Clinical Review Specialist - FSP Team

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 position:

This exciting opportunity is to support our client located in Northbrook, IL.Ideal candidate will have 2 years of multi-country Clinical Trialsexperience. Must haveknowledge of protocol and clinical drug development process, clinical study design, study planning and management, and monitoring. Project Management skills required.

Reviews patient data in accordance with Good Clinical Practice (GCP), Standard Operating Procedures (SOPs)/Working Practice Documents (WPDs) and Data Validation Manuals (DVMs). Clinical Review Specialists will be expected to liaise with colleagues in other functional groups as required, and to communicate with management for all data review activities within their allocated studies.

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.

Job Description:

Support the study team 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 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; identify and escalate issues that arise during study conduct; Participate in development of study plans and system set-up,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 Support and effectively manage interactions with vendor study team Support 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. Support study team members for study deliverables

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 position:

This exciting opportunity is to support our client located in Northbrook, IL.Ideal candidate will have 2 years of multi-country Clinical Trialsexperience. Must haveknowledge of protocol and clinical drug development process, clinical study design, study planning and management, and monitoring. Project Management skills required.

Reviews patient data in accordance with Good Clinical Practice (GCP), Standard Operating Procedures (SOPs)/Working Practice Documents (WPDs) and Data Validation Manuals (DVMs). Clinical Review Specialists will be expected to liaise with colleagues in other functional groups as required, and to communicate with management for all data review activities within their allocated studies.

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.

Job Description:

Support the study team 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 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; identify and escalate issues that arise during study conduct; Participate in development of study plans and system set-up,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 Support and effectively manage interactions with vendor study team Support 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. Support study team members for study deliverables

Education and Experience:

BA/BS degree with at least two years of multi-country clinical trial experience

Pharma experience desired.

Knowledge of protocol and clinical drug development processes, clinical study design, study planning and management, and monitoring.

Project Management skills.

Knowledge, Skills and Abilities:

Excellent computer skills, to include effective use of systems and applications such as Microsoft Outlook, Word, Excel and PowerPoint, as well as PPD systems (CTMS, Preclarus, Clarity)

Solid attention to detail and process focused

Effective oral and written communication skills

Proactive and results-driven

Attentive to stakeholder needs

Good organizational, time management and planning skills to coordinate multiple projects and changing priorities

Basic therapeutic area awareness

Good understanding of the key principles of project management (time, quality, cost), including basic financial acumen

Management Role:

No management responsibility

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 and Experience:

BA/BS degree with at least two years of multi-country clinical trial experience

Pharma experience desired.

Knowledge of protocol and clinical drug development processes, clinical study design, study planning and management, and monitoring.

Project Management skills.

Knowledge, Skills and Abilities:

Excellent computer skills, to include effective use of systems and applications such as Microsoft Outlook, Word, Excel and PowerPoint, as well as PPD systems (CTMS, Preclarus, Clarity)

Solid attention to detail and process focused

Effective oral and written communication skills

Proactive and results-driven

Attentive to stakeholder needs

Good organizational, time management and planning skills to coordinate multiple projects and changing priorities

Basic therapeutic area awareness

Good understanding of the key principles of project management (time, quality, cost), including basic financial acumen

Management Role:

No management responsibility

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.