Job Description
CLINICAL TRIAL OPERATIONS SPECIALIST
The following information aims to provide potential candidates with a better understanding of the requirements for this role.
OUR COMPANY
At Boehringer Ingelheim we develop breakthrough therapies and innovative healthcare solutions in areas of unmet medical need for both humans and animals. As a family owned company, we focus on long-term performance. We believe that, if we have talented and ambitious people who are passionate about innovation, there is no limit to what we can achieve; after all, we started with just 28 people. Now, we are powered by 50,000 employees globally who nurture a diverse, collaborative, and inclusive culture.
THE POSITION
We are currently recruiting for a contract Clinical Trial Operations Specialist (CTOS) position to join our UK Clinical Development and Operations (CD&O) team.
As a CTOS, you are responsible for supporting the Clinical Trial Leader (CTL) in coordination around planning, set-up, conduct, closeout and reporting of your assigned trials, according to ICH GCP, BI standard operating procedures and applicable regulatory / ethical guidance.
The CTOS is expected to take initiative and work independently on assigned tasks, but in close collaboration with the CTL and other extended trial team members (e.g. regional Clinical Trial Managers (CTMs)), in addition to external functions (e.g. Clinical Research Organisations, advisors, vendors), to support the seamless and timely delivery of clinical trials.
The CTOS is accountable for supporting the oversight of trial supplies, documentation, submissions, co-ordination of communication, and the management of complex technical systems to manage clinical trials.
TASKS & RESPONSIBILITIES
· Administers and co-ordinates information for the planning, co-ordination and conduct of trial activities in accordance with ICH-GCP and defined timelines, in close communication with, and under the leadership of, the CTL.
· Collaborates and interacts with other core and extended trial team members, country level functions (e.g. CTM) and interface functions (e. g. Clinical Trial Supplies Unit, Sourcing, Legal). Smooth cooperation with external functions (e. g. Clinical Research Organisations, vendors, advisors, investigators) to support the conduct of clinical trials.
· Independently manages the set up and maintenance of technical internal and external systems, tracking tools and reports, under the leadership of the CTL.
· Oversees the preparation, compilation, maintenance and distribution of trial level documents. Performs appropriate quality checks on trial level documents. Ensures timely, complete and compliant archiving in the TMF.
· Keeps overview of records to address local regulatory demands from Ethics / Authorities to support timely submission and resubmissions.
· Coordinates activities related to the preparation of the Clinical Trial Report (CTR)
REQUIREMENTS
· University degree or comparable professional education, or relevant experience in the area of clinical trials.
· Previous experience working in administrative management of clinical trials in an international context and in-depth understanding of corporate culture and cross-culture dynamics.
· Good knowledge of ICH-GCP and understanding of major regulatory requirements (US FDA, EMA and PMDA).
· Strong communication skills.
· Confident user of electronic applications (Word, Excel, Powerpoint).