| || Accountable for all aspects of the management and clinical execution of early phase clinical trials within Translational Medicine (TM). The Clinical Scientist (CS) leads the planning and implementation of all operational aspects of TM clinical trials from study concept to reporting according to timelines, budget, operational and quality standards (ICH/GCP/Novartis SOPs and procedures). Will also act as a Clinical Project Manager for outsourced profiling studies.
1.Clinical Scientist for Phase I/II studies including multi-country / multi-center trials.
2.Clinical Project Manager for outsourced profiling studies responsibilities include:
• Act as the internal point of contact for vendor(s) conducting outsourced studies
• Oversee outsourced activities, involving key stakeholders to ensure integration and alignment with study objectives
• Measure the effectiveness of the vendors in meeting timelines and deliverables and ensure alignment of vendor activities to priorities and strategy
• Eliminate duplication of efforts between vendor and internal team
• Improve working relationship with vendors (e.g. communication, collaboration, issue resolution) and drive continuous improvements to the outsource model.
3.Responsible for leading and matrix managing the multidisciplinary Clinical Trial Team (CTT) to ensure all trial deliverables are met. Chair CTT meetings, manage team actions, and actively track study progress to ensure completion according to specified timelines, budget and quality standards. Communicate study progress to CTT, CS&I Management, TA Heads and project team members.
4.Lead all aspects of study planning and in collaboration with outsourcing/feasibility personnel, CTT members, local country office representatives and CRAs. Identify sites and manage study set-up, including responsibility for organizing and chairing investigator meetings, or site initiation meetings.
5.Interact with investigator sites and CRAs/CROs/vendors to ensure smooth study set up and smooth study conduct, reviewing site performance, protocol deviations and maintaining awareness of issues raised.
6.Author of the Clinical Study Protocol, amendments and related documents, Informed Consent Form, Study Operations Manual, monitoring plan, and other study essential documents. Train and support CRAs/CROs on study protocol and related questions and serve as point of contact for managing/answering questions relating to trial procedures and subjects’ eligibility.
7. In collaboration with the Medical Expert and CTT, manage the ongoing medical/ scientific review of the clinical trial data, and coordinate the data analysis and interpretation for first interpretable results. Oversee the data review and interactions with the Data Manager, Statistician, and third parties to ensure high quality data are transferred/available in a timely manner.
8.Responsible for the Clinical Study Report writing and publication of studies, either directly contributing to and managing the report writing, or by liaising with the medical writing/narrative group to ensure report is completed according to current requirements.
9.Responsible for the set up and maintenance of the Trial Master File (TMF) for studies, ensuring all relevant study documents are filed and archived at the end of the study according to the appropriate guidelines.
10.Contribute to the evaluation of clinical sites and external service providers performing TM studies in healthy volunteers.
11.Responsible for the coordination of pre-audit activities for nominated projects ensuring a satisfactory outcome is achieved, and address corrective actions.
12.Oversee the work of assigned support Clinical Trial Associates(s), ensuring clear delegation /assignment of duties are documented.
13.Act as a mentor to support the training and on-boarding of new CS&I associates.
14.Provide advice to other departments and line functions and to cross-functional working groups as required. Function as a Subject Matter Expert as assigned.
15.Identify areas for process or technology improvements.
16.Responsible for following best practices and standards for trial management within TM; expected to share lessons learned.
17.Maintain knowledge of ICH-GCP, external regulations and procedures, and supplement by training and practice of Novartis SOPs and internal policies. Assist or perform training for CTA and Clinical Scientists.
| || Education:
MD or PhD with life sciences background preferred, otherwise Bachelor or Master degree in life sciences, nursing or equivalent.
Business-level oral and written English, Fluent in Chinese
1.Approximately 3-6 years experience in clinical trials / drug development.
2.Good knowledge of Good Clinical Practice.
3.Track record of successfully managing multiple Phase I to III clinical trials concurrently.
4.Office and clinical trial software IT computer literacy.
5.Operational project management experience including excellent planning, prioritization, problem solving and organizational skills. Used to managing multiple priorities.
6.Clear written and verbal expression of ideas, an active/proactive communicator.
7.Well-developed interpersonal skills, with a proven track record of successfully interacting with and influencing with a wide range of people, building strong positive relationships.
8.Customer orientation awareness and focus.
9.Used to working independently and in a team environment, being flexible and adapting in a changing environment.