Study Start Up Director (client oversight- remote)

Submission for the position: Study Start Up Director (client oversight- remote) - (Job Number: 188786)

About PPD:

PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. At PPD, we are passionate, deliberate, and driven by our purpose- to improve health!

About the Department:

In Study Start Up, our goal-driven teams combine and deliver startup activities for 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 Study Start Up Director is a client oversight role that provides subject matter expertise and consulting, including global project leadership to ensure effective operations, delivery of site activation targets and the implementation of systems, process and policies for the group. This role collaborates with global business leads cross-functionally to achieve project goals.

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 Director role provides strategic direction and fosters a high-performance culture through leadership. Ensures that individual project targets are met, clients aresatisfied and services are provided with the highest quality standards and policies and procedures arefollowed. Cultivates strategic relationships globally and acts a representative across the function andclient groups. Contributes to and/or leads initiatives and strategies across the function or organization tooptimize service delivery. Ensures the timely and customer-focused execution of site activation with afocus on quality deliverables for assigned projects. Demonstrates leadership and expertise in supporting, developing and driving thespecific and overall site activation strategies to ensure optimum performance andachievement of project plans and targets. Facilitates site intelligence and activation planning/kick-off meetings to identifypotential risks and work with the project team to develop and communicatecontingency plans. Ensures project risks and potential contingencies impacting time/quality/cost ofdeliverables are discussed with Senior Management through appropriateescalation pathways. Reviews and assesses team profitability through the identification of “out ofscope” activity in a timely manner and supporting follow through on all aspectsof contract modification. Communicates with sponsor(s) regularly to obtain direction and feedback onimplementing scope of work as well as performance to date. Pro-activelyidentifies unusual or significant problems encountered during the course of aclinical trial and proposes and implements strategies for preventing or correctingsignificant problems. Participates in business development activities as needed Provides ongoing mentorship, coaching and feedback to operational teamsand/or staff associated with portfolios

#LI-NA1

#LI-remote

About PPD:

PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. At PPD, we are passionate, deliberate, and driven by our purpose- to improve health!

About the Department:

In Study Start Up, our goal-driven teams combine and deliver startup activities for 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 Study Start Up Director is a client oversight role that provides subject matter expertise and consulting, including global project leadership to ensure effective operations, delivery of site activation targets and the implementation of systems, process and policies for the group. This role collaborates with global business leads cross-functionally to achieve project goals.

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 Director role provides strategic direction and fosters a high-performance culture through leadership. Ensures that individual project targets are met, clients aresatisfied and services are provided with the highest quality standards and policies and procedures arefollowed. Cultivates strategic relationships globally and acts a representative across the function andclient groups. Contributes to and/or leads initiatives and strategies across the function or organization tooptimize service delivery. Ensures the timely and customer-focused execution of site activation with afocus on quality deliverables for assigned projects. Demonstrates leadership and expertise in supporting, developing and driving thespecific and overall site activation strategies to ensure optimum performance andachievement of project plans and targets. Facilitates site intelligence and activation planning/kick-off meetings to identifypotential risks and work with the project team to develop and communicatecontingency plans. Ensures project risks and potential contingencies impacting time/quality/cost ofdeliverables are discussed with Senior Management through appropriateescalation pathways. Reviews and assesses team profitability through the identification of “out ofscope” activity in a timely manner and supporting follow through on all aspectsof contract modification. Communicates with sponsor(s) regularly to obtain direction and feedback onimplementing scope of work as well as performance to date. Pro-activelyidentifies unusual or significant problems encountered during the course of aclinical trial and proposes and implements strategies for preventing or correctingsignificant problems. Participates in business development activities as needed Provides ongoing mentorship, coaching and feedback to operational teamsand/or staff associated with portfolios

#LI-NA1

#LI-remote

Education and Experience: Bachelor's degree or equivalent and relevant formal academic / vocational qualification Previous clinical research experience that provides the knowledge, skills, and abilities to perform the job (comparable to12 years).

Knowledge, Skills and Abilities: Advanced strategic thinking, planning and organization skills Capable of analyzing data, anticipating and mitigating risk, exercising sound judgment, problemsolving and decision-making working while under pressure and at times with limited desiredinformation Skilled at using personal influence and persuasion to effectively promote ideas and proposals toshape stakeholder opinions Capable of developing and cultivating strong internal/external networks of contacts and resources toensure operational execution Proven skills in building relationship and working effectively in matrix environments Excellent change management skills to influence and motivate, demonstrating excellent interpersonaland conflict resolution skills Demonstrated credible leadership style with ability to mobilize and foster team productivity Capable of motivating managers and supervisors to define and reach team objectives Profiecient in budgeting, forecasting and resource management Superior concise and well-organized oral and written communication skills including the ability tocommunicate in English Extremely efficient, well-organized and demonstrates a strong attention to detail Excellent computer skills, particularly word processing and spreadsheets (MS Word and MS Excel) Deep understanding of study start-up operations in a global environment Extensive understanding of FDA, GCP, and ICH guidelines with a track record of successfuloperational delivery

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 as-needed travel (0-20%)

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 clinical research experience that provides the knowledge, skills, and abilities to perform the job (comparable to12 years).

Knowledge, Skills and Abilities: Advanced strategic thinking, planning and organization skills Capable of analyzing data, anticipating and mitigating risk, exercising sound judgment, problemsolving and decision-making working while under pressure and at times with limited desiredinformation Skilled at using personal influence and persuasion to effectively promote ideas and proposals toshape stakeholder opinions Capable of developing and cultivating strong internal/external networks of contacts and resources toensure operational execution Proven skills in building relationship and working effectively in matrix environments Excellent change management skills to influence and motivate, demonstrating excellent interpersonaland conflict resolution skills Demonstrated credible leadership style with ability to mobilize and foster team productivity Capable of motivating managers and supervisors to define and reach team objectives Profiecient in budgeting, forecasting and resource management Superior concise and well-organized oral and written communication skills including the ability tocommunicate in English Extremely efficient, well-organized and demonstrates a strong attention to detail Excellent computer skills, particularly word processing and spreadsheets (MS Word and MS Excel) Deep understanding of study start-up operations in a global environment Extensive understanding of FDA, GCP, and ICH guidelines with a track record of successfuloperational delivery

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 as-needed travel (0-20%)

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: Study Start Up Director (client oversight- remote) - (Job Number: 188786)