Job Summary:
Alvotech is seeking a skilled Clinical Operations Manager for a 12-month full-time contract in Stockholm, Sweden. This role offers an exciting opportunity to lead and manage the execution of global clinical development programs, ensuring all trial activities meet the highest regulatory and quality standards. Ideal for professionals with strong clinical trial management expertise, this position plays a vital role in advancing Alvotech's innovative therapeutic solutions.
Key Responsibilities:
Manage assigned clinical trials ensuring adherence to timelines, budget, and ICH-GCP standards.
Oversee Trial Master File (TMF) maintenance, invoice verification, and essential document updates.
Coordinate internal teams and act as the main liaison with CROs, vendors, and trial sites to ensure sponsor oversight.
Report on trial progress and escalate critical issues to Clinical Operations leadership as needed.
Contribute to the development of protocols, regulatory documents, and operational plans.
Support clinical trial forecasting, supply chain management, and process improvement initiatives.
Ensure continuous compliance with global regulatory updates and internal SOPs.
Required Skills & Qualifications:
Master's degree or higher in a relevant scientific discipline (Pharm.D. or Ph.D. preferred but not mandatory).
Proven clinical operations experience in pharmaceutical, biotech, or CRO settings.
Strong expertise in managing clinical trials across multiple regions (Europe, US, Asia-Pacific).
In-depth knowledge of GCP, ICH guidelines, and international regulatory frameworks (EMA/FDA).
Experience in biologics or biosimilars development is an advantage.
Excellent organizational, communication, and teamwork skills.
Ability to lead multifunctional teams and coordinate complex clinical programs.
Fluency in English (written and spoken); additional language skills are beneficial.
Willingness to travel internationally as per trial needs.
Perks & Benefits:
Work on impactful projects that improve global health.
Be part of a growing and innovative biopharmaceutical organization.
International work culture emphasizing collaboration, inclusion, and flexibility.
Support for personal and professional growth through structured development programs.
Positive and dynamic work environment fostering creativity.
Opportunity to work with diverse, high-caliber colleagues.
Access to company-sponsored social events, wellness programs, and career development resources.
Company Description:
Alvotech is a globally recognized biopharmaceutical company dedicated to developing high-quality, affordable biologics. With cutting-edge facilities and a strong pipeline in biosimilars, Alvotech is revolutionizing patient care through scientific excellence and regulatory compliance in the healthcare industry.
Work Mode:
On-site – Stockholm, Sweden
Call to Action:
Ready to drive global clinical trials and shape the future of innovative therapies? Apply now to join Alvotech as a Clinical Operations Manager and make a difference in healthcare worldwide.
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