Clinical Team Lead

7 days ago

Sydney, New South Wales, Australia SYD Fortrea Australia Pty Ltd Full time

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, SYD Fortrea Australia Pty Ltd provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, SYD Fortrea Australia Pty Ltd is transforming drug and device development for partners and patients across the globe.

The Clinical Team Lead is accountable for execution and oversight of local operational clinical trial activities and has ownership, oversight and impact on local regulatory and financial compliance, at a country operations level at the client in compliance with ICH GCP and country regulations.

The position has a significant impact on:

  • how a country can deliver country-specific trial commitments and objectives especially during the study.
  • the ability to effectively conduct clinical studies and develop the pipeline, while maintaining local regulatory and compliance requirements in countries
  • how a country can deliver country-specific trial commitments and objectives.

Responsibilities, skills and duties:


PERFORMANCE: Accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, Client policies and procedures, quality standards and adverse event reporting requirements internally and externally. 30%

MANAGEMENT: POC for assigned protocols. Pro-actively drives/tracks execution and performance of deliverables/timelines/results to meet country commitments for assigned protocols. Strong collaboration with local CO roles. Forecasts country resource needs. Serves local business needs (signs contracts, manages budgets as delegated). 20%

QUALITY OVERSIGHT: Responsible for quality and compliance in assigned protocols in country. Oversees CRAs and CTCs on assigned projects. Oversees training compliance. Performs quality control visits. Reviews Monitoring Visits Reports and escalates performance issues and training needs to functional vendor and internal management as needed. 20%

EXTERNAL CUSTOMER FACING: Responsible for collaboration with functional outsourcing vendors, investigators, other external partners. Oversees country and site validations, site selection and recruitment in assigned protocols. Responsible for clinical trial education to sites. Country POC for programmatically outsourced trials for assigned protocols.20%

INTERNAL COLLABORATION & STRATEGY: Collaborates internally with local PV, Regulatory, GMA/GHH to align on key decisions in countries. Supports local and regional strategy development consistent with long-term corporate needs in conjunction with CRD and Regional Operations.10%

Experience:

  • Minimum 1 - 4 years of experience as a CTL, Project Manager or an equivalent combination of education and experience to successfully perform key responsibilities of the job.

Preferred:

  • Advanced CRA experience, on-site or in-house.
  • Global clinical project management experience.
  • In lieu of the above minimum requirement, candidates with three or more years of relevance clinical research experience in pharmaceutical, CRO or health care setting will be considered.

NOTE: this role requires someone to work from the office in Sydney at least 3 days per week

SYD Fortrea Australia Pty Ltd is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact.

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