Senior Specialist, Country Study Start Up

AbbVie; Sydney; On-site; AUD 150,000 - 190,000; Full time

Job summary

AbbVie Australia is seeking a Senior Manager, Country Study Start Up to lead end-to-end start-up activities for clinical studies across Australia. You will own activation plans, manage ethics and regulatory submissions, and coordinate with Regulatory Affairs, Contracts and study teams to keep timelines on track.

You will mentor Country Start Up Specialists, drive process improvements, and promote the adoption of new technologies while ensuring compliance with ICH/GCP guidelines and company

Qualifications

• Bachelor's Degree (health care or scientific field) preferred or equivalent experience.
• Minimum 3 years of clinical research experience; 2+ years in study start up for the designated region.
• Experience with central and local IRB/EC sites and ICF review routing.
• Familiarity with ICH and GCP guidelines and regulatory environments.
• Experience working with remote/virtual teams.
• Strong analytical and communication skills; ability to drive cross-functional initiatives.
• Proven ability to mentor and train junior staff.

Responsibilities

• Lead start-up and maintenance activities for assigned sites/studies to ensure on-time, quality activation.
• Establish activation plans and risk mitigation with cross-functional leads.
• Coordinate ethics/regulatory submissions and local ICF/materials customization.
• Collaborate with Regulatory, CTS, Contracts, and site teams to align activation requirements.
• Track start-up metrics and maintain SSU databases/EDLs.
• Mentor and train Country Start Up Specialists; drive process improvements.

Skills

Analytical thinking

Cross-functional collaboration

Regulatory knowledge

Mentoring / training

Stakeholder management

Remote team experience

Education

Bachelor's Degree in health care or scientific field

Tools

Vault SSU

Job description

Senior Specialist, Country Study Start Up

• Full-time
• Workday Global Grade: 15

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.

Lead study start-up strategy. Accelerate activation. Help bring new medicines to patients sooner.

We’re looking for an experienced Senior Manager, Country Study Start Up to take a leading role in how AbbVie clinical studies move from planning to activation across Australia.

This is an opportunity to step beyond the transactional elements of study start-up and become a trusted country-level expert. You’ll own and drive start-up and maintenance activities across assigned studies and sites, navigating ethics, regulatory and operational requirements while bringing together Clinical Operations, Regulatory Affairs, Contracts and study teams to keep activation on track.

You’ll have the autonomy to establish activation plans, identify and resolve risks, influence cross-functional stakeholders and continuously improve the way we start studies. Just as importantly, you’ll bring your expertise to the broader Study Start Up community, mentoring colleagues, leading process improvements and helping teams adopt new technologies and smarter ways of working.

KEY DUTIES AND RESPONSIBILITIES

• Ensuring successful and on time and quality execution of start-up and maintenance activities for assigned sites and studies; site assignment scope inclusive of central and local IRB/EC sites
• Establishing the country/site activation plans and priorities including risk assessment and mitigation plans with CCOM/COM, Area SSU and CSM Lead, Contract Manager, CTS/Regulatory Affairs
• Proactively identifying and communicating issues impacting delivery and providing proposed solutions.
• Attending regional/area start up calls and providing input for assigned sites/studies
• Collection of essential documents from sites and completing quality check (ALCOA)
• Compiling and submitting ethics and other required local submissions including customization of ICFs, patient facing materials and safety reporting
• Coordinating with Regulatory and CTS on CA submission and approval status to assure alignment with other site activation requirements
• Collaborating with contract manager, CRA, Area CSM Lead as required to assure timely site activation
• Reviewing site and/or IRB/EC comments on ICFs and routing for approval by required functional areas
• Triggering clinical supply shipments
• Completing IP release activities and triggering IP shipment
• Issuing site green light letter and activating sites in IXRS
• Tracking all start up and maintenance related activities in Vault SSU as appropriate
• Maintaining local country and site intelligence database and EDLs in Vault.
• Maintaining SSU performance metrics and KPIs for assigned sites/studies.
• Providing start up updates and metrics to CCOM/COM and Area SSU and CSM Leads
• Ensuring audit/inspection readiness
• Ensuring compliance with corporate and divisional policies and procedures in alignment with worldwide regulations and guidelines
• Drives to improve site start up efficiency, which includes leading process improvement initiatives
• Functions as a SME in the SSU community and leads training and mentoring of Specialists, Country Start Up, drive change management in the adoption of new technologies and processes
• May act as area lead for studies that only involve one country
• 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.

• Bachelor's Degree (degree in health care or scientific field) highly preferred or equivalent years of experience required
• A minimum of 3 years of clinical research experience and preferably 2+ years of study start up management experience for the designated region. Must have hands on experience in interpreting regional clinical research regulations and processes.
• Experience working with central and local IRB/EC sites, inclusive of reviewing site and/or IRB/EC comments on ICFs and routing for approval by required functional areas
• Adept and experienced working with Vault SSU in the capacity of essential document processing, IP release, and ICF IRB/EC review
• Experience working with remote/virtual teams
• Strong analytical and critical thinking skills and the ability to evaluate complex issues from multiple perspectives and drive smart decision making.
• Strong interpersonal skills with the ability to build trust and communicate with clarity, flexibility and adaptability to changing requirements.
• Demonstration of successful start up execution and aptitude for managing multiple priorities in a fast‐paced environment
• Demonstration of driving and leading successful initiatives, special projects and activities that support the business
• Working knowledge of ICH and GCP guidelines and operational understanding of the country's regulatory environment
• Training and mentoring Country Start UpSpecialists in the team

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 [e-mail] 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 applicants seeking a reasonable accommodation