Assoc Project Manager - FSP team - Biosamples

Pharmaceutical Product Development (PPD)

IL-North Chicago-FSP North Chicago


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.

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.

The Associate Project Manager drives and owns a sub-set of project-specific activities as directed by the Project Lead. Provides ownership related to the compilation of tasks to support overall delivery of the project (quality, time, cost)

Job Description:

•Responsible for Biomarker Operations oversightfor client's sponsored and supported trials. Plan, organize and oversee the collection and shipping of Biosamples from investigator sites or central labs. Ensure timely delivery and optimal quality. Work with timelines and internal resource needs for Biosample operational activities.

•Collaborate with Biosample leaders, Oncology Biomarker department, Project Managers, vendors, Sr. BOM Program Leader, Biomarker Scientist, and SMT as required.

•Involvement in clinical protocol review.

•Owns a sub-set of project tasks as deputized by the Project Lead to support the cross-functional delivery of the project.

•Creates, tracks and updates project plans.

•Compiles project reports and status updates.

•Coordinates and leads internal & external (if needed) project team meetings.

•Contributes to the day-to-day management of project finances including performing financial analyses, updates and provides required follow-up with functional leads when necessary.

•Owns vendor management activity.

•Brings together information from internal project functions to coordinate the execution of project deliverables.

•Manages and coordinates cross-functional gathering of information for the project Risk Register (from initiation to closure).

•Maintains compliance with all organization policies , SOPs , ICH-GCP, regulatory and project specific requirements.

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.

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.

The Associate Project Manager drives and owns a sub-set of project-specific activities as directed by the Project Lead. Provides ownership related to the compilation of tasks to support overall delivery of the project (quality, time, cost)

Job Description:

•Responsible for Biomarker Operations oversightfor client's sponsored and supported trials. Plan, organize and oversee the collection and shipping of Biosamples from investigator sites or central labs. Ensure timely delivery and optimal quality. Work with timelines and internal resource needs for Biosample operational activities.

•Collaborate with Biosample leaders, Oncology Biomarker department, Project Managers, vendors, Sr. BOM Program Leader, Biomarker Scientist, and SMT as required.

•Involvement in clinical protocol review.

•Owns a sub-set of project tasks as deputized by the Project Lead to support the cross-functional delivery of the project.

•Creates, tracks and updates project plans.

•Compiles project reports and status updates.

•Coordinates and leads internal & external (if needed) project team meetings.

•Contributes to the day-to-day management of project finances including performing financial analyses, updates and provides required follow-up with functional leads when necessary.

•Owns vendor management activity.

•Brings together information from internal project functions to coordinate the execution of project deliverables.

•Manages and coordinates cross-functional gathering of information for the project Risk Register (from initiation to closure).

•Maintains compliance with all organization policies , SOPs , ICH-GCP, regulatory and project specific requirements.

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 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 5 years).

In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities:

•Clinical development experience of working in teams running human clinical studies (phases I-IV), monitoring clinical studies or working at an investigator site.

•Proven clinical/biological labratory experience, involvement in processing and/or analysis of biological samples.

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

•Solid attention to detail and process focused

•Strong oral and written communication skills

•Proactive and results oriented, including ability to be attentive to stakeholder needs

•Basic therapeutic area knowledge

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

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

•Basic financial understanding/awareness

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:

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 5 years).

In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities:

•Clinical development experience of working in teams running human clinical studies (phases I-IV), monitoring clinical studies or working at an investigator site.

•Proven clinical/biological labratory experience, involvement in processing and/or analysis of biological samples.

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

•Solid attention to detail and process focused

•Strong oral and written communication skills

•Proactive and results oriented, including ability to be attentive to stakeholder needs

•Basic therapeutic area knowledge

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

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

•Basic financial understanding/awareness

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.


2021-02-23 00:00:00


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