Project Support Coordinator with Italian/German/Spanish/French/Dutch
Work from home
full-time

Project Support Coordinator with Italian/German/Spanish/French/Dutch

Work from home full-time

About us

PPD clinical research servicess mission is to improve health. It starts as an idea to cure. It becomes a life saved. All in-between, its 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 our talented, bright and energetic teams.
Due to the constant expansion of our global centralized functions in Sofia were opening opportunities for professionals within the Project Support Services group in the role of Project Support Coordinator. Intermediate fluency in Italian, German, Spanish, Dutch or French is required.
Office, Flex or Remote work options are available to all candidates, including those outside of Sofia.

Summarized Purpose:

As a Project Support Coordinator, you will provide administrative and technical support to project teams including planning, organizing and coordinating responsibilities at a global level with supervision (as required) of the operational activities. You will assist with initial setup, ongoing maintenance of various systems, data entry completion and maintenance of database repositories. The role assists in preparing reports and data collection for analysis. You will also support audit readiness by ensuring files are reviewed on schedule, as detailed in the organization's SOPs/Client specific guidance document. You will support the maintenance of project specific documentation and systems by managing access requests, tracking project level documents and maintaining electronic trial master file audit readiness by conducting regular file reviews.

Responsibilities

Coordinates, oversees and completes functions on assigned trials activities detailed on the task matrix.
Performs 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. Escalates in cases of variances (overburn/underburn).
Supports the maintenance of study specific documentation and systems including, but not limited to: study team lists, tracking of project specific training requirements, system access management, and tracking of project level activity plans in appropriate system.
Provides system (i.e. CTMS, Oracle Activate & eTMF) support by managing the access requests, tracking study level documents and maintaining audit readiness.
Performs administrative tasks on assigned trials including, but not limited to: timely processing of documents sent to PPD's/Client eTMF as required, performing PPD's/Client eTMF reviews, performing mass mailings and communications as needed, providing documents and reports to internal team members.
Supports scheduling and organization of client and/or internal meetings with completion and distribution of related meeting minutes.
Exports and prepares study metrics reports.
Maintains vendor trackers.
Assists with coordination and compilation of Investigator Site File (ISF) template and pharmacy binder, with instruction from the Clinical Team Manager.
When required attends Kick off and Project Launch meetings and takes notes, supports initial study set-up.

Requirements and necessary skills

Required Education/Experience:
Bachelor's degree/High/Secondary school diploma or equivalent and relevant formal academic/vocational qualification.
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 1 year).

Knowledge, Skills and Abilities Required:

Excellent command of English verbal and written.
Knowledge of Italian, German, Dutch, Spanish or French at B2 or above level is required.
Good computer skills, proficient in MS Office (Word, Excel, and PowerPoint) and ability to obtain knowledge and learn the required clinical trial systems.
Ability to work in a team or independently as required.
Good organizational and time management skills as well as strong attention to detail with proven ability to handle multiple tasks efficiently and effectively.
Flexibility and adaptability to provide efficient support while meeting tight project timelines.
Ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency.
Demonstrated ability to attain and maintain a good working knowledge of applicable Country Regulations (if required), ICH Good Clinical Practices, and organization/Client SOPs and WPDs for all non-clinical/clinical aspects of project implementation, execution and closeout.
Strong customer focus and good interpersonal skills.
Effective oral and written communication skills.

We offer

What We Offer
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. Weve 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
If you resonate with our 4i values above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the worlds most urgent health needs, submit your application wed love to hear from you!

PPD clinical research services is now part of Thermo Fisher Scientific. As the world leader in serving science, our Mission is to enable our customers to make the world healthier, cleaner and safer. We are excited about the opportunities this combination brings to enhance our comprehensive end-to-end offering, enabling customers to move rapidly from scientific idea to approved medicine.

Diversity Statement (will be automatically populated in Taleo)
PPD is proud to be an affirmative action employer that values diversity as a strength and fosters an environment of mutual respect. PPD is committed to providing equal employment opportunities without regard to age, race, color, pregnancy, national origin, religion, sex, gender identity, sexual orientation, disability, veteran status or status within any other protected group.
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