Operational Manager, Research and Operations

This is a fully remote position, open to applicants in Denmark, +1 more country.

📋 Description

• Deliver operational assistance for research studies and medical research initiatives.

• Oversee studies from inception to completion, ensuring alignment with contracts, budgets, timelines, quality standards, SOPs, and regulatory requirements.

• Identify opportunities to leverage real-world data to fill local evidence gaps.

• Assist in evidence generation strategies and provide scientific input for local evidence projects.

• Manage research conducted by affiliates, which includes Investigator-Initiated Studies, non-interventional studies, collaborative research, research projects, and dataset acquisitions.

• Oversee assigned projects from planning through to completion, encompassing documentation, monitoring, budget oversight, and system updates.

• Aid in contract negotiations, invoice processing, vendor selection, and drug deliveries as necessary.

• Offer guidance on the scientific publication process and related publication strategies.

• Provide operational, scientific, and clinical research expertise and advice.

• Ensure compliance with relevant laws, regulations, guidelines, codes of conduct, and AbbVie policies and procedures.

• Contribute to process improvements, innovative working methods, and effective communication and collaboration within the Scandinavian affiliate and with external partners.

• Collaborate closely with Study Leads, Medical Affairs, brand teams, affiliate researchers, healthcare professionals, vendors, and external collaborators.

• Report directly to the Head of Affiliate Research, Scandinavia.

⛳️ Requirements

• A scientific background with a relevant degree or equivalent experience.

• Proven experience with scientific publications, drug development, clinical research, and registry studies.

• At least three years of experience in a comparable role, such as a medical advisor, in market access closely working with research, as a Senior CRA, or as a Startup Specialist.

• Up-to-date and comprehensive knowledge of regulations governing clinical research.

• Strong understanding of ICH/GCP guidelines and other relevant clinical research regulations.

• Proficiency in one Scandinavian language and English, both written and spoken.

• Capacity to collaborate effectively across functions and establish strong relationships with both internal and external stakeholders.

• Proven leadership ability in cross-functional environments.

• Clear, confident, and effective communication abilities.

• Excellent planning, prioritization, and organizational skills.

• Ability to handle multiple projects, deadlines, and stakeholders while maintaining attention to detail.

• Experience in leading processes and applying change management skills to facilitate new working methods.

• Adaptable mindset, capable of managing ambiguity, thinking creatively, and formulating practical solutions.

• Strong sense of responsibility and the ability to work independently while contributing positively to a team environment.

🏝️ Benefits

• Full-time employment.

• Option for remote work.

• Commitment to equal opportunity employment.

• Accommodation support for US & Puerto Rico applicants requesting reasonable accommodations.