InflaRx is a biotechnology company with offices in Jena (headquarter) 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 two
Senior Clinical Trial Manager (m/f)
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).
She/he reports to the Head Clinical Operations. The position is located in Jena or Munich.
Lead cross-functional teams and supervise vendors to ensure clinical trials are executed on time
Provide operational expertise to meet scientific objectives of the clinical studies
Partner closely with clinical development functions to design and write clinical trial protocols
Independently draft, review and implement study management plans and vendor oversight plans; ensure CROs and other vendors adhere to study plans
Provide direction and oversight of CROs and vendors to ensure delivery against scope of work; manage vendors by key performance indicators
Lead the identification and selection of study CROs and vendors, including negotiation of scope of work and budgets
Conduct study feasibility assessments; partnering with team and program lead on final country and site selection
Plan and execute investigator meetings and train vendors/ internal staff on study protocol and processes
Work with external partners to ensure that clinical data from a variety of sources is appropriately captured and of high quality
Participate in the ongoing and final 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, risks, and changes that may impact quality, timelines, and cost to internal and external stakeholders
Manage study budget; identify and communicate variances
Participate in and lead department process improvement initiatives and system implementation
Review and provide input on cross functional SOPs, working practices and assist in the creation and improvement of department infrastructure as directed
Support preparation for Regulatory inspections
Advanced scientific degree (MS/MSc/PhD) in life sciences or related discipline
5+ years of experience in clinical development in the biotech, pharma or CRO industry
Experience in immunology or related therapeutic area
Proven ability to successfully plan, implement, and manage global clinical trials
Ability to manage cross functional clinical study teams to high performance
Proven ability to effectively manage and negotiate with CROs and clinical study vendors
Strategic thinking 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
Ability to travel (up to 20%)
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. We look forward to receiving your application by e-mail.