9 mrt 2026
Clinical Study Manager (TEMP)
| Branche | Zie onder |
| Dienstverband | Zie onder |
| Uren | Zie onder |
| Locatie | Utrecht |
| Opleidingsniveau | HBO / bachelor |
| Contactpersoon |
Olawale Olukunga +31622258890 |
Informatie
- Establishing a smooth and efficient collaboration within the multi-disciplinary project team, consisting of Clinical Study Researchers, Clinical Study Assistants (CSA’s), Data Management, Supplies, Quality and Science;
- Ensure highly complex studies are set up and conducted in line with GCP and applicable Regulatory requirements;
- Arrange for regulatory and ethics submissions and approvals;
- Select, collaborate with and monitor activities of clinical partners (CRO’s/ sites);
- Provide progress reporting (resources, budgets, timelines);
- Bringing new insights to the company with a pioneering mindset.
Omschrijving
- Establishing a smooth and efficient collaboration within the multi-disciplinary project team, consisting of Clinical Study Researchers, Clinical Study Assistants (CSA’s), Data Management, Supplies, Quality and Science;
- Ensure highly complex studies are set up and conducted in line with GCP and applicable Regulatory requirements;
- Arrange for regulatory and ethics submissions and approvals;
- Select, collaborate with and monitor activities of clinical partners (CRO’s/ sites);
- Provide progress reporting (resources, budgets, timelines);
- Bringing new insights to the company with a pioneering mindset.
Functie eisen
Requirements:- A Master and/or PhD in life science or related scientific discipline;
- Extensive experience in (international) clinical research;
- Thorough knowledge of legislation and ICH-GCP guidelines;
- Ability to solve complex challenges with unique agile approaches;
- Strong project management and passionate leadership skills;
- Excellent communication skills in English and solid influencing skills to interact with internal and external stakeholders;
- Problem solving and critical thinking capabilities.
