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About the role
Key responsibilities & impact- Support day-to-day management of studies, ensure within the Study Team that project/study tasks are delivered in time, within the budget, and according to Sponsor/Client expectations, in close cooperation with designated Project Team
- Support the implementation and maintenance of studies; assist so that Sponsor and Investigator obligations are met and are in compliance with applicable regulatory requirements (including local law) as well as Good Clinical Practice
- Support in document management (creation, review, collection, filing, forwarding) including submission documents, meeting minutes and Trial Master Files, from Pre-study Phase to Study Closure
- Support (field) monitors by (but not limited to) preparing checklists, controlling completion status and timelines, updating relevant tracking sheets
- Create, review, finalize, forward and file meeting minutes for all internal and external study-related meetings.
- Support in Celerion process improvement
- Support in-house in performing site feasibility and site qualification visits in order to select qualified sites
- Support to prepare documents for Site Initiation Visits (SIVs), such as presentation slides
- Support to prepare documents for Monitoring Visits
- Support to prepare documents for Close-out Visits
- Perform content review and quality checks of received documents
- Cooperate with central TMF team to keep Trial Master File (TMF) up-to-date and track filed documents
- Support query resolution in a timely manner
- Support Serious Adverse Event (SAE) reporting according to study specifications
- Support in document/review study status, site enrolment status
- As a member of Celerion’s project teams, perform billable work in accordance with Celerion BCDs, SOPs and PGs, and within the relevant timelines
- Interact with Sponsor/Client and participate in Sponsor/Client meetings as necessary
- Participate and demonstrate proactive involvement in project/study meetings, internal project/study meetings, and other activities enhancing project progress
- Participate in audits and inspections, including preparation and follow-up activities
- Support Sponsor/Client in fulfilling their obligations with regard to submissions according to relevant regulatory requirements
Requirements
What you’ll need- Bachelor’s degree in a biomedical-related field, life sciences or equivalent field
- Excellent oral and written communication skills in English
- High level of organization, multi-tasking, judgement and analytical skills
- Good time management skills to ensure adherence to timelines
- Profound knowledge of Good Clinical Practice, 21 CRF Part 11, and other relevant regulatory requirements
- Dedication to quality and reliability
- Commitment to continuous training and knowledge sharing; proactively keeping up to date with procedural industry standards and international regulatory developments in clinical research
- Ability to work well independently and as part of a team
- Maintain confidentiality of Subject data and Sponsor/Client information
- Computer literate
- Pay attention to detail, be tactful, and diplomatic
- Responds to client needs and is focused on client satisfaction
- Willingness to learn and gain professional experience
Benefits
Comp & perks- Celerion Values: Integrity
- Trust
- Teamwork
- Respect
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
document managementquality checkssite feasibilitysite qualificationSerious Adverse Event reportingproject managementregulatory complianceGood Clinical Practice21 CFR Part 11analytical skills
Soft Skills
communication skillsorganizationmulti-taskingjudgementtime managementattention to detailtactfulnessdiplomacyclient satisfactionteamwork