Senior Clinical Operations Manager

Company Description

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

At AbbVie, we don't just deliver medicines. We advance science that transforms patient outcomes.

We're seeking an accomplished Senior Clinical Operations Manager to join our Clinical Operations team in Sydney and play a critical leadership role in the successful delivery of innovative clinical research programs across Australia and New Zealand. This is an opportunity provide strategic and operational leadership across clinical studies in ANZ and to influence the future of clinical development while leading high-performing teams, collaborating with global stakeholders, and helping bring breakthrough therapies to patients faster.

This role is ideal for an experienced Clinical Operations professional who combines scientific credibility with strong people leadership and business acumen. If you're ready to make a broader impact, we'd love to hear from you.

KEY DUTIES AND RESPONSIBILITIES

• Responsible for the hiring, retention, performance management, mentoring, task assignment, growth, and development of their clinical research team.
• Provide leadership and oversight to the clinical research team including, but not limited to:
  • performs accompanied site visits (on-site and off-site)
  • accelerates AbbVie's priority programs through close collaboration with internal and external stakeholders
  • conducts trend analysis and gap assessments to proactively identify training and developmental opportunities for assigned personnel and broader team
  • addresses gaps effectively to help assigned personnel achieve country and site level KPIs and metrics. Utilises AbbVie systems and tools to proactively address performance and mitigate risks and issues
• Proactively identifies individual needs of their team members, removes obstacles, proposes solutions, and tailors support to enable successful, on-time monitoring and / or delivery of their assigned study activities of their assigned studies.
• Supports, trains and oversees assigned personnel to ensure that they maintain audit and inspection readiness at assigned sites/studies.
• Prepare and follow up on site and country audits, CAPA preparation and implementation.
• Accountable for resource management for assigned team and may be responsible for resource management of entire countries. Provide ongoing assessment and input towards resource needs and in allocating resources in alignment with AbbVie's research goals, priorities, and specific study timelines. Proactively identify and communicate issues impacting resource allocation and provides solutions.
• Accountable for the budget management and payments for assigned studies, as applicable
• Leads and supports the team to understand the business strategy and vision.  Supports team to connect strategy to execution and promote collaboration with stakeholders to effectively deliver pipeline.
• Drives and implements change through effective communication and management
• Creates an inclusive environment to enable team members to reach their full potential. Helps team connect strategy to execution and promotes collaboration with stakeholders to effectively deliver pipeline.
• Partners with research sites with high levels of coordinated and impactful site engagement with KOLs, National Leads, Principal Investigators and site staff positioning AbbVie as the partner of choice in clinical trials.
• May participate and/or lead global/local task forces and initiatives.  Responsible for activities as assigned by Country Clinical Operations Manager (CCOM). Proactively identifies opportunities at local/global levels and proposes solutions to create efficiencies and streamline/improve processes.
• Oversight and delivery of country and site feasibility activities in alignment with local and global strategy and expanding AbbVie’s footprint within the country.
• Supporting CCOM may be responsible for functional budget planning and oversight of expenses across country/ies.
• Supporting CCOM in driving insightful and impactful interactions with key external stakeholders and agencies.
• May be assigned on or multiple TA responsibilities within country/ies.  Support training and monitoring for the team.  Develop and implement strategies to support pipeline execution.   Collaborate with local and global cross functional partners including Medical Affairs or commercial brand teams as appropriate.
• Ensures adherence to applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and quality standards in conducting clinical research.
• Stay abreast of new and/or evolving local regulations, guidelines and policies.
• Report any adverse event within 24 hours as per AbbVie’s policies and procedures.
• Proactively participate in AbbVie’s WHS programs, adhere to policies and promote a safe work environment at all times.
• Adhere to AbbVie’s codes of conduct and compliance processes, including timely training and maintaining ethics and integrity.
• Other ad hoc duties such as administrative duties, as requested.

Qualifications

• Bachelors or equivalent degree, health related (e.g. Medical, Scientific, Nursing, Pharmacy).
• Minimum 5 years monitoring experience plus at least 1 year of direct line management experience.
• Advanced interpersonal skills with the ability to communicate persuasively with clarity, collaboratively, and cross functionally.
• Demonstrates flexibility to changing requirements with the ability to establish and leverage relationships and trusted partnerships.
• Demonstrated proactive and positive team player.
• Creates an inclusive environment to enable team members to reach their full potential. Helps team connect strategy to execution and promotes collaboration with stakeholders to effectively deliver pipeline.
• Exhibits strong planning and organizational skills.
• Experience across multiple therapeutic areas and study phases
• Excellent mentoring and coaching skills. Has the ability to provide transparent and timely feedback to raise the bar on individual and team performance.
• Drives innovation and continuous process improvement.
• Acts with integrity in accordance with AbbVie code of business conduct and leadership values.
• Deals comfortably with risk and ambiguity, changing courses when needed.
• Able to make timely, high-quality decisions based on available data and information.
• Ability to work independently, adapt and move quickly, and take initiative/ownership.

Flexibility and Availability: In line with Australia’s 'Right to Disconnect' legislation, we recognise and respect employees' right to refuse contact outside of their working hours, unless such refusal is deemed unreasonable. As we operate in an international, matrixed environment, there may be occasions where your role requires participation in business meetings outside of standard hours. We value and support flexibility and appreciate your willingness to occasionally accommodate these requests to ensure effective collaboration and communication within our global team.

Additional Information

AbbVie is an equal opportunity employer, and dedicated to fostering an inclusive, flexible, and supportive workplace that values and respects every individual. We are committed to operating with integrity, driving innovation, transforming lives, and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability. We ensure a fair and inclusive recruitment process without discrimination against any employee or applicant because of, and not limited to, race, religion, age, physical or mental disability, gender identity or expression, sexual orientation, or marital status. Our hiring process is flexible and accessible, so if you have any specific requests or accessibility requirement, please feel comfortable to let our team know by emailing [email protected] or speaking with your Recruiter and we'll make any necessary adjustments to accommodate your needs.

WAYS WE WORK
All For One Abbvie; We weigh all decisions against the common good. We inspire, share and create as a team. We solve problems for all rather than serving our immediate team.

• Decide Smart & Sure; We make intelligent decisions to create the best outcomes. We act quickly, embrace experimentation, and learn what doesn’t work and get on to what does.
• Agile & Accountable; We streamline and eliminate unnecessary obstacles. We plan but adapt as we go. We delegate and make tough decisions to ensure focus on results, staying keenly aware of the urgency in all we do.
• Clear & Courageous; Open, honest, candid dialogue is core to our work and how we act with each other. We share information freely and continuously to find solutions. We admit mistakes. We grow stronger by putting the courage of our conviction to the test.
• Make Possibilities Real; We question with endless curiosity. We’re never satisfied with good enough—patients depend on us to deliver more. We challenge ourselves to find creative, constructive solutions to turn possibilities into reality.
   

CODE OF CONDUCT & BUSINESS INTEGRITY STATEMENT
AbbVie is committed to observing high integrity and ethical standards in all its business dealings with our customers, with each other, business partners and suppliers.

• AbbVie as a responsible corporate citizen will adhere to these standards, as well as to local, national and international laws.
• All AbbVie employees are responsible for maintaining the Company’s reputation for conduct in accordance with the highest level of business integrity, ethics and compliance with the law.
• Soliciting and/or accepting/attempting/offering bribes or any illegal gratification is therefore cause for immediate dismissal.
• AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled. 

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html