Accountable for execution and oversight of local operational clinical trial activities in Australia and New Zealand in compliance with ICH-GCP and country regulations, company policies, procedures and quality standards.

Accountable for execution and oversight of local operational clinical trial activities in Australia and New Zealand for assigned protocols in compliance with ICH GCP, country regulations, policies and procedures and quality standards.

Responsible for regulatory, ethical and the contractual lifecycle of a study, driving study start-up, delivering timely maintenance activities through to close across ANZ.Responsible for the preparation, review and approval of country and site related submission packages in accordance with ICHGCP and all applicable regulations, laws and other guidelines and ethical standards – within specific timelines and quality standards. Responsible for the collation and verification of the… Show more Responsible for regulatory, ethical and the contractual lifecycle of a study, driving study start-up, delivering timely maintenance activities through to close across ANZ.Responsible for the preparation, review and approval of country and site related submission packages in accordance with ICHGCP and all applicable regulations, laws and other guidelines and ethical standards – within specific timelines and quality standards. Responsible for the collation and verification of the submission documentation; accountable for the dispatch and tracking of submissions to CA, ECs and other bodies as appropriate. Responsible for development of country and site specific Informed Consent Documents (ICDs); country budgets according to FMV; negotiation of institutional/pharmacy budgets and contract review and finalisation; preparation, review and approval of site level essential documents for Investigational Product (IP) release in accordance with regulatory / sponsor requirements – within specific timelines and quality standards.Proactively maintain communication with investigational sites.Track and coordinate reporting activities to clinical teams. Lead ICD reviewer and SME for ICD preparation and review process.Mentor for new and junior personnel as required. Show less

Manager of the ANZ Study Start-up team. Responsible for the coordination, management and support of team activities related to study start-up with a focus on quality, efficiency and cost containment. Effectively managing staff through open and timely sharing of information, regular performance review and feedback and setting clear goals and objectives. Involved in local, regional and global opportunities for process improvements and developing and monitoring process change implementation.

Involved in feasibility and site selection activities and mentoring junior staff in the conduct of site selection visits. Responsible for the independent preparation, review and approval of country related submission packages in accordance with ICHGCP and all applicable regulations, laws and other guidelines and ethical standards – within specific timelines and quality standards. Responsible for independent preparation, review and approval of site level critical documents for Investigational… Show more Involved in feasibility and site selection activities and mentoring junior staff in the conduct of site selection visits. Responsible for the independent preparation, review and approval of country related submission packages in accordance with ICHGCP and all applicable regulations, laws and other guidelines and ethical standards – within specific timelines and quality standards. Responsible for independent preparation, review and approval of site level critical documents for Investigational Product (IP) release in accordance with regulatory / sponsor requirements – within specific timelines and quality standards; develop and finalize Master and Country Specific Information Sheets / Informed Consent Forms (SIS/ICFs). Accountable for the collation and verification of the submission documentation in assigned countries; accountable for the dispatch and tracking of submissions to CA, ECs and other bodies as appropriate. Produce and deliver local regulatory, submission and sponsor specific training for assigned country level personnel. Coordinate reporting activities to sponsor and clinical teams. Participated in business development activities and client meetings, as required. Mentor / train new and junior personnel in study start-up. Lead and/or serve as consultant on Investigator Contract and Budget development process from origination through finalization. Review and negotiate Investigator contracts and budgets. Maintain communication with Investigative sites, Sponsors and internal personnel regarding status of contract and contract-related documents. Show less

Responsible for identification, selection, all aspects of study start-up, initiation, and close-out of investigational sites for clinical studies. Site management and monitoring according to the study protocol, SOPs/WPs, applicable regulations and the principles of ICHGCP.Coaching and mentoring of monitoring competence for inexperienced/less experienced colleagues.

Research on the interaction of various compounds with hepatic enzyme systems in particular NADPH-dependent CYP450 and NAD(H)- linked oxidoreductases