Senior Central Monitor

The Senior Central Monitor is at the heart of AbbVies end-to-end Risk Based Quality Management model. This critical role oversees centralised monitoring activities for clinical trials ensuring data quality and patient safety across multiple studies. The role analyses site performance metrics detects risk signals and collaborates with cross-functional teams to proactively address potential issues.

This position requires strong expertise in clinical data review central statistical monitoring tools and risk-based monitoring strategies. You will provide guidance to junior monitors coordinate escalations and contribute to continuous process improvement initiatives. The Senior Central Monitor acts as a key contact for study teams and external partners ensuring compliance with regulatory requirements company SOPs and industry best practices. This is a highly collaborative and analytical role ideal for those passionate about clinical trial quality and operational excellence.

KEY DUTIES AND RESPONSIBILITIES

• Review protocol and ensure Integrated Data Review Plan is updated for the central monitor role within the study ensuring key critical data is included in the plan aligned to role of central monitor.
• Inspect near-real-time aggregate clinical and operational data from multiple sources (eCRF vendor data digital health/wearables etc.). Utilize data analytics and visualizations to uncover insights and see complex patterns within data.
• Use Key Risk Indicators (KRIs) and Quality Tolerance Limits (QTLs) to identify significant issues and emerging risks at the study site program country.
• Clearly document the detected issue / emerging risk.
• Translate the issue / emerging riskthe situation the significance / implication of the data insight and what further action is requiredbreaking down complex concepts into simple language.
• Communicate findings as per planned process to ensure that all cross-functional stakeholders including senior leaders have the same understanding of the issue / emerging risk so that the appropriate follow-up action can be taken.
• Arm the primary site monitor with important information that will enable AbbVie to be the clinical partner of choice; allowing monitors to work differently with site staff and have more productive discussions with our Investigator partners.
• Work collaboratively in the pursuit of quality with the primary site monitor the Study
• Team cross-functional departments and senior leaders.
• Participate in Health of Study and Risk Management Meetings.
• Coach and mentor junior and peer Central Monitor as well as advise their managers on actual challenges theyre facing.
• Assigned to challenging spaces such as Enterprise Critical programs (where the criticality of delivery requires proactive planning for execution on deliverables seamless responsiveness to work volume increases complex therapeutic areas (where enhanced skill building and unique study types etc.
• Contribute to the ongoing development / advancement / improvement of the RBM systemsproviding requirements that will further enable data analysis (i.e. what to look for how to best present the data so that you can see what youre looking forward) and testing the system at the study level to ensure system quality.
• Be an RBQM champion across AbbVie supporting the execution of RBM processes as part of cross-functional teams spanning the R&D portfolio (all therapeutic areas and phases of development).
• Report any adverse event within 24 hours as per AbbVies policies and procedures.
• Proactively participate in AbbVies WHS programs adhere to policies and promote a safe work environment at all times.
• Adhere to AbbVies internal codes of conduct and compliance processes.
• Other ad hoc duties such as administrative duties as requested.

Qualifications :

• Bachelors degree in related field may include life sciences risk-based discipline
• Minimum of 5 years of clinically related or data trend analysis experience; at least 4 years of clinical research monitoring.
• Experience working in an RBQM-model or similar experience with risk-based environment required
• Demonstrated current in-depth knowledge and understanding/or willingness to learn of appropriate therapeutic indications regulations and ICH/GCP guidelines as they relate to the conduct of clinical trials (study management data management and regulatory operations).
• TA experience preferred in one of the following areas (Neuroscience Oncology Immunology Eye Care Medical Aesthetics Womens Healthcare GI).
• Advanced ability to evaluate large volumes of data from multiple sources and complex issues from multiple perspectives to identify and investigate atypical patterns/trends to conduct root cause analysis and to effectively raise issues to ALL-FOR-ONE-ABBVIE stakeholders for appropriate corrective action.
• Advanced ability to anticipate and address critical issues and develop contingency plans proactively.
• Ability to learn and adapt quickly when facing new problems.
• Strong English language skillsspoken written and conversational. 
• Excellent interpersonal skills with the ability to communicate to inform influence convince and persuade with clarity.
• Exhibits strong planning and organisational skills and high level of flexibility in a dynamic environment with competing projects and deadlines.
• Ability to work independently understand and follow work processes.
• Passionate about leveraging power of technology and data analytics to drive better high quality results for AbbVie investigators and patients.
• Competent with Microsoft Office applications (Outlook Word Excel PowerPoint and Teams

Flexibility and Availability: In line with Australias 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 :

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 doesnt 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. Were never satisfied with good enoughpatients 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 Companys 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. 

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Work :

Yes

Employment Type :

Full-time