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Clinical Operations Manager
vor 3 Monaten
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.
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 researchrelated payments. Oversees financial compliance checks, and maintenance of financial systems.
- 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 35 years' experience in clinical research.
- 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 selfdriven.
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 regional office and manufacturing/packaging facility, Lucerne is considered the center of operations. Approximately 1,000 people work collaboratively at the four Lucerne locations (Tribschenstrasse, Citybay, Schachen and Kriens).
A fifth location has been recently established in Zurich, aimed at accelerating the development and commercialization of many of our company's medicines and vaccines, which supports our mission to save and improve lives around the world.
The new location has a target date of 2021 for operational readiness.We are proud to be certified as a "Top Employer Switzerland" and "Top Employer Europe" showing the company's commitment to our employees and the community around us.
Citybay
The Switzerland Head Office of our company's Swiss Subsidiary is based in Lucerne's city centre. Located in the heart of the cit
