Clinical Trial Assistant (m/f)
Company
Mithra (Euronext: MITRA) is a Belgian biotech company dedicated to transforming Women’s Health by offering new choices through innovation, with a particular focus on contraception and menopause. Mithra’s goal is to develop products offering better efficacy, safety and convenience, meeting women’s needs throughout their life span. Its three lead development candidates are built on Mithra’s unique native estrogen platform, Estetrol (E4): Estelle®, a new era in oral contraception, PeriNesta®, the first complete oral treatment targeting perimenopause and Donesta®, the next-generation hormone therapy. Mithra also develops and manufactures complex therapeutics in the areas of contraception, menopause and hormone-dependent cancers. It offers partners a complete spectrum of research, development and specialist manufacturing at its technological platform Mithra CDMO.
Active in more than 100 countries around the world, Mithra has an approximate headcount of 250 staff members and is headquartered in Liège, Belgium
Description
Mithra is looking for a Clinical Trial Assistant to join its Clinical department (R&D) at Mithra headquarter in Liège.
Mission
As « Clinical Trial Assistant » you are part of the clinical team. You will provide administrative support to the clinical team members for the conduct of studies from a pharma company perceptive. The clinical assistant job includes a wide variety of duties and responsibilities that allow a smooth flow of the clinical trial process. This is an excellent opportunity for ambitious individuals who are willing to gain exposure in the Clinical Research field and to work for a growing company.
Duties and responsibilities
- Provide administrative support to clinical team (incl. co-ordinating and organizing appointments and meetings, ordering study specific supplies, making travel arrangements for clinical staff members)
- Set-up and maintain the sponsor TMF, including essential clinical study documents, email correspondence, training materials and other study related documents
- Coordinate the reception of the third party documents and file them in the sponsor TMF
- Maintain and update the information in the company system for clinical tracking purposes
- Track incoming and outgoing clinical and regulatory documents and provide updates for the clinical team members
- Support the clinical team in preparing study documents
- Support the clinical team in monitoring clinical trials by producing key performance indicators
- Coordinate completion and execution of contracts (vendor agreements) and trial related insurances
- Provide support to clinical team in the management of study budgets and invoicing (incl. invoice tracking, ERP update)
- Manage central inbox, file and distribute accurate messages to appropriate team members
- Create, maintain and update information into clinical public database
- Prepare and attend clinical team meetings, generate and distribute meeting minutes to the clinical team members
- Follow standard operating procedures
Profile
- Bachelor’s degree (or equivalent), preferably in a scientific discipline
- Relevant experience in an administrative work environment, with experience in support of clinical research project teams for a CRO or pharmaceutical/biotech company
- Strong proficiency in the use of Microsoft Office products, including Word, Excel, PowerPoint and Outlook
- Demonstrable experience of working to high quality standards and resolving issues
- Very good written and verbal communication skills (including English)
- Ability to be flexible and adaptable in the face of changing priorities and ambiguous environments very good organizational skills
- Ability to manage time and work independently
What we offer
Varied and motivating responsibilities within a fast growing company.
An attractive salary package in line with your experience.
Application
Send your CV and application letter to: belgium.job@mithra.com.
Your email must mention following subject: MITHRA-CTA-022021
Recruitment Agencies, please refrain from contacting us or sending us CVs on a spontaneous