Vacancy for a Clinical Trial Manager
Full time position
The basic responsibility is to execute Glycostem clinical strategy in Immuno-Oncology in a cost effective, safe and regulatory compliant fashion with high Quality Standards.
The Clinical Trial Manager reports directly to the Senior Vice President Clinical Affairs.
- Oversight of clinical trials sponsored by Glycostem and Investigator Initiated Trials supported by Glycostem in close coordination with SVP Clinical;
- Oversight of Contract Research Organisations hired by Glycostem for the conduct of clinical trials;
- Coordination of investigative cell therapy product shipment to clinical sites in close collaboration with Manufacturing, Regulatory Affairs and vendors;
- Co-monitoring of investigational sites to assure research is being carried out in full compliance with relevant requirements;
- Participation in Clinical Investigator and key Scientific meetings;
- Participation in development and review of clinical documentation, relevant Clinical Quality System and conduct of vendor qualification audits;
- Monitoring of clinical trial budget, Trial Master File, timelines and safety issues; and
- reviewing AEs, SAEs, lab data, tables, listings, graphs and reports, IND & EU annual reports, safety update reports, SUSAR reporting etc.
Education, skills and experience
The job as Clinical Trial Manager will be held by a person with:
- At least Bachelor’s degree in nursing or life sciences;
- At least 3+ years work experience as a CTM for pharmaceutical company or CRO. Experience in Oncology in highly desired;
- Outstanding communication skills, both verbal and written in English;
- Proficient with Microsoft Office Word, Powerpoint and Excel;
- Self-starter with ability to work independently and prioritize duties;
- Multitask and pragmatic with ability to keep many projects going at the same time;
- Understanding of Electronic Data Capture (EDC); and Good Clinical Practices (GCP);
- Available to travel for a limited number of Clinical investigator meetings and site co-monitoring with CRO.
Conditions of employment:
- After a successful trial period a permanent contract is extended;
- Competitive salary, after your first year your salary will be adjusted accordingly with your performance and dedication;
- Pension premium contribution;
- Travel allowance or public transport reimbursement;
- 25 holidays; and
- Holiday pay.
Do you have what it takes?
Please convince us by sending your motivation and CV in English to Bianca Eve (Bianca@Glycostem.com).
We reply to you within 3 working days.
Want to know more?
E-mail our HR department at Bianca@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.