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Project Assistant, Clinical Supplies

Pharmaceutical Product Development (PPD)

NC-Wilmington-Wilmington NC HQ

PPD’s mission is to improve health.

It starts as an idea to cure. It becomes a life saved. All in-between, it’s you!

We know that meaningful results not only require the right approach, but also the right people. We invite you to re-imagine health promoting protocols with us, working alongside bright and energetic teams.

As a Project Assistant, you will provide technical and administrative support to your assigned clinical project team.You work with a high attention to detail, reviewing documentation, coordinating project details, and maintaining data systems - all with a sense of urgency aligned with that of our customers.

Responsibilities include, but are not limited to;Reviews regulatory documents for proper contentPerforms PPD investigator file reviews and logging of outstanding issues in project related tracking toolsLiaises with monitor and investigative sites to resolve outstanding regulatory issues identifiedDisseminates study related information, including project tracking updates to Clients, clinical study teams and other PPD departmentsAssists with the identification of potential investigators and development/distribution of initial protocol packetsCreates meeting agendas and minutesCoordinates team conference calls and distribution of meeting minutes

PPD’s mission is to improve health.

It starts as an idea to cure. It becomes a life saved. All in-between, it’s you!

We know that meaningful results not only require the right approach, but also the right people. We invite you to re-imagine health promoting protocols with us, working alongside bright and energetic teams.

As a Project Assistant, you will provide technical and administrative support to your assigned clinical project team.You work with a high attention to detail, reviewing documentation, coordinating project details, and maintaining data systems - all with a sense of urgency aligned with that of our customers.

Responsibilities include, but are not limited to;Reviews regulatory documents for proper contentPerforms PPD investigator file reviews and logging of outstanding issues in project related tracking toolsLiaises with monitor and investigative sites to resolve outstanding regulatory issues identifiedDisseminates study related information, including project tracking updates to Clients, clinical study teams and other PPD departmentsAssists with the identification of potential investigators and development/distribution of initial protocol packetsCreates meeting agendas and minutesCoordinates team conference calls and distribution of meeting minutes

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 abilitiesKnowledge, Skills and Abilities:Excellent communication and interpersonal skillsExcellent organizational skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectivelyAbility to effectively analyze project specific data/systems to ensure accuracy and efficiencyFlexibility to reprioritize workload to meet changing project timelinesResponsible 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 closeoutExcellent English and grammar skillsExcellent computer skills, proficient in MS Word, Excel, PowerPoint and ability to obtain knowledge and master all clinical trial database systemsAbility to successfully complete PPD clinical training program (CAFT- Clinical Administration Foundation Training)Ability to mentor and train new Project Assistants as neededPPD 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 mannerAble to work upright and stationary for typical working hoursAbility to use and learn standard office equipment and technology with proficiencyAble to perform successfully under pressure while prioritizing and handling multiple projects or activitiesMay 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 abilitiesKnowledge, Skills and Abilities:Excellent communication and interpersonal skillsExcellent organizational skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectivelyAbility to effectively analyze project specific data/systems to ensure accuracy and efficiencyFlexibility to reprioritize workload to meet changing project timelinesResponsible 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 closeoutExcellent English and grammar skillsExcellent computer skills, proficient in MS Word, Excel, PowerPoint and ability to obtain knowledge and master all clinical trial database systemsAbility to successfully complete PPD clinical training program (CAFT- Clinical Administration Foundation Training)Ability to mentor and train new Project Assistants as neededPPD 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 mannerAble to work upright and stationary for typical working hoursAbility to use and learn standard office equipment and technology with proficiencyAble to perform successfully under pressure while prioritizing and handling multiple projects or activitiesMay require travel (Recruiter will provide more details)

Job posted: 2020-05-26

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