Clinical Project Manager (Contract Research Organization) - Contract Opportunity

Submission for the position: Clinical Project Manager (Contract Research Organization) - Contract Opportunity - (Job Number: 168167)

Clinical Team - Project Manager - PPD Outsourcing Solutions Group

*Home-Based/Remote Based Contract/Temp Opportunity

*Full Time (FTE 1.0)

*6 month duration

The PPD flexible staffing program, with our internal PPD Outsourcing Solutions Group (OSG) offers flexible work options where you can be a part of the PPD culture as a contract, temporary worker, consultant worker or freelancer.

*Register today to hear more about open or future these opportunities at PPD!*

The Project Manager (Contract/Temporary Opportunity) will be r esponsible for the overall coordination and management of clinical trials from start up through to final deliverables. Direct the technical and operational aspects of the projects, securing the successful completion of clinical trials.

Work 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. Work 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.

Clinical Team - Project Manager - PPD Outsourcing Solutions Group

*Home-Based/Remote Based Contract/Temp Opportunity

*Full Time (FTE 1.0)

*6 month duration

The PPD flexible staffing program, with our internal PPD Outsourcing Solutions Group (OSG) offers flexible work options where you can be a part of the PPD culture as a contract, temporary worker, consultant worker or freelancer.

*Register today to hear more about open or future these opportunities at PPD!*

The Project Manager (Contract/Temporary Opportunity) will be r esponsible for the overall coordination and management of clinical trials from start up through to final deliverables. Direct the technical and operational aspects of the projects, securing the successful completion of clinical trials.

Work 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. Work 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 clinical studies according to timelines and quality standards. Coordinates activities of all functional departments and vendors involved in the project; in some cases the multi-functional project management lead will have to take direct responsibility for the clinical subspecialty functional area. 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, interim monitoring, CRF retrieval, CRF data entry, etc.). Ensures teams are entering and updating internal tracking tools e.g. Project Pulse, CASCADE, etc. 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 with 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 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 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 into hiring, performance 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. Attends bid defenses as necessary.

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 8 years’) or equivalent combination of education, training, & experience. Years of experience refers to typical years of related experience needed to gain the required knowledge, skills, and abilities necessary to perform the essential functions of the job. Years of experience are not to be used as the only determining factor in establishing the job class or making employment selection decisions.

Knowledge, Skills and Abilities:

Knowledge of the key principles of cross functional project management (Time, Quality, Cost).

Solid financial acumen.

Apply a range of negotiation techniques to achieve desired outcomes with evidence of commercial and organizational acumen.

Display effective communication skills (listening, oral, written) and can communicate in English language (oral and written).

Interpersonal skills and ability to adapt quickly to change.

Organized, proficient at multi-tasking with good attention to detail.

Able to lead, motivate and coordinate teams. Coach/mentor team members as appropriate.

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.

Possesses cross cultural awareness and is able to adapt appropriately.

Understanding and appreciation of clinical research/development, including

medical and therapeutic areas, phases and medical terminology.

Experience with leading, liaising and coordinating cross-functional project teams.

Knowledge/understanding of clinical development guidelines and directives.

Working Conditions and Environment:

Work is performed in an office/ laboratory and/or a clinical environment.

Exposure to biological fluids with potential exposure to infectious organisms.

Exposure to electrical office equipment.

Personal protective equipment required such as protective eyewear, garments and gloves.

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.

Frequent mobility required.

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 others will 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.

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.

Essential Functions: Manages allocated clinical studies according to timelines and quality standards. Coordinates activities of all functional departments and vendors involved in the project; in some cases the multi-functional project management lead will have to take direct responsibility for the clinical subspecialty functional area. 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, interim monitoring, CRF retrieval, CRF data entry, etc.). Ensures teams are entering and updating internal tracking tools e.g. Project Pulse, CASCADE, etc. 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 with 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 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 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 into hiring, performance 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. Attends bid defenses as necessary.

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 8 years’) or equivalent combination of education, training, & experience. Years of experience refers to typical years of related experience needed to gain the required knowledge, skills, and abilities necessary to perform the essential functions of the job. Years of experience are not to be used as the only determining factor in establishing the job class or making employment selection decisions.

Knowledge, Skills and Abilities:

Knowledge of the key principles of cross functional project management (Time, Quality, Cost).

