Clinical Trial Assistant

Posted 4 Days Ago
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Belgrade, Belgrade City, Central Serbia, SRB
In-Office
Entry level
Biotech • Pharmaceutical
The Role
The Clinical Trial Assistant supports clinical trials through administrative duties, manages project meetings, maintains documentation, and ensures compliance with trial processes.
Summary Generated by Built In
Company Description

We are PrimeVigilance (part of Ergomed group), a specialised mid-size pharmacovigilance service provider initially established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical Information, Pharmacovigilance, Regulatory Affairs and Quality Assurance.  

PrimeVigilance provides first class support to our small to large pharmaceutical and biotechnology partners maintaining long lasting relationships and becoming one of the global leaders in its fields. We cover all therapy areas including medical devices.  

We love investing in our staff by providing an excellent training and development platform. We value employee experience, well-being and mental health and we acknowledge that a healthy work life balance is a critical factor for employee satisfaction and in turn nurtures an environment from which a high-quality client service can be achieved.  

Come and join us in this exciting journey to make a positive impact in patient’s lives.   

Job Description

  • Carries out assigned administrative duties to support clinical trial conduct
  • Sets up Investigator Site File, according to SOPs provided either by the Sponsor or by ERGOMED, and distribute to sites
  • Coordinates and attends project meetings (e.g. investigator, kick-off, team, etc.) with the PM/CTM. Supports preparation of meeting agenda and provides written high-quality meeting minutes within specified timeframe
  • Works with project teams to assist in tracking, naming and routing of clinical trial documentation to the Trial Master File (TMF)
  • Maintains contact lists, information for project team members (e.g. project training records) and other trackers as required. Provides reports from tracking tools. 
  • If requested attends in-house audits and supports completion of Corrective and Preventative Action Plan 
  • Any other task related to the specific clinical trial performance

Qualifications

  • High school diploma or equivalent or adequate experience in the field of clinical research
  • Excellent English oral and written communication skills 
  • Excellent computer skills, including proficiency in MS Office (Word, Excel, PowerPoint, Office, Project)
  • Administrative work experience, preferably in an international Clinical Research setting

  • Ability to plan, multitask and work in a dynamic team environment

Additional Information

Why PrimeVigilance  

We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders and ages can contribute and grow.   

To succeed we must work together with a human first approach. Why? because our people are our greatest strength leading to our continued success on improving the lives of those around us.  

We offer:  

  • Training and career development opportunities internally   

  • Strong emphasis on personal and professional growth  

  • Friendly, supportive working environment  

  • Opportunity to work with colleagues based all over the world, with English as the company language  

Our core values are key to how we operate, and if you feel they resonate with you then PrimeVigilance could be a great company to join!   

  • Quality  

  • Integrity & Trust   

  • Drive & Passion   

  • Agility & Responsiveness   

  • Belonging  

  • Collaborative Partnerships   

Come and join us in this exciting journey to make a positive impact in patient’s lives. We look forward to welcoming your application.  

Top Skills

Excel
Ms Office (Word
Office
PowerPoint
Project)
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The Company
HQ: Raleigh, NC
535 Employees
Year Founded: 1997

What We Do

Founded in 1997, Ergomed is a global provider of high-quality services to the biopharmaceutical industry, spanning all phases of clinical trials, post-approval pharmacovigilance, and medical information. Ergomed’s fast-growing services business includes an industry-leading suite of specialist pharmacovigilance (PV) solutions, integrated under the PrimeVigilance brand, and Ergomed Clinical Research, a complete, global Phase I-IV clinical development and trial management services with a strong heritage in the development of drugs in rare diseases and oncology. • 1,400+ highly qualified professionals • Global full-service CRO • 25+ years of experience • Therapeutic specialization in oncology • Strong expertise in rare disease trials • Robust clinical safety system • Choice of leading drug safety databases Our key services include: • Clinical Research Services • Pharmacovigilance • Medical Information • Regulatory • Medical Writing • Site Management • Study Physician Support • Biostatistics • Patient Study Support

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