Project Manager - Investigator Initiated Studies - FSP Team

Submission for the position: Project Manager - Investigator Initiated Studies - FSP Team - (Job Number: 183798)

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 Project Delivery team directs, coordinates and manages the technical and operational aspects of projects, securing the successful completion of clinical trials. We collaborate with functional area leads to identify and evaluate fundamental issues on the project and ensure that solutions are implemented.

Responsibilities:

• Manage all aspects of assigned program including Medical Affairs Company Sponsored Studies (MACS), Investigator Initiated Research (IIR), and Externally Sponsored Collaborative Clinical Research studies for Gastroenterology therapeutic area and product programs.

• Manage clientand product level study budgets and communicate study activities to internal stakeholders.

• Oversee and manage the activities of Global Medical Evidence (GME), including the initiation, tracking, completion, and reporting of studies in accordance with all applicable internal legal and compliance policies (SOPs) as well as external regional and country specific regulatory guidelines.

• May serve as the therapeutic operational area lead for interfacing with internal stakeholders (e.g. GMA, Region and LOC medical leads, ClientMedical Heads, alliance partners, etc.) and external investigators to develop and execute research plans and budgets.

• Oversee and/or facilitate receipt, processing, and internal cross-functional review of internal/external study submissions

• Review and compile materials for discussion and approval by client review committee, including study concepts and protocols, meeting minutes, and investigator communications.

• Coordinate required cross-functional review meetings to review, approve, and track studies and ensure proper documentation and archiving (minutes, team communications, etc.) of review outcomes.

• Coordinate the capture, archiving and reporting of appropriate study level information (including patient safety information).

• Oversee and/or facilitate the management of the internal CTMS, iEnvision and document repositories per Medical Affairs SOPs and processes.

• Coordinate with Pharmacovigilance and Regulatory Affairs to respond to external audits and requests from external regulatory bodies.

• Contribute to pre- fair market value (FMV) evaluation of proposed study budget and oversee the conduct of FMV assessments of budgets submitted for approved studies in accordance with Takeda policies and procedures.

• Coordinate budget forecasting, accruals and tracking insystem.

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 wellbeing of our employees.

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 Project Delivery team directs, coordinates and manages the technical and operational aspects of projects, securing the successful completion of clinical trials. We collaborate with functional area leads to identify and evaluate fundamental issues on the project and ensure that solutions are implemented.

Responsibilities:

• Manage all aspects of assigned program including Medical Affairs Company Sponsored Studies (MACS), Investigator Initiated Research (IIR), and Externally Sponsored Collaborative Clinical Research studies for Gastroenterology therapeutic area and product programs.

• Manage clientand product level study budgets and communicate study activities to internal stakeholders.

• Oversee and manage the activities of Global Medical Evidence (GME), including the initiation, tracking, completion, and reporting of studies in accordance with all applicable internal legal and compliance policies (SOPs) as well as external regional and country specific regulatory guidelines.

• May serve as the therapeutic operational area lead for interfacing with internal stakeholders (e.g. GMA, Region and LOC medical leads, ClientMedical Heads, alliance partners, etc.) and external investigators to develop and execute research plans and budgets.

• Oversee and/or facilitate receipt, processing, and internal cross-functional review of internal/external study submissions

• Review and compile materials for discussion and approval by client review committee, including study concepts and protocols, meeting minutes, and investigator communications.

• Coordinate required cross-functional review meetings to review, approve, and track studies and ensure proper documentation and archiving (minutes, team communications, etc.) of review outcomes.

• Coordinate the capture, archiving and reporting of appropriate study level information (including patient safety information).

• Oversee and/or facilitate the management of the internal CTMS, iEnvision and document repositories per Medical Affairs SOPs and processes.

• Coordinate with Pharmacovigilance and Regulatory Affairs to respond to external audits and requests from external regulatory bodies.

• Contribute to pre- fair market value (FMV) evaluation of proposed study budget and oversee the conduct of FMV assessments of budgets submitted for approved studies in accordance with Takeda policies and procedures.

• Coordinate budget forecasting, accruals and tracking insystem.

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 wellbeing of our employees.

Education, Behavioral Competencies and Skills:

• Bachelor’s degree required, preferably in a health sciences related field with 3 years of research related experience and/or pharmaceutical industry experience.

• Proven track record of project management

• Ability to communicate and interact thoughtfully, transparently, and appropriately with a variety of clients both internal and external to client.

Desired:

• Research experience (health sciences related), Pharmaceutical Industry including CRO

• Experience working in a global organization highly desirable.

PPD values the health and wellbeing 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.

Able to work in non-traditional work environments.

Able 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 have exposure to potentially hazardous elements typically found in healthcare or laboratory environments.

This role requires independent travel up to 10%, inclusive of traveling in automobiles, airplanes, and trains.

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, Behavioral Competencies and Skills:

• Bachelor’s degree required, preferably in a health sciences related field with 3 years of research related experience and/or pharmaceutical industry experience.

• Proven track record of project management

• Ability to communicate and interact thoughtfully, transparently, and appropriately with a variety of clients both internal and external to client.

Desired:

• Research experience (health sciences related), Pharmaceutical Industry including CRO

• Experience working in a global organization highly desirable.

PPD values the health and wellbeing 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.

Able to work in non-traditional work environments.

Able 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 have exposure to potentially hazardous elements typically found in healthcare or laboratory environments.

This role requires independent travel up to 10%, inclusive of traveling in automobiles, airplanes, and trains.

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: Project Manager - Investigator Initiated Studies - FSP Team - (Job Number: 183798)