Located at the heart of Frankfurt am Main, Speransa Therapeutics is an innovative and dynamic clinical-stage (Europe and US) biotechnology company developing COVID-19 vaccines.
We are looking for a talented clinical trial manager to join our team and contribute to the development of a new generation of COVID-19 vaccines and corona vaccines. The clinical trial manager will be responsible for coordinating clinical trial activities from development of study documents, site capability and feasibility assessments, site set-up and study conduct to database lock, through data interpretation, analysis, and reporting. The jobholder will ensure a smooth running of clinical trials, and directly report to the VP, Clinical Operations. The clinical trial manager will maintain and generate documentation pertaining to the management of trials and will manage partners and CROs to ensure the above goals are fulfilled.
Responsibilities include, but are not limited to
- Participate in the development of clinical trial documents and manuals, including but not limited to Protocol, Informed Consent Forms, Laboratory Manual, Pharmacy Manual and other regulatory documents such as the Investigators Brochure (IB)
- Ensure studies are carried out according to the study protocol, SOPs, and ICH/GCP regulations and study-specific manuals and procedures
- Select, coordinate, and monitor activities of study vendors
- Manage evaluation and selection of investigational sites
- Review monitoring reports and conduct co-monitoring visits, as needed
- Assist study CRA and third-party vendor training on protocol and practices
- Oversee performance of CROs, third party vendors, and study CRAs to ensure compliance with study protocol and in accordance with scope of work; identifying areas of concern and escalate to the VP, Clinical Operations
- Participate in the development and tracking of trial(s) timelines, budget and priorities
- Track and report on progress of clinical trial including site activation, patient accrual, monitoring visits
- Manage investigational products (IPs) accountability and reconciliation process
- Ensure appropriate clinical trial supplies are provided to investigational sites in due time with the support of CMC / Operation
- Contribute to clinical data review
- Participate in internal sub-team meetings, safety monitoring boards, CRO meetings
- Ensure adherence to Good Clinical Practice and all applicable local and international regulations
- Other responsibilities to be determined depending on the candidate’s willingness to grow, learn and take on responsibility
Important skills
- Be a team player, used to work in a multidisciplinary setting
- Be a strong and flexible all-rounder with excellent communication
- Solution-oriented mindset, willingness to learn and take responsibility
- Proactive and highly motivated, ability to handle several tasks in parallel
- Good planning, prioritization, problem solving and organizational skills
- Strong communication skills, used to be communicative with a broad range of stakeholders and to build strong positive relationships
Qualifications
- Master’s degree in biochemistry, biology, or any other health-related discipline
- At least three years of experience in the conduct and management of clinical trials
- Proficient with MS Office programs
- Fluent (spoken and written) in English and German
What we have to offer
- Modern, flexible workplaces in the heart of the city of Frankfurt
- Direct exposure to senior management with a lot of responsibility
- Start-up-culture (hands-on mentality, opportunity to make an impact, flat hierarchy, fast decision-making, teamplay, varying responsibilities)
- Dynamic work environment with a lot of opportunities to take on new responsibilities
- Opportunity to make a difference by being part of a young, innovative biotech
Please apply on-line (https://www.speransatherapeutics.com/career) or send your complete application (CV, reference letters, diplomas) to careers@speransatherapeutics.com
