Cta Sponsor Dedicated Based in Lisbon
2 semanas atrás
TFS HealthScience is excited to be expanding our Strategic Resourcing Solution team and we are looking for an experienced, highly motivated Clinical Trial Associate (CTA) who shares our vision of providing clinical research excellence. Our Strategic Resourcing Solution team is a highly experienced international group of professionals led by an industry expert.
We are a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. We combine the full-service capabilities and global reach of a large CRO with the flexibility and personal approach only a mid-size CRO can deliver.
Our cores values of Trust, Quality, Flexibility and Passion are what makes TFS Healthscience the successful company it is today. Our values shape our culture and work ethic. They reflect what we stand for and guide our organization. Together we make a difference.
The Clinical Trial Associate (CTA) will work, when delegated, as a member of the study team with the responsibility to organize and maintain the Study Master File (SMF) and coordinate practical tasks during the study according to company policies, SOPs and regulatory requirements.
Key Responsibilities
- Assist Study Team with accurately, scanning, uploading, updating, and maintaining all TMF documents and systems (e.g., Trial Master File (TMF)) that track compliance of clinical sites and internal functional departments for performance within project timelines.
- Set up and maintenance of study information in Clinical Trial Management System (CTMS) as per delegation from PM/ Lead CRA or CRA.
- Assist with periodic review of study files for completeness.
- Assist in editing and formatting of documents in Word, Excel, and Power Point.
- Develop meeting agendas, minutes, and track follow-up actions.
- Maintain a vendor and site contact list.
- Other administrative tasks as assigned.
**Requirements**:
- Bachelor’s Degree
- 2+ years of experience in clinical research/drug development
- Understanding of FDA and ICH Guidelines, Good Clinical Practices (GCP), medical terminology, and clinical trials.
- Minimum 2 years direct experience managing TMF and clinical trial databases/systems.
- Computer skills including working knowledge of Microsoft Office Suite.
- Excellent written and verbal communication.
- Effective time management and organizational skills.
- Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
**Benefits**:
What can we offer you?
A great place to work where you will get the chance to push your career to the next level, global environment with global opportunities. You will also get the opportunity to be part of a team with highly intelligent, passionate experts from all over the world. TFS HealthScience is a place for inspiration where we focus on the patients, saving lives and aiming to increase their quality of life by supporting our clients. [enter country] benefits include:
- Competitive salary & benefits package
- Excellent career progression opportunities
- Great corporate culture and work life balance
TFS HealthScience collects and processes personal data in accordance with applicable data protection laws. If you are a European Job Applicant see the privacy notice for further details.
TFS HealthScience does not discriminate on the basis of race, sex, color, religion, age, national origin, marital status, disability, veteran status, genetic information, sexual orientation, gender identity or any other reason prohibited by law in provision of employment opportunities and benefits.
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