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.