Job Description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

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.

Discover Impactful Work:

As a Project Support Coordinator/ TMF Support Coordinator, you will provide administrative and technical support to project teams by filing documents in PPD’s eTMF and/or client eTMFs.

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:

Provides administrative and technical support to project teams by filing documents in PPD’s eTMF and/or client eTMFs

• Liaises with project and functional leads, clinical operations staff, and other relevant team members to facilitate document collection and retention
• Reviews study-related or essential documents for completeness and compliance with protocol and relevant regulations
• Tracks and/or pushes down documents in CTMS (as required) and manages electronic eTMF study documents
• Performs quality checks, files documents in PPD’s eTMF at study, country, and site levels and promotes documents to a status of “Approved”
• Classifies and indexes eTMF documentation with accurate attributes and metadata according to department standards
• Identifies and records quality issues, communicating with colleagues globally regarding errors in documents, providing solutions and resolving issues, as appropriate
• Compiles and distributes eTMF metrics reports to Project Leads and team members for assigned studies and follows up on issues noted
• Provides systems (e.g., CTMS, SharePoint & eTMF) support by managing access requests within the centralized filing support team
• Files documents in client eTMFs as specified by a study’s eTMF plan

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).
• 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.
• 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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