| || Job Purpose:
Accountable for all aspects of the management and clinical execution of early phase clinical trials within Translational Medicine (TM). In conjunction with Novartis, this role 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).
Clinical Scientist for Phase I/II including multi-country / multi-center trials. The main focus will be on high complexity studies leading to clinical Proof-of-Concept or NDA registration.
• Responsible for matrix managing the multidisciplinary Clinical Trial Team (CTT) and support functions to ensure all trial deliverables are met. Actively track study progress to ensure completion according to specified timelines, budget and quality standards. Communicate study progress to Novartis Clinical Trial Team, CS&I Management, TA Heads and Project team members.
• In conjunction with Novartis study head, 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.
• 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.
• Author 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.
• May support the Medical Expert on project documentation e.g. briefing books, IBs, Annual Safety Reports, responses to Health Authority questions, etc.
• Lead the ongoing medical /scientific review of the clinical trial data (in collaboration with the Medical Expert and CTT), coordinate the data analysis and interpretation of first interpretable results, publications and internal/external presentations. Direct 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.
• Accountable for 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.
• Accountable 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.
• Contribute to the evaluation of clinical sites and external service providers for performing TM studies in healthy volunteers and patients.
• Responsible for the coordination of pre-audit activities for nominated projects ensuring a satisfactory outcome is achieved, and address corrective actions.
• Provide expert advice to other departments and line functions and to cross-functional working groups as required. Function as a Subject Matter Expert as assigned.
• Identify and help implement areas for process improvements.
About the Novartis Global Service Center in Prague:
The Novartis Global Service Center (NGSC) in Prague delivers a broad variety of services to the Novartis divisions worldwide. Prague is part of a globalized network of five NGSCs, which form a successful network of services minded associates partnering with the Novartis business around the world.
Are you interested in joining an international team delivering solutions for an ever increasing demand in the healthcare industry? You will have the opportunity to join projects with a global scope and meet colleagues from all over the world. English is our working language. We are looking for candidates combining professional expertise and excellent interpersonal skills to interact with our colleagues in different cultures, countries and time zones.
Our mission is to care and cure; We want to discover, develop and successfully market innovative products to prevent and cure diseases, to ease suffering and to enhance the quality of life. We also want to provide a shareholder return that reflects outstanding performance and to adequately reward those who invest their money, their time and their ideas in our company.
Benefits of Working for Novartis:
Strong work/life balance, flexible working hours
Pension/risk life insurance scheme
5 weeks paid holiday
Cafeteria employee benefit program
Public transportation allowance
Plus additional benefits
‘I came for the job, I stay for the culture’
| || The ideal candidate will have:
PhD level scientist with life sciences background; PharmD; BSc or MSc in life sciences.
Business-level written and oral English
• At least 6+ years experience in clinical trials / drug development.
• Extensive knowledge of Good Clinical Practice.
• Track record of successfully managing multiple concurrent phase I and IIa, complex clinical trials.
• Office and clinical trial software IT computer literacy.
• Demonstrated leadership and problem-solving skills.
• Strong operational project management experience including excellent planning, prioritization, problem solving and organizational skills. Used to managing multiple priorities.
• Clear written and verbal expression of ideas, an active/proactive communicator.
• 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.
• High level of customer orientation awareness and focus
• Used to working independently and in a team environment, being flexible and adapting in a changing environment.
Novartis are an equal opportunities employer and welcome applications from all suitably qualified persons.