Clinical Operations Manager

🔥 1 minute ago

🇦🇺 Australia – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🏥 Clinical Operations

👻 Ghost score 10%

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Logo of AbbVie

AbbVie

10,000+ employees

Founded 2013

🏥 Healthcare

💼 Consulting

🏭 Manufacturing

Healthcare • Consulting • Manufacturing

AbbVie is a global pharmaceutical company that discovers and delivers innovative medicines and solutions to enhance lives. With a focus on addressing the world's toughest health challenges, AbbVie operates in over 175 countries, providing a wide range of products across areas like immunology, oncology, neuroscience, and aesthetics. Committed to scientific innovation, AbbVie invests heavily in research and development, aiming to produce first-in-class medicines. The company also emphasizes workplace diversity, sustainability, and patient support initiatives, ensuring positive impact for both its patients and the broader community.

📋 Description

• Lead and develop a team of clinical research professionals • Manage hiring, retention, performance management, mentoring, task assignment, growth, and development • Provide leadership and oversight to the clinical research team • Perform accompanied on-site and off-site site visits • Accelerate priority clinical programs through collaboration with internal and external stakeholders • Conduct trend analysis and gap assessments to identify training and development opportunities • Address performance gaps and support achievement of country and site KPIs and metrics • Use AbbVie systems and tools to address performance and mitigate risks and issues • Remove obstacles and tailor support for successful, on-time monitoring and study delivery • Support, train, and oversee personnel to maintain audit and inspection readiness • Prepare and follow up on site and country audits, including CAPA preparation and implementation • Manage resources and allocate them in alignment with research goals, priorities, and study timelines • Manage assigned-study budgets and payments, as applicable • Connect business strategy to execution and promote stakeholder collaboration • Drive and implement change through communication and management • Partner with research sites, KOLs, National Leads, Principal Investigators, and site staff • Participate in or lead global and local task forces and initiatives • Identify opportunities and propose solutions to improve processes and efficiencies • Oversee country and site feasibility activities • Support training and monitoring for the team • Develop and implement strategies to support pipeline execution • Collaborate with Medical Affairs and commercial brand teams as appropriate • Ensure adherence to applicable regulations, GCPs, ICH Guidelines, AbbVie SOPs, and quality standards • Report adverse events within 24 hours according to AbbVie policies and procedures • Participate in WHS programs and promote a safe work environment • Complete required training and maintain ethics, integrity, and compliance • Perform other ad hoc administrative duties as requested

🎯 Requirements

• Bachelors or equivalent degree in a health-related field (e.g. Medical, Scientific, Nursing, Pharmacy) • Minimum 5 years of monitoring experience • At least 1 year of direct line management experience preferred • Experience across multiple therapeutic areas and study phases • Advanced interpersonal and cross-functional communication skills • Strong planning and organisational skills • Mentoring and coaching skills • Ability to provide transparent and timely feedback • Ability to drive innovation and continuous process improvement • Ability to make timely, high-quality decisions based on available data • Ability to work independently and take initiative/ownership • Ability to adapt and move quickly • Ability to comply with regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie SOPs, and quality standards • Ability to stay abreast of evolving local regulations, guidelines, and policies • Ability to work flexibly in an international, matrixed environment

🏖️ Benefits

• 12-month max-term contract • Flexible and supportive workplace • Flexible and accessible hiring process • Workplace accommodations for accessibility requirements • Right to Disconnect protections • Support for occasional flexibility outside standard working hours • Inclusive workplace committed to diversity and inclusion

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