Apply to JobJob ID242351BRPosition TitleClinical ManagerAAA Statement Advanced Accelerator Applications, a Novartis company, is an innovative radiopharmaceutical company developing, producing and commercializing molecular nuclear medicine theragnostics. AAA offers professionals the opportunity to face new challenges and pursue a career in a fast growing, technology driven healthcare company. We are passionate about improving patient health by leading innovation in nuclear medicine. We are looking for people who share our commitment to help us achieve this goal. Advanced Accelerator Applications is an Equal Opportunity Employer (EOE).Job DescriptionPurpose of Job: Plans and manages the assigned clinical trial(s) to deliver study outcomes within schedule, budget, quality/compliance and performance standards. May lead specific aspects of the assigned clinical trials. Member of the Clinical Trial Team, deputy for the Clinical Development Manager / Director. Contributes to operational excellence through process improvement and knowledge sharing across programs and functions.
1. Contributes to all trial deliverables, under the oversight of the Clinical Development MD (CDMD) and the Clincial Development Director, according to timelines, budget, operational procedures, quality/compliance and performance standards with the following responsibilities:
• Development of the protocol and related documents as well as study tools, guidelines and training materials;
• Organization and logistics of various trial advisory committees (e.g. Data Monitoring Committee, Steering Committee);
• Ensuring trial information/results are reported within relevant trial repositories and tracking systems (e.g. trial results registries);
• Supporting forecast and management of drug supply for Novartis and comparator drug products in collaboration with internal stakeholders;
• Contributing to development of clinical outsourcing specifications 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;
• 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;
• Contributing to the creation and execution of an operational risk management plan, highlighting potential risks and actions;
• Implementing issue resolution plans;
• Acting as point of contact for all site-related issues and procedural questions;
• Managing interactions with relevant line functions e.g., data management, drug supply management as well as country organizations
• 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.
2. Contributes to the development, management and tracking of the trial level life cycle budget including forecast, and annual cost targets
3. As member of the global cross-functional Clinical Trial Team contribute to preparation of the data review plan and participate in the data reviews; report study progress and issues/resolution plan, as well as composing meeting minutes. Deputizes for the CDMD to chair and facilitate CTT meetings. Organize and chair trial sub teams within the scope of his/her delegated responsibilities.
4. Support the Medical Review Committee process and as well as in overseeing third-party Investigator Initiated Trials (ITTs), Regional and locally sponsored AAA trials within disease area. Support collaboration with countries to track study progress, update databases and oversee budget
5. Support Managed Access Program as assigned. Collaborate with MAP Governance Board as appropriate. Support Management of physician requests, provide treatment plan guidance, ensure compliance with SAE reporting, and manage drug supplies. Awareness of local regulatory requirements.
6. Contribute to the development of clinical sections of regulatory documents like e.g., Investigators’ Brochures, annual safety update reports.Minimum requirementsAdvanced degree or equivalent education/degree in life science/healthcare recommended
3-5 years of experience in a pharmaceutical company or a contract research organization with a minimum of 2 years in global clinical research. Involvement in cross-functional, multicultural and international clinical trials demonstrated capabilities in supporting operational aspects of clinical trial related activities
• Knowledge of Good Clinical Practice; comprehensive knowledge of clinical trial design; understanding of the overall drug development process.
• Excellent communication, organization and tracking skills. Strong operational skills and demonstrated ability to meet timelines.
• Proven ability to work independently AND in a team setting, to meet goals by managing compliance, budget and timelines.
• Proven networking skills and ability to share knowledge and experience amongst colleagues.
• Basic knowledge of appropriate therapeutic area.
Languages: Fluent English (oral and written)DivisionOncologyBusiness UnitAdvanced Accelerator ApplicationsLocationSwitzerlandSiteGenevaCompany/Legal EntityAdvanced Accelerator Applications Switzerland SAFunctional AreaResearch & DevelopmentJob TypeFull TimeEmployment TypeRegular
