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Project Manager Assistant - Sample Management

Pharmaceutical Product Development (PPD)

KY-Highland Heights-Highland Heights KY Tessenee

Position summary:

The Project Manager Assistant - Sample Managementis accountable for overall performance ofsample storage and client satisfaction by meeting the needs and expectations during the clinical trial. Provides internal consulting on Sample Management issues and identifies opportunities for process and efficiency improvements. Acts as the chief liaison to the operational and/or specimen management personnel of Sponsors/Biotech and is responsible for large study programs. Supports Sample Management group objectives through leadership and development and prepares and maintains process documents.

Essential Functions and Responsibilities: 35% Provides coordination of sample management, including but not limited to long-term storage, batch testing studies, and/or studies which involve sample storage only. Interacts with Sponsor/Biotech Specimen Management and other personnel to proactively address needs and expectations to support continued 30% Interacts with internal departments to ensure successful execution of the study. Leads assigned study Risk Assessment Meetings (RAMs). Monitors study budget. 20% Coordinates and provides specialized reports and/or metrics to Sponsor/Biotech Specimen Management and other personnel. Interacts with IT and Data Management for development of new software. 15% Interacts with Sample Management leadership team to ensure SM deliverables are met. Authors, reviews, and implements procedures.

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.

Position summary:

The Project Manager Assistant - Sample Managementis accountable for overall performance ofsample storage and client satisfaction by meeting the needs and expectations during the clinical trial. Provides internal consulting on Sample Management issues and identifies opportunities for process and efficiency improvements. Acts as the chief liaison to the operational and/or specimen management personnel of Sponsors/Biotech and is responsible for large study programs. Supports Sample Management group objectives through leadership and development and prepares and maintains process documents.

Essential Functions and Responsibilities: 35% Provides coordination of sample management, including but not limited to long-term storage, batch testing studies, and/or studies which involve sample storage only. Interacts with Sponsor/Biotech Specimen Management and other personnel to proactively address needs and expectations to support continued 30% Interacts with internal departments to ensure successful execution of the study. Leads assigned study Risk Assessment Meetings (RAMs). Monitors study budget. 20% Coordinates and provides specialized reports and/or metrics to Sponsor/Biotech Specimen Management and other personnel. Interacts with IT and Data Management for development of new software. 15% Interacts with Sample Management leadership team to ensure SM deliverables are met. Authors, reviews, and implements procedures.

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 equivalent combination of education, training, and experience that provides the individual with the required knowledge, skills, and abilities Knowledge, Skills and Abilities: Excellent communication and interpersonal skills Excellent organizational skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectively Ability to effectively analyze project specific data/systems to ensure accuracy and efficiency Flexibility to reprioritize workload to meet changing project timelines Responsible for adhering to FDA Good Clinical Practices, FDA regulations, PPD/Client Standard Operating Procedures and Working Practice Documents regulations for all non-clinical/clinical aspects of project implementation, execution, and closeout Excellent English and grammar skills Excellent computer skills, proficient in MS Word, Excel, PowerPoint and ability to obtain knowledge and master all clinical trial database systems Ability to successfully complete PPD clinical training program (CAFT- Clinical Administration Foundation Training) Ability to mentor and train new Project Assistants as needed 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 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 travel (Recruiter will provide more details)

Qualifications: Education and Experience: Bachelor's Degree or equivalent combination of education, training, and experience that provides the individual with the required knowledge, skills, and abilities Knowledge, Skills and Abilities: Excellent communication and interpersonal skills Excellent organizational skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectively Ability to effectively analyze project specific data/systems to ensure accuracy and efficiency Flexibility to reprioritize workload to meet changing project timelines Responsible for adhering to FDA Good Clinical Practices, FDA regulations, PPD/Client Standard Operating Procedures and Working Practice Documents regulations for all non-clinical/clinical aspects of project implementation, execution, and closeout Excellent English and grammar skills Excellent computer skills, proficient in MS Word, Excel, PowerPoint and ability to obtain knowledge and master all clinical trial database systems Ability to successfully complete PPD clinical training program (CAFT- Clinical Administration Foundation Training) Ability to mentor and train new Project Assistants as needed 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 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 travel (Recruiter will provide more details)

Job posted: 2021-02-11

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