Clinical Operations Manager
vor 16 Stunden
We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.
In this position you are working for a leading biopharmaceutical company with a diversified portfolio of prescription medicines and vaccines. The company has longstanding commitment to prevent and treat diseases and invests significantly in research and development to address unmet public health needs with innovative treatment options. Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you will have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
As an addition to our Global Clinical Trial Operations Team based in Lucerne, we are looking for a **_Clinical Operations Manager (COM)_**.
As a Clinical Operations Manager, you are responsible and accountable for assigned protocols for budget/finance aspects, for execution and oversight of clinical trial submission and approvals in Switzerland and to ensure site ready.
The primary activities include but are not limited to:
- Executes and oversees clinical trial country submissions and approvals for assigned protocols.
- Ownership of country and site budgets. Development, negotiation and completion of Clinical Trial Research Agreements.
- Oversees clinical research-related payments. Payment reconciliation at study close-out. Oversees financial compliance checks, and maintenance of financial systems. Financial forecasting in conjunction with Sr.COM /other roles.
- Develops local language materials including local language Informed Consents and translations. Interacts with IRB/IEC and Regulatory Authority for assigned protocols.
- Oversees import activities for clinical trial supplies into Switzerland and maintains broker relationship.
- Manages country deliverables, timelines and results for assigned protocols to meet country commitments. Responsible for quality and compliance in assigned protocols in country.
- Contributes to the development of local SOPs.
- Coordinates and liaises with CRM, CTC, CRA to ensure country deliverables are obtained for submissions, budgets, contracts and local milestones. Collaborates closely with Headquarter to align country timelines for assigned protocols.
- Oversees and coordinates local processes, clinical and ancillary supplies management, importing and exporting requirements, supplies destruction, local electronic/hard copy filing, archiving and retention requirements, and insurance process management. Enters and updates country information in clinical and finance systems.
- Contribute or lead initiatives and projects adding value to the business.
- Contributes strongly to COM team and other Country Operations roles knowledge by acting as process Subject Matter Expert (SME), sharing best practices, making recommendations for continuous improvement and providing training as appropriate/required.
Qualifications:
- Bachelor’s or Master's Degree in Life Science, Biology or equivalent. Education in business finance or administration would be advantageous.
- Minimum of 3-5 years’ experience in clinical research or clinical research + finance.
- Deep knowledge of the local regulatory environment, as well as scientific and clinical research knowledge is required.
- Excellent German and English communication skills (verbal and written), Italian and/or French would be an asset. Strong communication, leadership, and negotiation as well as excellent influencing and mentoring skills.
- Knowledge in budget and contract negotiation, submission and approval process.
- Strong coordination and organizational skills.
- Ability to make decisions independently with limited oversight from the manger. Proactively develop risk management and mitigations plans and resolve issues locally.
- Effective and efficient time management, organizational and interpersonal skills.
- High sense of accountability and urgency in order to properly prioritize deliverables, ability to focus on multiple deliverables and protocols simultaneously is essential.
- Ability to work effectively in office but also remote/virtual environment with a wide range of people.
- Positive mindset, growth mindset, being self-driven.
Your role is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement.
**THE COMPANY**
Our company has had a presence in Switzerland since 1963. With a region
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