Sr Project Manager - Central Lab

Company Overview:

We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients.  

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.

Summeraized Purpose:

As a Sr. Project Manager for PPD's central lab you will oversee coordination and management of clinical trials from start up through close out activities. Directs the technical and operational aspects of the projects, securing the successful completion of clinical trials. Workwith 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. Ensureall project deliverables meet the customer/contract expectations, providing accurate hour forecasts, reviewing pass-through costs and ensuring timely invoicing 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. Ensures teams are entering and updating internal tracking tools. Works with team to identify potential risks, develop contingency plans. Acts as principal liaison between Sponsor and PPD by facilitating the flow of information between PPD and client. Provides Sponsor withtimely project updates, project related fiscal information, ensures correct protocol interpretations, and obtains direction and feedback on implementing scope of work. Discusses and obtains feedback from Sponsors regarding 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 management for all project related issues. Works closely with other departments 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. 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 into hiring, performance management, training and other activities related to leading project staff members across functional areas.

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

#PPDlabs

#LI-DK1

#GD

Company Overview:

We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients.  

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.

Summeraized Purpose:

As a Sr. Project Manager for PPD's central lab you will oversee coordination and management of clinical trials from start up through close out activities. Directs the technical and operational aspects of the projects, securing the successful completion of clinical trials. Workwith 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. Ensureall project deliverables meet the customer/contract expectations, providing accurate hour forecasts, reviewing pass-through costs and ensuring timely invoicing 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. Ensures teams are entering and updating internal tracking tools. Works with team to identify potential risks, develop contingency plans. Acts as principal liaison between Sponsor and PPD by facilitating the flow of information between PPD and client. Provides Sponsor withtimely project updates, project related fiscal information, ensures correct protocol interpretations, and obtains direction and feedback on implementing scope of work. Discusses and obtains feedback from Sponsors regarding 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 management for all project related issues. Works closely with other departments 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. 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 into hiring, performance management, training and other activities related to leading project staff members across functional areas.

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

#PPDlabs

#LI-DK1

#GD

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 8 years’) or equivalent combination of education, training, &experience. Central lab or CRO experience preferred

Years of experience refers to typical years of related experience needed to gain the required knowledge, skills,and abilities necessary to perform the essential functionsof the job.Years of experience are not tobe used as theonly determining factor in establishing the job classor making employment selection decisions.

Knowledge, Skills and Abilities: Knowledge of the key principles of cross functional project management (Time, Quality, Cost) Solid financial acumen Ability to effectively plan and deliver a dynamic and persuasive presentation Displays effective communication skills (listening, oral, written) and can communicate in English language (oral, written) Sound interpersonal skills, is flexible and adapts to changing situations Ability to persuade, convince, and influence or impress others Organized, proficient at multitasking with good attention to detail Able to delegate, effectively prioritizes own and workload of project team members Ability to effectively use automated systems and computerized applications such as Outlook, Excel, Word, etc. In-depth understanding and appreciation of clinical research/development, including medical and therapeutic areas, phases and medical terminology In-depth knowledge/understanding of clinical development guidelines and directives

Working Conditions and Environment: Work is performed in a laboratory and/or a clinical environment with exposure to electrical office equipment. Occasional drives to site locations, occasional domestic travel. Exposure to biological fluids with potential exposure to infectious organisms. Rare exposure to skin and lung irritants, radiation, toxic materials and hazardous waste. Personal protective equipment required such as protective eyewear, garments and gloves. Exposure to fluctuating and/or extreme temperatures on rare occasions.

Physical Requirements: Ability to work in an upright and /or stationary position for 6-8 hours per day. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists to operate lab equipment. Occasional mobility needed. Occasional crouching, stooping, with frequent bending and twisting of upper body and neck. Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs. Ability to access and use a variety of computer software developed both in-house and off-the-shelf. Ability to communicate information and ideas so otherswill understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Frequently interacts with others to obtain or relate information to diverse groups. Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Requires multiple periods of intense concentration. Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task. Regular and consistent attendance.

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 8 years’) or equivalent combination of education, training, &experience. Central lab or CRO experience preferred

Years of experience refers to typical years of related experience needed to gain the required knowledge, skills,and abilities necessary to perform the essential functionsof the job.Years of experience are not tobe used as theonly determining factor in establishing the job classor making employment selection decisions.

Knowledge, Skills and Abilities: Knowledge of the key principles of cross functional project management (Time, Quality, Cost) Solid financial acumen Ability to effectively plan and deliver a dynamic and persuasive presentation Displays effective communication skills (listening, oral, written) and can communicate in English language (oral, written) Sound interpersonal skills, is flexible and adapts to changing situations Ability to persuade, convince, and influence or impress others Organized, proficient at multitasking with good attention to detail Able to delegate, effectively prioritizes own and workload of project team members Ability to effectively use automated systems and computerized applications such as Outlook, Excel, Word, etc. In-depth understanding and appreciation of clinical research/development, including medical and therapeutic areas, phases and medical terminology In-depth knowledge/understanding of clinical development guidelines and directives

Working Conditions and Environment: Work is performed in a laboratory and/or a clinical environment with exposure to electrical office equipment. Occasional drives to site locations, occasional domestic travel. Exposure to biological fluids with potential exposure to infectious organisms. Rare exposure to skin and lung irritants, radiation, toxic materials and hazardous waste. Personal protective equipment required such as protective eyewear, garments and gloves. Exposure to fluctuating and/or extreme temperatures on rare occasions.

Physical Requirements: Ability to work in an upright and /or stationary position for 6-8 hours per day. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists to operate lab equipment. Occasional mobility needed. Occasional crouching, stooping, with frequent bending and twisting of upper body and neck. Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs. Ability to access and use a variety of computer software developed both in-house and off-the-shelf. Ability to communicate information and ideas so otherswill understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Frequently interacts with others to obtain or relate information to diverse groups. Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Requires multiple periods of intense concentration. Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task. Regular and consistent attendance.