Full time position
The basic responsibility is to deliver and execute the Glycostem clinical development strategy for the assigned innovative NK cell therapy projects in a cost effective, safe and regulatory compliant fashion.
The Clinical Trial Manager reports directly to the Medical Director.
- Execution of clinical trial strategies in close coordination with the Medical Director.
- Ensuring projects are conducted in compliance with relevant regulatory requirements and standards, and in accordance with Glycostem standard operating procedures and policies.
- Ensuring projects are conducted according to defined scope, quality, budget and timelines.
- Oversight of clinical trials sponsored by Glycostem and Investigator Initiated Trials supported by Glycostem in close coordination with the Medical Director.
- Oversight of Contract Research Organizations (CROs) and other vendors appointed by Glycostem for the conduct of clinical trials
- Coordination of investigational medicinal product shipment to clinical sites in close collaboration with the Glycostem Manufacturing, Operations and Regulatory Affairs departments and vendors.
- Co-monitoring of investigational sites to assure that clinical research is being carried out in full compliance with relevant requirements.
- Participation in Investigator Meetings and key scientific meetings/conferences.
- Participation in development and review of clinical documentation and relevant clinical Quality Management System and conduct of vendor qualification audits.
- Participation in the interpretation of clinical trial data.
- Maintenance and archiving of the clinical trial documents, including Trial Master Files.
- Cross-functional interactions with Glycostem Manufacturing, Development, Research, Regulatory Affairs and Quality Assurance departments.
- Participation in the writing and review process of medical sections of regulatory documents for EU and US applications; assisting team with preparations for regulatory agency meetings and reports.
Education, skills and experience
The job as Clinical Trial Manager will be held by a person with:
- Bachelor’s degree in life sciences or health-related field.
- 3+ years work experience as a CTM or equivalent for pharmaceutical/biotechnology company or CRO.
- Experience in oncology, immunotherapy and/or cell therapy is highly desired.
- Thorough understanding of ICH-GCP guidelines, regulations and cross-functional clinical processes including data management, electronic data capture systems, biostatistics, medical writing, pharmacovigilance and regulatory affairs.
- Outstanding communication skills, both verbal and written in English.
- Proficient with the Microsoft Office suite, in particular PowerPoint, Word and Excel.
- Ability to work independently and prioritize duties.
- Ability to keep many projects going at the same time.
- Effective time management and organization skills and meticulous attention to detail.
- Demonstrated ability to work within small teams in a fast-paced environment.
- Experience managing CROs and other vendors.
- Problem-solving skills.
- Available to travel for a limited number of clinical investigator meetings and site co-monitoring visits with CRO.
Conditions of employment:
- A permanent contract is offered;
- Competitive salary
- Pension premium contribution;
- Travel allowance or public transport reimbursement;
- 25 holidays; and
- Holiday pay.
Do you have what it takes?
Please apply by sending your cover letter and CV in English to Liana van Genuchten (HR@Glycostem.com). We reply to you within 3 working days.
Want to know more?
E-mail our HR department at HR@Glycostem.com for more information about Glycostem and the selection process.
Recruiters should not contact us.
Please be aware that your application means that the information you provide will be shared by and with HR and the employees who are involved with the procedure. In case the procedure with you ends, your application and provided information will be deleted within four weeks after the moment you have been informed. Your name and date of application will be registered in our database for statistical use and status only. By applying you agree with and have taken notice of these conditions.