Project Mgr - PPAS Technology Solutions

Summarized Purpose: Serves as the Project Lead and primary contact for technology solution deployment. Accountable for the overall delivery of the technology solution deployment (quality, time, cost) on behalf of the organization. Acts as th e technology and vendor management liaison, escalation contact and subject matter expert for between the operational and scientific teams on behalf of the technology vendors, ensuring proper communication, deliverables, assessment of risks and timely escalations. Establishes and communicates internal and external customer expectations related to the technology solution to the project team with minimal direction. Ensures that escalation pathways are adhered to internally and externally. Responsible for the oversight of all technology-related aspects during start-up and, if required, provide additional support during study conduct and close-out.

Essential Functions: Serves as the primary contact for the internal and external customers for technology solution deployment at the project level. Works with major practice area and 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. Ensures escalation pathways adhered to internally and externally (Rules of Engagement –communication pathways) Drives and owns the overall delivery of technology solution deployment (time, cost, quality) Ensures financial stewardship at a project level by demonstrating an intimate understanding of the contract, resource alignment to budget, management of Out of Scope activity, drive the Con Mod process/negotiations and team execution to timelines as it relates to technology solution deployment. 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 Establishes, communicates and manages internal and external customer expectations to achieve optimal technology solution deployment delivery during the project. Drives Risk Identification and Issue Resolution at project level specific to the technology solution deployment (RBQM/RESOLVE). Ensures project team compliance with organization policies, SOPs, ICH-GCP, regulatory and project specific requirements for the technology solution deployment. Contributes to process improvement initiatives. Communicates with internal and external customers regularly to obtain direction and feedback on implementing scope of work as well as performance to date. Identifies unusual or significant problems encountered during the course of a study and proposes strategies for preventing or correcting significant problems. Pe rf orm s stu dy spe c i f i c in f orma l te stin g, c rea te s a n d re v iew s stu d y spe c if i c s u pport guideli n e s f or a c c u r a c y a n d c omp le te n e ss. If applicable, provides information to an authorizing manager for CAPAs

Job Complexity: Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors

Job Knowledge: Having wide-ranging experience, uses professional concepts and company objectives to resolve complex issues in creative and effective ways. Some barriers to entry exist at this level (e.g., dept. / peer review). Level at which career may plateau.

Supervision Received: Determines methods and procedures on new assignments and may coordinate activities of other personnel (i.e., Team Lead). Exercises judgment in selecting methods, techniques and evaluation criteria obtaining results.

Business Relationships: Frequent contacts with internal personnel and outside customer representatives at various management levels concerning operations or scheduling of specific phases of projects or contracts. Creates formal networks with key contacts outside own area of expertise.

Summarized Purpose: Serves as the Project Lead and primary contact for technology solution deployment. Accountable for the overall delivery of the technology solution deployment (quality, time, cost) on behalf of the organization. Acts as th e technology and vendor management liaison, escalation contact and subject matter expert for between the operational and scientific teams on behalf of the technology vendors, ensuring proper communication, deliverables, assessment of risks and timely escalations. Establishes and communicates internal and external customer expectations related to the technology solution to the project team with minimal direction. Ensures that escalation pathways are adhered to internally and externally. Responsible for the oversight of all technology-related aspects during start-up and, if required, provide additional support during study conduct and close-out.

Essential Functions: Serves as the primary contact for the internal and external customers for technology solution deployment at the project level. Works with major practice area and 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. Ensures escalation pathways adhered to internally and externally (Rules of Engagement –communication pathways) Drives and owns the overall delivery of technology solution deployment (time, cost, quality) Ensures financial stewardship at a project level by demonstrating an intimate understanding of the contract, resource alignment to budget, management of Out of Scope activity, drive the Con Mod process/negotiations and team execution to timelines as it relates to technology solution deployment. 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 Establishes, communicates and manages internal and external customer expectations to achieve optimal technology solution deployment delivery during the project. Drives Risk Identification and Issue Resolution at project level specific to the technology solution deployment (RBQM/RESOLVE). Ensures project team compliance with organization policies, SOPs, ICH-GCP, regulatory and project specific requirements for the technology solution deployment. Contributes to process improvement initiatives. Communicates with internal and external customers regularly to obtain direction and feedback on implementing scope of work as well as performance to date. Identifies unusual or significant problems encountered during the course of a study and proposes strategies for preventing or correcting significant problems. Pe rf orm s stu dy spe c i f i c in f orma l te stin g, c rea te s a n d re v iew s stu d y spe c if i c s u pport guideli n e s f or a c c u r a c y a n d c omp le te n e ss. If applicable, provides information to an authorizing manager for CAPAs

Job Complexity: Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors

Job Knowledge: Having wide-ranging experience, uses professional concepts and company objectives to resolve complex issues in creative and effective ways. Some barriers to entry exist at this level (e.g., dept. / peer review). Level at which career may plateau.

