds study database and creates study deliverables within the time lines established by the team and indicated by the contract. Supports Project Management group with the development and implementation of study database design modifications. Performs database modifications based on client requirements; updates CFC, Kit Specifications, and sample labels, as appropriate, based on database modifications. Monitors assignments and adjusts priorities and work schedule to meet deadlines and provide high quality deliverables. Completes additional tasks as needed to support project, client, and departmental objectives. Understands and follows department's working practice documents and SOPs, and contributes to their development as needed, as well as understands and follows appropriate corporate SOPs.

Company Overview:

PPD is a leading global contract research organization. At PPD we are passionate, deliberate, and driven by our purpose - to improve health!

PPD Laboratories offers the most comprehensive set of laboratory services available in the industry. Our scientists work together to accelerate pharmaceutical development for small molecules, biologics, and vaccines -allowing our clients to make faster decisions about their compounds.

At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. It's not just talk, our award-winning training programs speak for themselves.

To learn how PPD can advance your career, apply now!

Role Summary:

The Associate Project Design Manager independently reviews clinical trial protocols and interprets Central Lab responsibilities based on protocol definitions and budgeted services. This role supports the Project Manager in the review of draft laboratory specifications document for consistency with protocol and budgeted requirements; provides feedback to the Project Manager regarding budget and/or protocol discrepancies, system design requirements, and/or concerns. In this position you will advise Project Managers on procedural and budgetary items and the necessity for change due to database configuration requirements. The ability to work on a team, as well as independently, while maintaining clear communication and attention to detail is key to this role!

Additional Job Tasks: Ensures consistency of database design across sponsors and/or programs. Configures Collection Flow Chart (CFC) based on protocol testing requirements, assay volumes, testing location, sample stability, and frequency of testing. Determines appropriate testing to sample allocation based on testing schedule, processing instructions, sample disposition, and third-party lab requirements. Configures Kit Specifications based on protocol testing requirements, assay volumes, testing schedule, testing location, sample stability, testing frequency, study population, assay platform, total allowable blood volume, sponsor/program requirements, as well as determining ancillary supply requirements based on matrices, time points, study population, and collection device requirements. Configures sample labels based on client needs and collection requirements. Attends internal and external meetings and teleconferences; provides Project Manager support during laboratory specifications development discussions with client. Works cross-departmentally to ensure study database design meets client needs, as well as internal requirements. Seeks input and guidance from Project Design leads and managers when necessary. Under general supervision and guidance from Project Design leads and managers, builds study database and creates study deliverables within the time lines established by the team and indicated by the contract. Supports Project Management group with the development and implementation of study database design modifications. Performs database modifications based on client requirements; updates CFC, Kit Specifications, and sample labels, as appropriate, based on database modifications. Monitors assignments and adjusts priorities and work schedule to meet deadlines and provide high quality deliverables. Completes additional tasks as needed to support project, client, and departmental objectives. Understands and follows department's working practice documents and SOPs, and contributes to their development as needed, as well as understands and follows appropriate corporate SOPs.

Education and Experience: 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 0 to 2 years).

Knowledge, Skills and Abilities: Fundamental oral and written communication skills Good organizational skills with the ability to adapt and adjust to changing priorities and to manage multiple assignments with challenging/conflicting deadline Capable of maintaining a high degree of confidentiality with clinical data and client’s proprietary dataGood attention to detail and problem solving skills Positive attitude, enthusiasm toward work, and a good team player Good computer skills Basic understanding of relational database systems (RDBMS) and structures Basic understanding of general reporting and dashboarding tools is preferred Basic understanding of XML and Stylesheet transformations is preferred

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. (Recruiter will provide more details.)

Pharmaceutical Product Development, LLC is firmly committed to Equal Employment Opportunity (EEO) and prohibits employment discrimination for employees and applicants based on age, race, color, pregnancy, gender, gender identity, sexual orientation, national origin, religion, marital status, citizenship, disability or protected veteran or other status protected by federal, state, and/or local law.

Education and Experience: 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 0 to 2 years).

Knowledge, Skills and Abilities: Fundamental oral and written communication skills Good organizational skills with the ability to adapt and adjust to changing priorities and to manage multiple assignments with challenging/conflicting deadline Capable of maintaining a high degree of confidentiality with clinical data and client’s proprietary dataGood attention to detail and problem solving skills Positive attitude, enthusiasm toward work, and a good team player Good computer skills Basic understanding of relational database systems (RDBMS) and structures Basic understanding of general reporting and dashboarding tools is preferred Basic understanding of XML and Stylesheet transformations is preferred

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. (Recruiter will provide more details.)

Pharmaceutical Product Development, LLC is firmly committed to Equal Employment Opportunity (EEO) and prohibits employment discrimination for employees and applicants based on age, race, color, pregnancy, gender, gender identity, sexual orientation, national origin, religion, marital status, citizenship, disability or protected veteran or other status protected by federal, state, and/or local law. US-NC-Wilmington-Wilmington NC HQ, BE-BE-Zaventem-Zaventem BE Cluster Pk, GB-GB-Bellshill-Bellshill GB Fleming House 1, US-NC-Morrisville-Morrisville NC 3900 Paramount, GB-GB-Cambridge-Cambridge GB Granta Park1US-NC-Wilmington-Wilmington NC HQ, BE-BE-Zaventem-Zaventem BE Cluster Pk, GB-GB-Bellshill-Bellshill GB Fleming House 1, US-NC-Morrisville-Morrisville NC 3900 Paramount, GB-GB-Cambridge-Cambridge GB Granta Park1