Project Assistant Ii, Clinical Supplies
hace 2 semanas
PPD is a leading global contract research organization. At PPD we are passionate, deliberate, and driven by our purpose - to improve health.
PPD’s Clinical Management department is committed to industry leadership and the relentless pursuit of excellence. Working in the Clinical Management department, you will combine deep knowledge, therapeutic expertise, and robust tools to help our clients deliver life-changing therapies to market.
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.
Grow within the Clinical Management department into senior-level Project Assistant roles or leadership roles within the department. Or, develop into Remote Site Monitor or Clinical Research Associate roles. You can also explore opportunities within other groups, such as Site and Patient Access.
The basic purpose of the Project Assistant is to provide technical support to the project team. Will coordinate non-clinical responsibilities of project administration as applicable to the client contract under the direction of the assigned Clinical Manager or Sr. Clinical Manager.
Responsibilities include, but are not limited to;
- Reviews regulatory documents for proper content
- Performs PPD investigator file reviews and logging of outstanding issues in project related tracking tools
- Liaises with monitor and investigative sites to resolve outstanding regulatory issues identified
- Disseminates study related information, including project tracking updates to Clients, clinical study teams and other PPD departments
- Assists with the identification of potential investigators and development/distribution of initial protocol packets
- Creates meeting agendas and minutes
- Coordinates 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 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
At PPD clinical research services we hire the best, develop ourselves and each other, and recognize the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD clinical research services you will benefit from an award-winning learning and development programme, ensuring you reach your potential.
As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD clinical research services truly value a work-life balance. We’ve grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organization but with a local feel.
Our 4i Values:
Integrity - Innovation - Intensity - Involvement
LI-KC2
LI-REMOTE
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