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Clinical Trial Coordinator II (Belgrade, Serbia)

Pharmaceutical Product Development (PPD)

RS-Belgrade

Clinical Trial Coordinator – Belgrade, Serbia

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. 

The team

Our clinical department defines, develops and delivers clinical programmes. We ensure the highest-quality review of data and effective interaction with study sites, including on-site monitoring throughout a study, ensuring that patients receive needed care, as well as identifying and treating clinical trial participants.

Main Responsibilities

The role provides administrative and technical support to the Project Team. Our colleagues coordinate, oversee and complete functions on assigned trials activities detailed on the task matrix. The main day-to-day tasks include but are not limited to:

· Performs of department, Internal, Country and Investigator file reviews as assigned and documents findings in appropriate system

· Ensures allocated tasks are performed on time, within budget and to a high-quality standard. Proactively communicates any risks to project leads.

· Supports the maintenance of study specific documentation and systems

· Provides system support (i.e. GoBalto & eTMF).

· Performs administrative tasks on assigned trials such as: timely processing of documents sent to Client (e)TMF as assigned, performing (e)TMF reviews, performing mass mailings and communications as needed, providing documents and reports to internal team members.

· Supports scheduling of client and/or internal meetings.

· Reviews and tracks local regulatory documents.

Clinical Trial Coordinator – Belgrade, Serbia

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. 

The team

Our clinical department defines, develops and delivers clinical programmes. We ensure the highest-quality review of data and effective interaction with study sites, including on-site monitoring throughout a study, ensuring that patients receive needed care, as well as identifying and treating clinical trial participants.

Main Responsibilities

The role provides administrative and technical support to the Project Team. Our colleagues coordinate, oversee and complete functions on assigned trials activities detailed on the task matrix. The main day-to-day tasks include but are not limited to:

· Performs of department, Internal, Country and Investigator file reviews as assigned and documents findings in appropriate system

· Ensures allocated tasks are performed on time, within budget and to a high-quality standard. Proactively communicates any risks to project leads.

· Supports the maintenance of study specific documentation and systems

· Provides system support (i.e. GoBalto & eTMF).

· Performs administrative tasks on assigned trials such as: timely processing of documents sent to Client (e)TMF as assigned, performing (e)TMF reviews, performing mass mailings and communications as needed, providing documents and reports to internal team members.

· Supports scheduling of client and/or internal meetings.

· Reviews and tracks local regulatory documents.

Requirements

If this sounds like you, you need to have:

Education:

Bachelor's degree in life-science is preferred, but not mandatory

Previous experience that provides the knowledge, skills and abilities to perform the job (comparable to 1 years)

Knowledge, skills and experience

· Ability to work in a team or independently as required

· Good organizational skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectively

· Demonstrated ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency

· Strong customer focus

· Flexibility to reprioritize workload to meet changing project timelines

· Demonstrated ability to attain and maintain a good working knowledge of applicable Country Regulations, ICH Good Clinical Practices, and organization/Client SOPs and WPDs for all non-clinical/clinical aspects of project implementation, execution and closeout

· Good English language and grammar skills and proficient local language skills as needed

· Good computer skills, proficient in MS Office (Word, Excel, and PowerPoint) and ability to obtain knowledge and master all clinical trial database systems

· Ability to successfully complete PPD clinical training program

· Self-motivated, positive attitude and good interpersonal skills

What we offer

At PPD we hire the best, develop ourselves and each other, and recognise 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 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 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 organisation but with a local feel.

You will receive an initial and ongoing training with the option to develop and build upon your skills. You will learn more about the industry and expand your knowledge on a global level.

Requirements

If this sounds like you, you need to have:

Education:

Bachelor's degree in life-science is preferred, but not mandatory

Previous experience that provides the knowledge, skills and abilities to perform the job (comparable to 1 years)

Knowledge, skills and experience

· Ability to work in a team or independently as required

· Good organizational skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectively

· Demonstrated ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency

· Strong customer focus

· Flexibility to reprioritize workload to meet changing project timelines

· Demonstrated ability to attain and maintain a good working knowledge of applicable Country Regulations, ICH Good Clinical Practices, and organization/Client SOPs and WPDs for all non-clinical/clinical aspects of project implementation, execution and closeout

· Good English language and grammar skills and proficient local language skills as needed

· Good computer skills, proficient in MS Office (Word, Excel, and PowerPoint) and ability to obtain knowledge and master all clinical trial database systems

· Ability to successfully complete PPD clinical training program

· Self-motivated, positive attitude and good interpersonal skills

What we offer

At PPD we hire the best, develop ourselves and each other, and recognise 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 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 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 organisation but with a local feel.

You will receive an initial and ongoing training with the option to develop and build upon your skills. You will learn more about the industry and expand your knowledge on a global level.

Job posted: 2020-11-05

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