Optimization Associate Director / Director - Study Start Up services (remote)

Submission for the position: Optimization Associate Director / Director - Study Start Up services (remote) - (Job Number: 172765)

About PPD:

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.

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 Associate Director is part of our Process and Systems Optimization team within the Site and Patient Access division at PPD- which handles our Study Start up activities for clinical trials. This role provides oversight for the development and implementation of innovative solutions to complex cross-functional operational issues requiring extensive collaboration and cooperation across global functions.

The position is accountable for highly complex initiatives aimed at supporting and ensuring quality operational delivery through 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:Identifies process improvement opportunities within the Site and Patient Access (SPA) division and mentors team members. Interprets data on complex issues, leads cross-functional project teams and makes good business decisions with minimal support.

Designs, develops, communicates and implements process optimizing strategies for SPA 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 SPA initiatives teams to develop, optimize and improve processes, associated systems/applications, training and communications.Leads and/or participates in multiple large, complex SPA 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.Performs special projects, assignments and administrative tasks per business needs.Provides mentorship, guidance, support and training to staff and coaches team members in developing and implementing process improvement initiatives.

About PPD:

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.

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 Associate Director is part of our Process and Systems Optimization team within the Site and Patient Access division at PPD- which handles our Study Start up activities for clinical trials. This role provides oversight for the development and implementation of innovative solutions to complex cross-functional operational issues requiring extensive collaboration and cooperation across global functions.

The position is accountable for highly complex initiatives aimed at supporting and ensuring quality operational delivery through 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:Identifies process improvement opportunities within the Site and Patient Access (SPA) division and mentors team members. Interprets data on complex issues, leads cross-functional project teams and makes good business decisions with minimal support.

Designs, develops, communicates and implements process optimizing strategies for SPA 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 SPA initiatives teams to develop, optimize and improve processes, associated systems/applications, training and communications.Leads and/or participates in multiple large, complex SPA 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.Performs special projects, assignments and administrative tasks per business needs.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 skillsPPD 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 travel

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’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 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 skillsPPD 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 travel

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’d love to hear from you.Submission for the position: Optimization Associate Director / Director - Study Start Up services (remote) - (Job Number: 172765)