We are searching for candidates who have an understanding of the various aspects of clinical operations, preferably in oncology or auto-immune/anti-inflammatory trials. We are seeking for a self-motivated, energetic, helpful and detail-oriented professional with an affinity for clinical trial management. Under the supervision of our Clinical Trial Managers, you support the delivery of on-time/on-budget/on-quality project management, while adhering to regulatory guidelines (ICH/GCP). You support the process of selecting CRO’s and vendors for the clinical trials. You are co-responsible for initiation, execution and closure of clinical trials and will be participating in meetings with experts responsible for PK/PD, data management, statistics, medical writing, regulatory affairs, clinical supplies, medical oversight. At an operational level, you keep contact with CROs, vendors and clinical sites for the execution of the trials. You contribute to the development of clinical trial protocols based on the approved clinical trial protocol synopsis together with clinical experts and CRO. You support the production of study documents like PIF/IC, eCRF, monitoring plan and data management plan. You prepare for submissions and approvals by ethics committees and competent authorities together with regulatory affairs staff. You monitor clinical supply availabilities and patient recruitment and make suggestions to optimize these. You contribute to the writing and submitting of relevant trial related reports together with the CRO.
To qualify for this interesting position, you keep an MSc in (bio-)medical, biological, biotechnology sciences or equivalent by experience. You are familiar with supporting auto-immune and/or oncology clinical trials, either on the CRO side or on the sponsor side. You have a minimum of 5 years of experience in clinical operations. You have a demonstrated ability to collaborate with a diverse group of scientific professionals by maintaining good internal and external working relationships. Must be able to work on multiple simultaneous tasks with limited supervision. You have excellent collaboration and communication skills. Finally, you have the ambition and potential to eventually grow into a full CTM responsibility.
A full time position. A set of excellent labour conditions. A permanent position after one year of temporary contract and a positive appraisal. Salary and benefits according to biotech industry standards.
Working at LAVA
With the attractive set of labour conditions LAVA Therapeutics recognizes and rewards its talented and motivated employees. This includes the ability to work together with a group of highly experienced leaders and professionals, who all have a track-record of success in their field of business and in Life Science industry. We offer flexible working hours, a premium-free pension plan, 30 paid vacation days, opportunities for growth and development and a professional working environment, in which hard working is balanced with fun.
Our Core Values
Our company culture is built on five important Core Values: Innovation, Teamwork, Results-orientation, Flexibility and Fun. We understand that innovation is at the heart of what we do. We drive the ability to innovate and we all have a strong awareness about emerging scientific and business opportunities. We work closely as a team, have a constructive and collaborative mindset and we put the common interest of the company above our own individual interest. We have a strong orientation on results, we meet agreed goals in a timely and efficient manner and we deliver on our promises. We are flexible, adapt well to changing circumstances and work well under pressure. Finally, we all contribute to a safe, professional and enjoyable workplace in which people are treated respectfully and diversity is embraced.
How to apply
Please send your CV together with a cover letter to email@example.com referring to the Associate CTM vacancy.
Your application and related information will remain strictly confidential.