Country Study Start Up Specialist

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.   Turn study plans into active clinical trial sites, and help bring new medicines closer to patients. We’re looking for a proactive Country Study Start Up Specialist to take ownership of the critical activities that move clinical studies from planning through to site activation in Australia. Working across studies and sites, you’ll be at the centre of the start-up process, coordinating ethics submissions, essential documentation, informed consent materials and site activation requirements while partnering with Clinical Operations, Regulatory Affairs, Contracts, CRAs and regional and global Study Start Up teams. You’ll anticipate roadblocks, bring the right people together and help keep studies progressing on time and to a high standard. This is an opportunity for someone with clinical research, study start-up, site activation or regulatory submissions experience who enjoys solving problems, managing competing priorities and seeing their work translate into sites becoming ready to enrol patients.   KEY DUTIES AND RESPONSIBILITIES - Ensure successful and on time and quality execution of start-up and maintenance activities for assigned sites and studies; site assignment scope primarily central IRB/EC sites. Establish 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 identify and communicate issues impacting delivery and providing proposed solutions - Attend regional/area start up calls and providing input for assigned sites/studies. Collection of essential documents from sites and completing quality check (ALCOA). - Compile and submit ethics and other required local submissions including customization of ICFs, patient facing materials and safety reporting. Coordinate with Regulatory and CTS on CA submission and approval status to assure alignment with other site activation requirements. - Collaborate 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. Trigger clinical supply shipments. - Complete IP release activities and triggering IP shipment. - Issue site green light letter and activating sites in IXRS. Track all start up and maintenance related activities in Vault SSU as appropriate. Maintain local country and site intelligence database and EDLs in Vault. - Maintain SSU performance metrics and KPIs for assigned sites/studies. Provide start up updates and metrics to CCOM/COM and Area SSU and CSM Leads. Ensure audit/inspection readiness. - Ensure compliance with corporate and divisional policies and procedures in alignment with worldwide regulations and guidelines. -  Participate in process improvement initiatives as required. - 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 1-2 years of clinical research experience and preferably 1+ years of study start up management experience for the designated region. - Experience working with remote/virtual teams - Strong analytical and critical thinking skills and the ability to evaluate complex issues from multiple perspectives. - Strong interpersonal skills with the ability to build trust and communicate with clarity, flexibility and adaptability to changing requirements. - Demonstration of successful execution, preferably in start up, and aptitude for managing multiple priorities in a fast‐paced environment. - Working knowledge of ICH and GCP guidelines and operational understanding of the country's regulatory environmentFlexibility 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. 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