Optimization Director- Site and Patient Access

About the Department:

Our goal-driven teams combine and deliver startup activities for the clinical trials, collaborating to improve processes, cycle and flexibility. We partner with our sites, businesses and colleagues around the world to decrease startup timelines and exceed expectations.

About the Position:

The Optimization AD (or Director / Sr Director), sitting within the S&PA function, provides oversight for the development and implementation of innovative solutions to highly complex cross-functional operational issues requiring extensive collaboration and cooperation across functions and/or with other business units to address.

He/she is accountable for assigned, highly complex initiatives aimed at supporting and ensuring quality operational delivery via efficient and effective processes, associated systems, training and communications.

About our Culture, Career Advancement and Benefits:

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 well-being of our employees.

Job Description:

The role will require significant change management experience at functional and globallevels withinPPD. Implementing new systems experience is ideal.Will be responsible for increasing Oracle system adoption, compliance and quality management and developing a change enable management team via change management training program and establishment of change champion network.

Designs, develops, communicates and implements process optimizing strategies to best support business outcomes and industry compliance requirements. Proactively collaborates with senior management to identify and drive continuous process optimization. Consults with executive sponsors and key stakeholders in support of initiatives teams to develop, optimize and improve processes, associated systems/applications, training and communications. Leads and/or participates in multiple large, complex process improvement initiatives and/or governance committees. Independently and skillfully develops process improvement processes and solutions. Reviews, assesses and manages updates to cross-functional/over-arching procedural documents for overall compliance with current processes. Acts as an Authorizing Manager for CAPAs. Identifies training needs, and then develops and/or approves training materials. Makes recommendations required to prioritize business process improvement needs. Responds to client or internal process audits on processes, systems, or procedures. Provides mentorship, guidance, support and training to staff and coaches team members in developing and implementing process improvement initiatives

About the Department:

Our goal-driven teams combine and deliver startup activities for the clinical trials, collaborating to improve processes, cycle and flexibility. We partner with our sites, businesses and colleagues around the world to decrease startup timelines and exceed expectations.

About the Position:

The Optimization AD (or Director / Sr Director), sitting within the S&PA function, provides oversight for the development and implementation of innovative solutions to highly complex cross-functional operational issues requiring extensive collaboration and cooperation across functions and/or with other business units to address.

He/she is accountable for assigned, highly complex initiatives aimed at supporting and ensuring quality operational delivery via efficient and effective processes, associated systems, training and communications.

About our Culture, Career Advancement and Benefits:

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 well-being of our employees.

Job Description:

The role will require significant change management experience at functional and globallevels withinPPD. Implementing new systems experience is ideal.Will be responsible for increasing Oracle system adoption, compliance and quality management and developing a change enable management team via change management training program and establishment of change champion network.

Designs, develops, communicates and implements process optimizing strategies to best support business outcomes and industry compliance requirements. Proactively collaborates with senior management to identify and drive continuous process optimization. Consults with executive sponsors and key stakeholders in support of initiatives teams to develop, optimize and improve processes, associated systems/applications, training and communications. Leads and/or participates in multiple large, complex process improvement initiatives and/or governance committees. Independently and skillfully develops process improvement processes and solutions. Reviews, assesses and manages updates to cross-functional/over-arching procedural documents for overall compliance with current processes. Acts as an Authorizing Manager for CAPAs. Identifies training needs, and then develops and/or approves training materials. Makes recommendations required to prioritize business process improvement needs. Responds to client or internal process audits on processes, systems, or procedures. Provides mentorship, guidance, support and training to staff and coaches team members in developing and implementing process improvement initiatives

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 12-15 years).

Significant clinical research experience in all phases of clinical study life cycle, including start-up, interim and close-out, is preferred.

Knowledge, Skills and Abilities: Solid leadership and project management skills Excellent judgment, decision making, escalation and risk management skills Advanced process improvement skills Exceptional investigative and analytical skills Excellent interpersonal and negotiation skills In-depth understanding of clinical management technology and systems, and excellent computer skills Thorough understanding of the practices, processes, and requirements of clinical trials Broad understanding of procedural documents Effective oral and written communication skills including the ability to communicate in English, both orally and in writing Capable of directing and promoting teamwork in a multi-disciplinary and/or multi-cultural team setting Capable of thinking strategically and cross-functionally Excellent attention to detail In-depth understanding of regulatory guidelines and directives Excellent creative and critical thinking skills

Management Role: No Management Responsibility

PPD values the health and well-being 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 minimal as-needed travel (0-10%)

PPD Defining Principles:

- We have a strong will to win - We earn our customer’s trust - We are game changers - 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 would 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 12-15 years).

Significant clinical research experience in all phases of clinical study life cycle, including start-up, interim and close-out, is preferred.

Knowledge, Skills and Abilities: Solid leadership and project management skills Excellent judgment, decision making, escalation and risk management skills Advanced process improvement skills Exceptional investigative and analytical skills Excellent interpersonal and negotiation skills In-depth understanding of clinical management technology and systems, and excellent computer skills Thorough understanding of the practices, processes, and requirements of clinical trials Broad understanding of procedural documents Effective oral and written communication skills including the ability to communicate in English, both orally and in writing Capable of directing and promoting teamwork in a multi-disciplinary and/or multi-cultural team setting Capable of thinking strategically and cross-functionally Excellent attention to detail In-depth understanding of regulatory guidelines and directives Excellent creative and critical thinking skills

Management Role: No Management Responsibility

PPD values the health and well-being 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 minimal as-needed travel (0-10%)

PPD Defining Principles:

- We have a strong will to win - We earn our customer’s trust - We are game changers - 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 would love to hear from you.