Associate Clinical Trial Leader

Your responsibilities include, but are not limited to:
May lead studies in maintenance or in closeout phase or ongoing studies post primary database lock with the oversight of the LCTL/CTL, as assigned. Support the clinical protocol development process in collaboration with the CTL/Lead CTL and the Clinical program Leader (CPL): chip in to the development of clinical protocols, amendments and related documents; drive and/or supprt trial-related documents and processes.
development of clinical section of regulatory documents like Investigator’s Brochure, safety updates, IND/NDA submission documents, responses to Health Authorities questions.
support the global multidisciplinary CTT to ensure all trial results are met according to timelines, budget, quality standards and operational procedures: attend CTT meetings, assist in report study progress and issues.
support the CTL/Lead CTL, in the ongoing review and cleaning of the clinical trial data, support final analysis and interpretation including the development of clinical trial reports, publications and internal/external presentations.
coordinate the real time availability of quality clinical trial data, including safety, efficacy, pharmacokinetic, imaging and biomarker data, to provide consolidated information for dose escalation meetings with investigators.
Responsible for accuracy of trial information in all trial databases and tracking systems. Attend relevant meetings to support ongoing execution of clinical trial and program level activities.
ensure that program specific standards/activities (e.g., CRFs, UAT testing, database specifications, Data Handling plan, outsourcing specifications including imaging, biomarkers, PK, data monitoring, validation plans and data transfer specifications) are applied to the clinical trial, where applicable.
develop clinical outsourcing specifications to facilitate bid templates and selection of CROs and other 3rd parties including central lab and imaging vendors; handle work with external vendors in collaboration with the CRO; Management Department as well as with the Assay Research Lab. This also includes the set-up, logistics, documentation and clinical supplies needed for the clinical trial(s).