Clinical Operations Associate

vor 3 Monaten

Holzkirchen, Deutschland Sandoz Vollzeit

Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines.

Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and strengthen its culture for us, the Sandoz associates. This is an exciting time in our history, and by creating a new and ambitious path, it will provide a unique opportunity for us all, both professionally and personally.

Join us as a Founder of our ‘new’ Sandoz

**Your Key Responsibilities**:
Your responsibilities include, but not limited to:

- Support/execute assigned operational activities in conduct of clinical trial(s) in close collaboration with Clinical Operations Manager(s) and Clinical Operations Associate Director
- Support preparation and review of clinical trial functional documents
- Track of clinical trial related data/information e.g. timelines, enrollment, HA/EC submissions and approvals, operational issues and actions etc.
- Support/conduct Sponsor oversight activities
- Manage Investigation Product (IP) handling and oversight activities e.g. track IP shipments, return, destruction, temperature deviations etc.
- Organize clinical trial meetings, prepare meeting minutes and follow-up on open actions
- Support Trial Master File set-up, maintenance and close-out (paper or electronic) during the clinical trial and perform regular QC check
- Support timely identification, management and documentation of quality issues/deviations in conjunction with Clinical Quality Assurance (CQA)
- Support audit, Health Authority inspections and pre-inspection activities
- Support process improvement initiatives
- Performs other tasks, as assigned by the manager and tasks based on a specific appointment
- Responsible for continuous personal and professional development (knowledge, skills and behaviors)

What you’ll bring to the role:
Essential Requirements:

- Bachelor’s Degree or equivalent qualification in life science/healthcare,
- Previous experience in clinical operations is preferred
- Basic understanding of ICH / GCP Guidelines and health authority regulations (e.g. US FDA, EMEA)
- Basic knowledge of the drug development process
- Good communication, organization and tracking skills
- Ability to analyse, interpret and present data
- Demonstrated ability to work independently
- Fluent English (oral and written)

**Why Sandoz?**

Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more

With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.

The future is ours to shape

**Commitment to Diversity & Inclusion**:
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Hiring decisions are only based on the qualification for the position, regardless of gender, ethnicity, religion, sexual orientation, age and disability.

**Join our Sandoz Network**:
**#Sandoz**

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