Solid financial acumen.

Apply a range of negotiation techniques to achieve desired outcomes with evidence of commercial and organizational acumen.

Display effective communication skills (listening, oral, written) and can communicate in English language (oral and written).

Interpersonal skills and ability to adapt quickly to change.

Organized, proficient at multi-tasking with good attention to detail.

Able to lead, motivate and coordinate teams. Coach/mentor team members as appropriate.

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.

Possesses cross cultural awareness and is able to adapt appropriately.

Understanding and appreciation of clinical research/development, including

medical and therapeutic areas, phases and medical terminology.

Experience with leading, liaising and coordinating cross-functional project teams.

Knowledge/understanding of clinical development guidelines and directives.

Working Conditions and Environment:

Work is performed in an office/ laboratory and/or a clinical environment.

Exposure to biological fluids with potential exposure to infectious organisms.

Exposure to electrical office equipment.

Personal protective equipment required such as protective eyewear, garments and gloves.

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.

Frequent mobility required.

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 others will 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.

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.

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US-MD-Rockville-FSP Rockville MD, US-PA-Wayne-Wayne PA Devon Dr, US-PA-Collegeville-FSP Collegeville PA, US-FL-Orlando-Orlando FL, US-Minnesota-Minneapolis, US-PA-Horsham-Horsham PA 132 Welsh Rd #100, US-CA-San Diego-FSP San Diego, CA, US-Massachusetts, US-PA-Blue Bell-Blue Bell PA Harvest Dr, US-MA-Boston, US-Maryland, US-NY-New York, US-North Carolina, US-California, US-MA-Boston-FSP Boston MA, US-NC-Durham-FSP RTP NC Five Moore Drive, US-MA-Cambridge-FSP2 Cambridge, MA, US-KY-Highland Heights-Highland Heights KY Tesseneer, US-PA-Horsham-Horsham PA 2 Walnut Dr Ste 375, US-Kentucky, US-CA-San Carlos-FSP San Carlos CA, US-WI-Middleton-Middleton WI Deming Way, US-IL-Chicago, US-CA-South San Francisco-FSP San Francisco CA, US-NC-Durham, US-IL-North Chicago-FSP North Chicago, US-Arizona, US-NJ-Kenilworth-FSP Kenilworth NJ, US-CA-San Francisco-FSP2 San Francisco CA, US-PA-King of Prussia-FSP King of Prussia PA, US-Nevada, United States, US-MD-Rockville-Rockville MD Research Blvd, US-NJ-Basking Ridge-FSP Basking Ridge NJ, US-Michigan, US-Michigan-Detroit, US-CA-San Diego-San Diego CA Scranton Road, US-Washington, US-District of Columbia-Washington, DC, US-TX-Houston, US-New Jersey, US-MA-Devens-FSP Devens MA, US-NJ-Princeton-FSP Lawrenceville NJ, US-MA-Cambridge-FSP Cambridge MA, US-MD-Bethesda-Bethesda MD, US-District of Columbia, US-WA-Seattle-FSP3 Seattle, WA, US-WI-Middleton-Middleton WI Research Way, US-VA-Richmond-Richmond VA Dabney Rd, US-WA-Bothell-FSP Bothell WA, US-IL-Round Lake-FSP Roundlake IL, US-PA-Moon Township-FSP Moon Township PA FSP Dr, US-Texas, US-WA-Seattle-FSP2 Seattle, US-PA-Warminster-FSP Warminster PA, US-TX-Austin-Austin TX Metro Center Dr 200, US-Colorado, US-WA-Bothell, US-PA-Philadelphia-FSP2 Philadelphia, PA, US-Georgia, US-Illinois, US-FL-Ocala-Neurohealth, US-Colorado-Denver, US-WA-Seattle-FSP Seattle WA, US-Georgia-Atlanta, US-VA-Richmond, US-NJ-Princeton-Princeton, US-NY-East Syracuse-FSP Syracuse NY, US-PA-West Point-FSP West Point PA, US-NJ-Hamilton-Hamilton NJ Quakerbridge Rd, US-NJ-Summit-FSP Summit NJ, US-NV-Las Vegas-Las Vegas NVSubmission for the position: Clinical Project Manager (Contract Research Organization) - Contract Opportunity - (Job Number: 168167)