Supervision Received: Determines methods and procedures on new assignments and may coordinate activities of other personnel (i.e., Team Lead). Exercises judgment in selecting methods, techniques and evaluation criteria obtaining results.

Business Relationships: Frequent contacts with internal personnel and outside customer representatives at various management levels concerning operations or scheduling of specific phases of projects or contracts. Creates formal networks with key contacts outside own area of expertise.

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 and relevant combination of education, training, & experience.

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.

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: Technical and systems competency, such as computer skills, to include effective use of systems and applications such as Microsoft Outlook, Word, Excel and PowerPoint, as well as organization systems (CTMS, Preclarus, Clarity) Knowledge of the software development lifecycle including the development, validation, translation and migration (paper to electronic) process. Hands-on knowledge of primary platforms used in clinical study space, not limited to: CTMS, EDC, eCOA platforms In-depth PPAS area knowledge and clinical development and regulatory guidelines and requirements. Ability to independently scope various types of business-specific technology implementation projects and develop projects plans and requirements documents Ability to quickly assess and document critical and essential business needs and determine the best implementation strategies supporting the most efficient, long-term technical solutions and enhanced processes. Hands-on experience with systems integrations, business analysis, business and technical requirements gathering, assessment of data files structure Proactive, solutions oriented and adaptable in changing priorities and situations Advanced knowledge of the key principles of project management (Time, Quality, Cost) Strong financial acumen. Good judgment and decision-making skills and proven ability to apply critical and analytical strategic thinking skills to manage complex/ambiguous situations Effective oral and written communication skills including the ability to communicate in English, both orally and in writing. Excellent interpersonal skills and problem-solving ability. Effective organization and negotiation skills. Strong customer service skills with the ability to proactively address and prioritize expectations Possesses depth of knowledge and practical application of budgeting, forecasting and resource management. A relationship builder who is able to work effectively in matrix organizations. Demonstrates strong leadership skills. Demonstrates cultural awareness and adapts appropriately. Knowledge of medical terminology. Knowledge of general data management and data minding functions, used in clinical space Applies a range of negotiation techniques to achieve desired outcomes with evidence of commercial and organizational acumen. Ability to work independently with minimal supervision

Management Role (if desired): No management responsibility

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.

Percent Billable: 80% -100%

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 and relevant combination of education, training, & experience.

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.

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: Technical and systems competency, such as computer skills, to include effective use of systems and applications such as Microsoft Outlook, Word, Excel and PowerPoint, as well as organization systems (CTMS, Preclarus, Clarity) Knowledge of the software development lifecycle including the development, validation, translation and migration (paper to electronic) process. Hands-on knowledge of primary platforms used in clinical study space, not limited to: CTMS, EDC, eCOA platforms In-depth PPAS area knowledge and clinical development and regulatory guidelines and requirements. Ability to independently scope various types of business-specific technology implementation projects and develop projects plans and requirements documents Ability to quickly assess and document critical and essential business needs and determine the best implementation strategies supporting the most efficient, long-term technical solutions and enhanced processes. Hands-on experience with systems integrations, business analysis, business and technical requirements gathering, assessment of data files structure Proactive, solutions oriented and adaptable in changing priorities and situations Advanced knowledge of the key principles of project management (Time, Quality, Cost) Strong financial acumen. Good judgment and decision-making skills and proven ability to apply critical and analytical strategic thinking skills to manage complex/ambiguous situations Effective oral and written communication skills including the ability to communicate in English, both orally and in writing. Excellent interpersonal skills and problem-solving ability. Effective organization and negotiation skills. Strong customer service skills with the ability to proactively address and prioritize expectations Possesses depth of knowledge and practical application of budgeting, forecasting and resource management. A relationship builder who is able to work effectively in matrix organizations. Demonstrates strong leadership skills. Demonstrates cultural awareness and adapts appropriately. Knowledge of medical terminology. Knowledge of general data management and data minding functions, used in clinical space Applies a range of negotiation techniques to achieve desired outcomes with evidence of commercial and organizational acumen. Ability to work independently with minimal supervision

Management Role (if desired): No management responsibility

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.

Percent Billable: 80% -100%