GLOBAL TRIAL MANAGER, LATE PHASE STUDIES, SINGLE-SPONSOR DEDICATED (HOME-BASED IN EUROPE)

Job Purpose As Senior Global Trial Manager you will contribute to all aspects of the assigned clinical trial(s) to deliver study outcomes within schedule, budget, quality\/compliance and performance standards.
You will lead specific aspects of global clinical trial(s) and will become core member of the Clinical Trial Team (CTT).
Key Responsibilities.
Study essential documents.
\u Development of specific sections of the protocol and related documents; \u Development of study tools, guidelines and training materials; \u Contributing to the development of Case Report Forms (CRFs), edit checks, CRF completion guidelines, data review reports and trial statistical analysis plan in collaboration with the trial data manager, trial statistician, and statistical programmer; \u Contributing to the development of clinical sections of regulatory documents like Investigators' Brochures, safety updates, etc.
Project Management.
\u Ensuring trial information\/results are reported within relevant trial repositories and tracking systems (e.
.
trial results registries); \u Supporting forecast and management of drug supply for Novartis and comparator drug products in collaboration with internal stakeholders; \u Implementing issue resolution plans; \u Ensuring proper handling of all study close out activities including but not limited to site close out, final drug accountability and audit readiness of Trial Master File documentation.
\u Supporting with the development, management and tracking of the trial level life cycle budget including forecast, and annual cost targets.
\u Contributing to defining the Data Review Plan; participate in data review as specified in the Data Review Plan \u Supporting Management of Managed Access Program as assigned.
Support Management of physician request, provide treatment plan guidance, ensure compliance with SAE reporting, and manage drug supply.
Vendor Management.
\u Contributing to development of clinical outsourcing specifications (as required) to facilitate bid process and selection of Contract Research Organizations (CROs); managing interface with CROs in cooperation with outsourcing management and line functions; ensuring vendors meet quality standards; contributing to the development\/amendment of vendor contracts; Internal and external collaboration.
\u Organization and logistics of various trial advisory committees (e.
.
Data Monitoring Committee, Steering Committee); \u Acting as point of contact for all site-related issues and procedural questions; \u Managing interactions with relevant line functions e.
., data management, drug supply management, etc.; \u Participating and reporting study progress and issues\/resolution plan at the CTT meeting; write CTT meeting minutes.
Organizing and chairing trial sub teams.
Ideal Background.
\u Advanced degree or equivalent education\/degree in life science\/healthcare recommended; \u years of experience in managing late phase clinical trials at global level; \u Experience managing Non-Interventional Studies (NIS).
registry studies, phase IV studies, and post-marketing studies.
Post-authorization safety or efficacy studies (PASS or PAES) \u Experience with providing inputs into regulatory and safety documents required for Health Authority submission.
Experience in development of safety update reports (PSUR \/ DSUR), investigator brochure (IB), addendum to clinical overviews (ACO), new drug application annual report (NDA AR), biological license application annual report (BLA); \u Good background of protocol development\/study start up; \u Excellent communication, organization and tracking skills; \u Proven networking skills and ability to share knowledge and experience amongst colleagues; \u Knowledge of Good Clinical Practice; comprehensive knowledge of clinical trial design; understanding of the overall drug development process; \u Enthusiasm and passion for late phase studies.
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