InflaRx is a NASDAQ listed biotechnology company with offices in Jena and Munich, Germany. We research and develop new medicines for the treatment of inflammatory diseases within a global development approach. We stand out for an excellent team of highly motivated and skilled individuals who put strong emphasis on a team effort.
To support our expanding CRD team we are looking for a
Senior Clinical Trial Manager (m/f/d) * (up to 6)
(Reference number: 2020118)
We are seeking a highly motivated individual to join the Clinical Operations group. The Senior Clinical Trial Manager leads the cross-functional study execution team, is accountable for managing the full scope of clinical trial(s), coordinates vendor efforts and ensures the clinical trials are initiated efficiently and completed on time, within budget and in compliance with SOPs, regulations, and ICH/GCP guidelines in accordance with the Clinical Development Plan (CDP).
The position is located in Jena or Munich.
The Senior Clinical Trial Manager reports to the Head Clinical Operations.
Overall responsible for successful operational planning and conduct of clinical trials
Lead cross-functional teams and supervise vendors to ensure clinical trials are successfully executed
Provide operational expertise to meet scientific objectives of the clinical studies
Identification and selection of study CROs and vendors, including negotiation of scope of work and budgets
Oversight and management of CROs to ensure delivery against scope of work
Plan and execute investigator meetings and train vendors/ internal staff on study protocol and processes
Ensure that clinical data from a variety of sources is appropriately captured and of high quality
Support the review of study data and assessment of the impact of the data to the clinical development program
Proactively identify and mitigate study-specific risks; effectively communicate study status, changes and risks that may impact quality and timelines to internal and external stakeholders
Manage study budget, identify and communicate variances
Support preparation for audits and regulatory inspections
Advanced scientific degree (MS/MSc/PhD) in life sciences/related discipline or equivalent experience/education
3-5 years of experience in clinical development in biotech, pharma or CRO industry
Experience in planning and managing global clinical trials (ph3 trial experience are of advantage)
Ability to manage cross functional clinical study teams
Experience in CRO oversight
Very good communication and project management skills
Agility and flexibility
Strong working knowledge of FDA, EMA & ICH/GCP regulations and guidelines
Highly effective verbal and written communication and presentation skills in English
An open-ended employment contract with 30 days leave per year
Attractive remuneration and above-average employer participation in the company pension scheme
You design your workplace by bringing in your own ideas and visions
You work in an ambitious company with a highly motivated team
We offer you a challenging and varied opportunity with an innovative, dynamic and expanding company. InflaRx strives to be a company that is recognized by its employees as best place to work for in the industry. We want to accomplish this by working with passion and professionalism on thru medical innovation. We pride ourselves in maintaining a friendly, honest and trusting relationship with each other.
If you are interested in this position, please contact: