1 purpose...to reimagine medicine!
We are hiring an Associate Clinical Trial Leader who will be responsible for supporting all aspects of Translational Clinical Oncology clinical trial(s) as assigned under the guidance of the Lead Clinical Trial Leader and the Clinical Program Leader.
1.Support the clinical protocol development process in collaboration with the CTL/Lead CTL and the Clinical program Leader (CPL): contribute in the development of clinical protocols, amendments and related documents; drive and/or contribute to the development of trial-related documents and processes
2.Contribute, with the support of a CTL/Lead CTL and the CPL, to the development of clinical section of regulatory documents like Investigator's Brochure, safety updates, IND/NDA submission documents, responses to Health Authorities questions.
3.Investigator/site relationship management is vital; support CTL/Lead CTL and CPL in developing effective working relationships with investigators. Support protocol training meetings and support CPOs in regulatory submission preparation and the conduct of regional meetings.
4.Under the guidance of the CTL/Lead CTL, support the global multidisciplinary CTT to ensure all trial deliverables are met according to timelines, budget, quality standards and operational procedures: attend CTT meetings, assist in report study progress and issues.
5.In collaboration with the CPL, 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.
6.Support the CPL/CTL or Lead CTL in preparing dose escalation meetings with investigators. Under the supervision of the CTL/Lead CTL 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.
7.Responsible for accuracy of trial information in all trial databases and tracking systems.
8.Attend relevant meetings to support ongoing execution of clinical trial and program level activities..
9.Under the guidance of a CTL/Lead CTL 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.
Under the guidance of the CTL/Lead CTL develop clinical outsourcing specifications to facilitate bid templates and selection of CROs and other 3rd parties including central lab and imaging vendors; manage interface with external vendors in cooperation 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).
Act as local trial leader (LTL) for all US activities including working closely with US GMO for all study start-up activities including regulatory documents, budget, contract agreements and all activities pertaining to updates as dictated by amendments. As the LTL, be the primary contact for US sites for clinical conduct of the trial.
JD TCO Associate CTL, September 2015
aCTLs based in TCO Shanghai, support local CTA submission including validation of translation of protocols, amendments, ICFs, IBs etc. for TCO trials with sites in China.
Support the implementation of best practices and standards for trial management, including sharing lessons learned.
Support/drive the maintenance of simple studies/studies in closeout phase or ongoing studies post primary database lock with the oversight of the LCTL/CTL, as assigned.