Project Mgr - Labs (Biopharmaceuticals)

PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services.  At PPD, we are passionate, deliberate, and driven by our purpose- to improve health! 

Envision a workplace where you have a direct impact on improving health, work alongside expert scientists, use newest technologies and collaborate with industry thought leaders and therapeutic experts. Welcome to PPD® Laboratories, where science is our passion, quality is our commitment and people are the cornerstone of our success.

As a Project Manager you will manage all aspects of study programs, while collaborating with diverse teams.

At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and wellbeing of our employees.

Summarized Purpose:

Responsible for the overall coordination and management of chemistry, manufacturing and controls (CMC) testing for biopharmaceuticals following current good manufacturing practices (cGMP) across all phases of development. Directs theoperational aspects of the projects, securing the successful completion of CMC testing. Works with major functional area leads to identify and evaluate fundamental issues on the project, interpret data on complex issues, makes sound business decisions and ensure solutions are implemented. Works to ensure all project deliverables meet the customer’s time/quality/cost expectations. Accountable for ensuring all project deliverables meet the customer/contract expectations, providing accurate hour forecasts, reviewing pass-through costs and ensuring timely invoicing with the support of Project Management Directors and/or Associate Directors while working in collaboration with other functional area leads.

Essential Functions : Manages allocated studies according to timelines and quality standards. Coordinates activities of all functional departments and vendors involved in the project. Works with team and management to develop plans/guidelines for project implementation using PPD tools. Monitors and analyzes project status to ensure successful completion of project parameters, milestones, timetables (i.e., regulatory document, research agreement, site payments, etc.). Works with team to identify potential risks, develop contingency plans. Acts as principal liaison between clientand PPD by facilitating the flow of information. Provides clientwith timely project updates, project related fiscal information, ensures correct protocol interpretations, and obtains direction and feedback on implementing scope of work. May discuss and obtain feedback from clientsregarding PPD’s performance to date. Plans and communicates to team members study specific tasks and priorities for projects. Delegates, as appropriate, assigned responsibilities to project team members. Liaises with managers in all functional areas within PPD to optimize performance and utilization of the project team members. Appropriately escalates any issues or potential issues to the Project Management Director or Associate Director for all project related issues. Works closely with finance and legal to manage all financial and contractual aspects of the study including establishing and recognizing financial milestones for invoice and subcontractor purposes, subcontracting with third-party service providers, approving subcontractor invoices, establishing proper accrual for investigator grants, assisting with negotiation of the investigator grants as needed and similar pass-throughs. Works with the project team to establish appropriate controls to ensure that project resources and expenses are aligned with budgets. Works closely with Project Management Director or Associate Director to provide details for the development and negotiation of contract modifications, as needed. Ensures that appropriate assessment and coordination of project/protocol specific and therapeutic area training needs and activities are occurring for the team members as needed. Provides input intoperformance management, training and other activities related to leading project staff members across functional areas. Works to prepare and present at client meetings as the assigned Project Manager.

PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services.  At PPD, we are passionate, deliberate, and driven by our purpose- to improve health! 

Envision a workplace where you have a direct impact on improving health, work alongside expert scientists, use newest technologies and collaborate with industry thought leaders and therapeutic experts. Welcome to PPD® Laboratories, where science is our passion, quality is our commitment and people are the cornerstone of our success.

As a Project Manager you will manage all aspects of study programs, while collaborating with diverse teams.

At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and wellbeing of our employees.

Summarized Purpose:

Responsible for the overall coordination and management of chemistry, manufacturing and controls (CMC) testing for biopharmaceuticals following current good manufacturing practices (cGMP) across all phases of development. Directs theoperational aspects of the projects, securing the successful completion of CMC testing. Works with major functional area leads to identify and evaluate fundamental issues on the project, interpret data on complex issues, makes sound business decisions and ensure solutions are implemented. Works to ensure all project deliverables meet the customer’s time/quality/cost expectations. Accountable for ensuring all project deliverables meet the customer/contract expectations, providing accurate hour forecasts, reviewing pass-through costs and ensuring timely invoicing with the support of Project Management Directors and/or Associate Directors while working in collaboration with other functional area leads.

Essential Functions : Manages allocated studies according to timelines and quality standards. Coordinates activities of all functional departments and vendors involved in the project. Works with team and management to develop plans/guidelines for project implementation using PPD tools. Monitors and analyzes project status to ensure successful completion of project parameters, milestones, timetables (i.e., regulatory document, research agreement, site payments, etc.). Works with team to identify potential risks, develop contingency plans. Acts as principal liaison between clientand PPD by facilitating the flow of information. Provides clientwith timely project updates, project related fiscal information, ensures correct protocol interpretations, and obtains direction and feedback on implementing scope of work. May discuss and obtain feedback from clientsregarding PPD’s performance to date. Plans and communicates to team members study specific tasks and priorities for projects. Delegates, as appropriate, assigned responsibilities to project team members. Liaises with managers in all functional areas within PPD to optimize performance and utilization of the project team members. Appropriately escalates any issues or potential issues to the Project Management Director or Associate Director for all project related issues. Works closely with finance and legal to manage all financial and contractual aspects of the study including establishing and recognizing financial milestones for invoice and subcontractor purposes, subcontracting with third-party service providers, approving subcontractor invoices, establishing proper accrual for investigator grants, assisting with negotiation of the investigator grants as needed and similar pass-throughs. Works with the project team to establish appropriate controls to ensure that project resources and expenses are aligned with budgets. Works closely with Project Management Director or Associate Director to provide details for the development and negotiation of contract modifications, as needed. Ensures that appropriate assessment and coordination of project/protocol specific and therapeutic area training needs and activities are occurring for the team members as needed. Provides input intoperformance management, training and other activities related to leading project staff members across functional areas. Works to prepare and present at client meetings as the assigned Project Manager. 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 2 years’) or equivalent combination of education, training, & experience.

Knowledge, Skills and Abilities:

Strong verbal, written and presentation skills Superior time management, planning, and organizational skills Competent with specific computers and enterprise applications, including office productivity Ability to program the IT system according to protocol requirements Proven analytical skills Demonstrated compliance with procedures and policies Ability to perform multiple tasks effectively in a stressful environment Extensive knowledge and experience in Project Management in Global Central Lab environment Strong client relationship management skills Ability to work effectively with multi-level teams Working 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.  (Recruiter will provide more details.) 

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 qualification

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2 years’) or equivalent combination of education, training, & experience.

Knowledge, Skills and Abilities:

Strong verbal, written and presentation skills Superior time management, planning, and organizational skills Competent with specific computers and enterprise applications, including office productivity Ability to program the IT system according to protocol requirements Proven analytical skills Demonstrated compliance with procedures and policies Ability to perform multiple tasks effectively in a stressful environment Extensive knowledge and experience in Project Management in Global Central Lab environment Strong client relationship management skills Ability to work effectively with multi-level teams Working 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.  (Recruiter will provide more details.) 

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