Clinical Trials Manager
Location: NetherlandsThe Company
Our client is active in the field of clinical-stage, discovering and developing therapies targeting a rare disease. They carry their own line of products which they create themselves. A dynamic and upcoming biotech company with an open culture and an innovative drive.Role Description
The clinical trial manager will be responsible for phase II trial and upcoming new trials for 2020. International sites are based in North-West Europe. It's a varied role where you will be able to build up clinical research, site selection and vendor management. You will be the only person that carries out CT-work within the organisation. Close contact with C-level and reports directly to the CEO.Responsibilities
You are responsible for managing current and upcoming new clinical trials, executed in compliance with ICH/GCP guidelines. You will assist in vendor activities and sites (pre-study site evaluation and new site initiations) and build relationships. Ensuring quality and resolution of site-related issues by reviewing monitoring reports is key in this job. Furthermore you will develop and follow a framework of SOP development to ensure the company will maximize the value and benefits.Requirements
- MD or MSc degree in Biomedical Sciences or related area- At least 5 years of relevant work experience in clinical trial management in a pharmaceutical or CRO environment
- Experience with phase I - III in rare diseases
- Excellent verbal and written communication in English, Dutch is a pré
- Working knowledge of ICH/GCP regulations and clinical protocols
- Experience in vendor- and site management
Other information
- Ability to travel up to 10 - 20%- Accommodates a flexible work schedule according to clinical trial(s) priorities
- Perform job duties with minimal supervision and guidance
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Bram Reulen.
Opis stanowiska
The Company
Our client is active in the field of clinical-stage, discovering and developing therapies targeting a rare disease. They carry their own line of products which they create themselves. A dynamic and upcoming biotech company with an open culture and an innovative drive.Role Description
The clinical trial manager will be responsible for phase II trial and upcoming new trials for 2020. International sites are based in North-West Europe. It's a varied role where you will be able to build up clinical research, site selection and vendor management. You will be the only person that carries out CT-work within the organisation. Close contact with C-level and reports directly to the CEO.Responsibilities
You are responsible for managing current and upcoming new clinical trials, executed in compliance with ICH/GCP guidelines. You will assist in vendor activities and sites (pre-study site evaluation and new site initiations) and build relationships. Ensuring quality and resolution of site-related issues by reviewing monitoring reports is key in this job. Furthermore you will develop and follow a framework of SOP development to ensure the company will maximize the value and benefits.Requirements
- MD or MSc degree in Biomedical Sciences or related area- At least 5 years of relevant work experience in clinical trial management in a pharmaceutical or CRO environment
- Experience with phase I - III in rare diseases
- Excellent verbal and written communication in English, Dutch is a pré
- Working knowledge of ICH/GCP regulations and clinical protocols
- Experience in vendor- and site management
Other information
- Ability to travel up to 10 - 20%- Accommodates a flexible work schedule according to clinical trial(s) priorities
- Perform job duties with minimal supervision and guidance
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Bram Reulen.
Dodatkowe informacje
- Ostatnia aktualizacja
- Wymiar etatu
- Pełny etat
- Rodzaj umowy
- Własna działalność
- Liczba wakatów
- 1
- Min. doświadczenie
- 2 lata
- Min. wykształcenie
- Wyższe licencjackie
- Branża / kategoria
- Praca Medycyna / Służba zdrowia / HealthTech