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Project Assistant - Global Clinical Supplies- Customer-dedicated, Ghent

Pharmaceutical Product Development (PPD)

BE-Belgium

Submission for the position: Project Assistant - Global Clinical Supplies- Customer-dedicated, Ghent - (Job Number: 178063)

Project Assistant, Global Clinical Supplies – Customer-Dedicated

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.

Our Global Clinical Supplies team cover all aspects from purchasing to global inventory management and from distribution to destruction.

PPD are looking for a Project Assistant to join our team, the role can be based anywhere in EMEA and be dedicated to one of our customers, fully integrated with their systems & SOPs.

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 and tracks local regulatory documents, handles wet-ink documents as required per study/sponsor specifications. May transmit documents to client and centralized IRB/IEC eTMF/Project file set-up (Central and Internal files). Submits documents to eTMF. Analyzes and reconciles project documents, metrics and findings reports within specified timelines. Processes local payments (translations, EC/IEC, other local vendors, etc.) Performs mass mailings and communication as needed. Maintains vendor trackers. Provides accesses to company, client and vendor systems. Assists with study-specific translation materials and translation QC upon request. Assists with clarification and resolution of findings related to site documentation. Maintains assigned data points within CTMS according to the established conventions within specified times, including entry of findings Assists on project management ad-hoc activities, produces reports, assists on study plans edition. Coordinates team conference calls, completes and distributes meeting minutes from internal/client/vendor meetings as applicable Provides ad hoc support as needed.

In addition to the standard PA activities you will also be involved in: Procurement activities Tracking of drug supplies Forecasting drug requirements

Project Assistant, Global Clinical Supplies – Customer-Dedicated

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.

Our Global Clinical Supplies team cover all aspects from purchasing to global inventory management and from distribution to destruction.

PPD are looking for a Project Assistant to join our team, the role can be based anywhere in EMEA and be dedicated to one of our customers, fully integrated with their systems & SOPs.

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 and tracks local regulatory documents, handles wet-ink documents as required per study/sponsor specifications. May transmit documents to client and centralized IRB/IEC eTMF/Project file set-up (Central and Internal files). Submits documents to eTMF. Analyzes and reconciles project documents, metrics and findings reports within specified timelines. Processes local payments (translations, EC/IEC, other local vendors, etc.) Performs mass mailings and communication as needed. Maintains vendor trackers. Provides accesses to company, client and vendor systems. Assists with study-specific translation materials and translation QC upon request. Assists with clarification and resolution of findings related to site documentation. Maintains assigned data points within CTMS according to the established conventions within specified times, including entry of findings Assists on project management ad-hoc activities, produces reports, assists on study plans edition. Coordinates team conference calls, completes and distributes meeting minutes from internal/client/vendor meetings as applicable Provides ad hoc support as needed.

In addition to the standard PA activities you will also be involved in: Procurement activities Tracking of drug supplies Forecasting drug requirements

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

- We have a strong will to win - We earn our customer’s trust - We are gamechangers - 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.

Please note that due to the high volume of applications, only short-listed candidates will be contacted.

PPD is an equal employer.

*LI-MP1

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

- We have a strong will to win - We earn our customer’s trust - We are gamechangers - 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.

Please note that due to the high volume of applications, only short-listed candidates will be contacted.

PPD is an equal employer.

*LI-MP1 Submission for the position: Project Assistant - Global Clinical Supplies- Customer-dedicated, Ghent - (Job Number: 178063)

Job posted: 2021-04-02

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