Work Schedule
Other
Environmental Conditions
Office
Job Description
At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.
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Discover Impactful Work:
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 project documentation and systems by managing access requests, tracking project level documents and maintaining electronic trial master file audit readiness by conducting regular file reviews.
Office, Flex and Remote work options are available. Remote employees based in Sofia will be expected to visit the office regularly (around 2-3 times a week) for a period of 3 to 6 months to ensure successful onboarding and adaptation. Our friendly team would like to meet you and ensure you feel truly welcome and supported!
Job 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. Brings up 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.
- 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.
Education:
- Bachelor's degree/High/Secondary school diploma or equivalent and relevant formal academic/vocational qualification.
Experience:
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 1 year).
Knowledge, Skills, Abilities:
- Excellent command of English - verbal and written.
- Working Knowledge of computer systems including Microsoft Word, Excel, Outlook and PowerPoint (or equivalent).
- Knowledge of Italian, German, Dutch, Spanish or French at B1 or above level is considered an advantage
- 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 track record 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.
- Strong customer focus and good interpersonal skills.
- Effective oral and written communication skills.
Work Environment:
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.
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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