Senior Project Manager - FSP Team

This exciting opportunity is to support our client located in Northbrook, IL.Ideal candidate will have 5 years of multi-country Clinical Trialsexperience. Must have strong knowledge of protocol and clinical drug development process, clinical study design, study planning and management, and monitoring. Project Management and study leadership skills required.

PPD is a leading global contract research organization. At PPD we are passionate, deliberate, and driven by our purpose - to improve health. We partner directly with our clients to deliver projects from study start-up through close-out activities. In Project Management, you will oversee the delivery of PPD groups collaborating to support our clients. In short, you are a crucial piece in earning the trust of our clients.

As a Senior Project Manager, you are responsible for the overall management and successful delivery of the clinical study from start-up through close-out activities. You often work globally, with multi-functional leads to anticipate problems, find solutions and deliver results. You lead the collaboration that shows our clients we are one team focused on our purpose, mission, and strategy.

Responsibilities:

Manage and lead the day-to-day operations of assigned studies to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements Manage and lead cross-functional study teams, including vendors Provide accurate and up-to-date study information within CTMS and other relevant tracking systems and provide regular updates of study progression to Clinical Program Management and other stakeholders; proactively identify and resolve issues that arise during study conduct; manage escalation of study-related issues Lead development of study plans and system set-up; participate in preparation and ensure operational excellence of protocol, CRF, CSR and other key study team deliverables Implement appropriate systems, standards and processes to ensure quality at the level of investigative sites, vendors and data Lead preparation of vendor requirements and project scope and selection of study vendors; effectively manage interactions with vendor study team Lead feasibility assessment and selection of countries and sites for study conduct Oversee the clinical aspects of timely data cleaning, data analysis and the availability of top line results; participate in data reviews and review of statistical analysis plans Ensure set-up and implementation of effective investigator and site monitor training; coordinate operational and therapeutic area training for internal and external study team members. Provide oversight and direction to study team members for study deliverables AssistClinical Study Managers and Clinical Study Associates for assigned studies

Grow within Project Management with opportunities to advance to Associate Director and Director within Project Management. Or grow your career in other departments across PPD.

At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. It's not just talk - our award winning training programs speak for themselves. To learn how PPD can advance your career, apply now! What To Expect Next We look forward to receiving your application. A member of our talent acquisition team will review your qualifications and if interested, you will be contacted for an interview. This exciting opportunity is to support our client located in Northbrook, IL.Ideal candidate will have 5 years of multi-country Clinical Trialsexperience. Must have strong knowledge of protocol and clinical drug development process, clinical study design, study planning and management, and monitoring. Project Management and study leadership skills required.

PPD is a leading global contract research organization. At PPD we are passionate, deliberate, and driven by our purpose - to improve health. We partner directly with our clients to deliver projects from study start-up through close-out activities. In Project Management, you will oversee the delivery of PPD groups collaborating to support our clients. In short, you are a crucial piece in earning the trust of our clients.

As a Senior Project Manager, you are responsible for the overall management and successful delivery of the clinical study from start-up through close-out activities. You often work globally, with multi-functional leads to anticipate problems, find solutions and deliver results. You lead the collaboration that shows our clients we are one team focused on our purpose, mission, and strategy.

Responsibilities:

Manage and lead the day-to-day operations of assigned studies to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements Manage and lead cross-functional study teams, including vendors Provide accurate and up-to-date study information within CTMS and other relevant tracking systems and provide regular updates of study progression to Clinical Program Management and other stakeholders; proactively identify and resolve issues that arise during study conduct; manage escalation of study-related issues Lead development of study plans and system set-up; participate in preparation and ensure operational excellence of protocol, CRF, CSR and other key study team deliverables Implement appropriate systems, standards and processes to ensure quality at the level of investigative sites, vendors and data Lead preparation of vendor requirements and project scope and selection of study vendors; effectively manage interactions with vendor study team Lead feasibility assessment and selection of countries and sites for study conduct Oversee the clinical aspects of timely data cleaning, data analysis and the availability of top line results; participate in data reviews and review of statistical analysis plans Ensure set-up and implementation of effective investigator and site monitor training; coordinate operational and therapeutic area training for internal and external study team members. Provide oversight and direction to study team members for study deliverables AssistClinical Study Managers and Clinical Study Associates for assigned studies

Grow within Project Management with opportunities to advance to Associate Director and Director within Project Management. Or grow your career in other departments across PPD.

At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. It's not just talk - our award winning training programs speak for themselves. To learn how PPD can advance your career, apply now! What To Expect Next We look forward to receiving your application. A member of our talent acquisition team will review your qualifications and if interested, you will be contacted for an interview. Qualifications: Education and Experience: Bachelor's degree or licensed certified health care training or equivalent combination of education and experience Has an in-depth understanding and extensive experience working within clinical development (equivalent to five years). This could include specific experience in a particular functional area Can demonstrate experience successfully managing and/or leading large groups or teams Experience using project management software Solid understanding of how to craft and manage a project budget Must possess a valid passport, as appropriate Knowledge, Skills and Abilities: BA/BS degree with at least five years multi-country clinical trial experience or advanced degree (MS/PhD/PharmD) with at least 3 years clinical trial experience Pharma experience desired Must have strong knowledge of protocol and clinical drug development processes, clinical study design, study planning and management, and monitoring. Requires proven project management skills and study leadership ability. Must have excellent interpersonal, written and verbal communication skills, administrative skills and computer ability. Must have strong knowledge of ICH/GCP guidelines. Fluent in English. Moderate (25%) travel required.

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 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 travel (Recruiter will provide more details) Qualifications: Education and Experience: Bachelor's degree or licensed certified health care training or equivalent combination of education and experience Has an in-depth understanding and extensive experience working within clinical development (equivalent to five years). This could include specific experience in a particular functional area Can demonstrate experience successfully managing and/or leading large groups or teams Experience using project management software Solid understanding of how to craft and manage a project budget Must possess a valid passport, as appropriate Knowledge, Skills and Abilities: BA/BS degree with at least five years multi-country clinical trial experience or advanced degree (MS/PhD/PharmD) with at least 3 years clinical trial experience Pharma experience desired Must have strong knowledge of protocol and clinical drug development processes, clinical study design, study planning and management, and monitoring. Requires proven project management skills and study leadership ability. Must have excellent interpersonal, written and verbal communication skills, administrative skills and computer ability. Must have strong knowledge of ICH/GCP guidelines. Fluent in English. Moderate (25%) travel required.

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 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 travel (Recruiter will provide more details)