Clinical Trials Administrator
- Full-time
- Department: Clinical Trial Administration
Company Description
PrimeVigilance (part of Ergomed Group), is a specialised mid-size pharmacovigilance service provider 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 has become one of the global leaders in its field. We cover all therapy areas including medical device.
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
·Attends project training sessions according to project and/or Sponsor requirements.
May assist with TMF set up and maintenance activities as needed under supervision of the appointed PM/CTM. Works with project teams to assist in tracking, naming and routing of clinical trial documentation to the Trial Master File (TMF), in accordance with the applicable Ergomed PM SOP or Sponsor SOP on Study Document Filing.
Maintains contact lists, information for project team members (e.g. project training records) and other trackers as required. Provides reports from tracking tools and other ad-hoc reports/trackers as requested.
Qualifications
Administrative work experience, preferably in an international Clinical Research setting
Ability to plan, multitask and work in a dynamic team environment
Excellent computer skills, including proficiency in MS Office (Word, Excel, PowerPoint, Office, Project)
Additional Information
We offer excellent chances to progress and develop. We work on a global basis on interesting projects within rare diseases, oncology, and neurology. This is an ideal position to continue developing a career in clinical drug development.
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 Ergomed is a great company to join!
Quality
Integrity & Trust
Drive & Passion
Agility & Responsiveness
Belonging
Collaborative Partnerships
We look forward to welcoming your application.
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