Resumen
Novartis is unable to offer relocation support for this role: please only apply if thislocation is accessible for you.
About the Role
Key Responsibilities:
- Collaborate with colleagues and Line Functions to set realistic project and study timelines, escalating if necessary.
- Lead and manage a cross-functional Clinical Trial Team to ensure effective planning, re-evaluation, and implementation of clinical studies, adhering to timelines, budget, quality standards, and procedures.
- Organize and manage investigators' meetings and internal meetings related to clinical study execution.
- Interact with investigator sites and CRAs/CROs/vendors to ensure smooth study setup and conduct, resolving issues timely in alignment with regulatory requirements.
- Support the preparation of study regulatory documents for submissions and assist with monitoring activities and communications as needed.
- Review site visit reports and monitor activities to ensure quality control.
- Collaborate with data review teams to ensure timely and high-quality data transfer and review.
- Coordinate data analysis and interpretation for initial study results with relevant team members.
- Contribute to the development and approval of study protocols, treatment plans etc.
Key Requirements:
- Life Science degree or equivalent of education, training and experience
- Fluent English (oral and written)
- 10+ years of Clinical Operations experience with strong managerial experience in planning, executing, reporting and publishing clinical studies (interventional and non-interventional, early to late phase) in a pharmaceutical
- Proven ability to work independently, to lead a multidisciplinary cross-functional team in a complex matrix environment (including remote).
- Solid leadership, and project management skills.
- Thorough knowledge of Good Clinical Practice, clinical study design, statistics, regulatory processes, and global clinical development process.
- Demonstrated presentation and diplomacy skills. Advanced negotiation and conflict resolution skills.
- Strong customer-oriented mindset.
- Ability to resolve issues with minimal
You’ll receive:
Monthly pension contribution matching your individual contribution up to 3% of your gross monthly base salary; Risk Life Insurance (full cost covered by Novartis); 5-week holiday per year; (1 week above the Labour Law requirement) ; 4 paid sick days within one calendar year in case of absence due to sickness without a medical sickness report; Cafeteria employee benefit program – choice of benefits from Benefit Plus Cafeteria in the amount of 17,500 CZK per year; Meal vouchers in amount of 105 CZK for each working day (full tax covered by company); Public Transportation Allowance; MultiSport Card, Employee Share Purchase Plan.
Accessibility and accommodation: Novartis is committed to working with and providing reasonable accommodation to all individuals. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in any order to receive more detailed information about essential functions of a position, please send an e-mail to inclusion.switzerland@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
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Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
Accessibility and accommodation
Novartis is committed to working with and providing reasonable accommodation to all individuals. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to receive more detailed information about the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
