Associate Clinical Scientist
Associate Clinical Scientist
Job DescriptionWe are Clinical Sciences and Innovation at Novartis. A dynamic group of Clinical Scientists who plan and execute early phase trials worldwide. From First-in-Human to Proof-of-Concept and beyond. We design and operationalize trials, ensuring they run smoothly, on time and – most importantly – with patients’ interests to the fore.
Responsible for supporting, under the guidance of the Clinical Scientist, all aspects of the management and clinical execution of early phase clinical trials within Translational Medicine (TM), and program level activities as assigned.
1. Support the global multidisciplinary Clinical Trial Team (CTT) to ensure trial deliver- ables are met according to timelines, budget, quality standards and operational best practices. Undertakes defined responsibilities delegated by the Clinical Scientist (CS), including regional management of study conduct, and/or vendor oversight of study related tasks.
2. Attend CTT meetings, manage team actions, and actively track study progress to en- sure completion according to specified timelines and quality standards.
3. In collaboration with outsourcing/planning/feasibility personnel, CTT members, local country office representatives and CRAs, support the identification sites and manage study set-up, including support for organizing Investigator meetings or Site Initiation meetings.
4. Interact with investigator sites and CRAs/CROs/vendors and support CS to ensure smooth study conduct, reviewing site performance, protocol deviations and main- taining awareness of issues raised.
5. Contribute to the development of the Clinical Study Protocol, amendments and re- lated documents, Informed Consent Form, Study Operations Manual, monitoring plan, and other study essential documents.
6. Support CS in ordering and management of clinical trial materials, including investi- gational medicinal product, CRFs, laboratory kits, and other clinical supplies.
7. Regularly update all trial information databases in order to manage accuracy of in- formation. Including internal CTMS systems and external databases according to Novartis disclosure policies and individual country regulations.
8. In collaboration with the Medical Expert and CTT, support the ongoing medical / sci- entific review of the clinical trial data, and the data analysis. Assist in data review and interactions with the Data Manager, Statistician, and any third parties to ensure high quality data are transferred/available in a timely manner.
9. Support the Clinical Study Report writing; either by 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.
10. Support the set up and maintenance of the Trial Master File (TMF) for studies, en- suring all relevant study documents are filed and archived at the end of the study according to the appropriate guidelines.
Minimum requirementsWhat you will bring to the role:
PhD level scientist with life sciences background; PharmD; BSc or MSc in life sciences.
Business-level oral and written English.
1. Approximately 1-3 years experience in clinical trials / drug development.
2. Knowledge of Good Clinical Practice.
3. Office and clinical trial software IT computer liter- acy.
4. Demonstrated organizational skills.
5. Clear written and verbal expression of ideas, an active/proactive communicator.
6. Good interpersonal skills, ability to successfully interact with and influence with a wide range of people.
7. Customer orientation awareness and focus.
8. Experience of working successfully in a team and managing multiple priorities.
Why consider Novartis?
750 million. That’s how many lives our products touch. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?
We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.
We are Novartis. Join us and help us reimagine medicine.