• 50% office based
• Hybrid PM role

The Clinical Trial Manager serves as the clinical functional lead, accountable for the clinical monitoring/site management delivery of assigned study(ies). The position as defined by scope provides leadership, mentoring, and technical support to the Clinical Operations team to ensure quality of deliverables and achievement of financial goals.

JOB RESPONSIBILITIES

 Ensures quality of the clinical monitoring and site management deliverables within a project and maintain proper visibility of its progress by the use of approved systems and / or tracking tools. May include the development of the Clinical Management Plan (CMP)/Site Management Plan (SMP).

 Ensures alignment of clinical activities to budget, including identification of out of scope activities.

 May participate in business development proposals, defense meetings and proposal development.

 As required, provides development and delivery of initial and ongoing training to the study team regarding protocol specificity's, Case Report Form (CRF) completion, Sponsor Standard Operating Procedures (SOPs), clinical plans and guidelines, data plans and timelines for the study. Plans and leads regular clinical study team calls to provide status updates, ongoing training and accountability to deliverables.

 Reviews the content and quality of site monitoring documentation (site monitoring calls, site visit reports, site letters, and pertinent correspondence), to ensure they represent site management activities and conduct. Ensures these deliverables are provided according to delivery deadlines.

 Understands the monitoring strategy required for the study and where required participates in the development of the study risk assessment plan. Is accountable for the clinical teams understanding, ongoing compliance and delivery according to the stated monitoring strategy, CMP/SMP, and risk plans.

QUALIFICATION REQUIREMENTS

 Bachelor's degree or RN in a related life science field or equivalent combination of education, training and experience
 Demonstrated ability to lead and align teams in the achievement of project milestones, demonstrated capability of working in an international environment.
 Knowledge of basic clinical project financial principles
 Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
 Excellent communication, presentation and interpersonal skills.

To apply please share your CV or call Candice Howells on 02 9431 2565

Please send your Cover Letter and Resume in Word Doc Format (no text boxes or tables please) and follow the Apply Links. Visit onqrecruitment.com.au to review all our current vacancies.

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