Area Study Start Up Lead

1 week ago

Sydney, New South Wales, Australia AbbVie Full time
Job Description

Job Summary:

The Area Study Start Up Lead is responsible for the on-time, budget, and quality delivery and execution of start-up and maintenance activities for assigned clinical studies within the area. This role reports to the Area SSU Head and serves as a single point of accountability for site start-up and maintenance activities.

Key Responsibilities:

  • Oversee and drive activities of Country SSU Specialists for assigned trials.
  • Identify and communicate issues impacting delivery and provide proposed solutions.
  • Work with Area and Country leadership to identify training needs of country start-up specialists and standardize training solutions.
  • Accountable for on-time, budget, and quality delivery and execution of start-up and maintenance activities.
  • Collaborate with key stakeholders to establish country/site activation plans, including risk assessments and mitigation planning.
  • Build country-level ICF samples, review IRB/EC comments, and route for approval.
  • Drive start-up activities, including site selection and activation, EC submissions, document collection, and query responses.
  • Provide area start-up updates and metrics to Area Director and Global SSU Leads.
  • Run area start-up meetings and drive priority action items.
  • Collaborate with Global Site Contracting & Purchasing and Supplier Management, CTS, and Regulatory Affairs to ensure alignment between contract execution, CA and EC submission activities, site training visits, and site activation planning.
  • Lead quality management through risk-based thinking for assigned studies.
  • Drive standardization in area start-up process and training, including sharing of best practices and lessons learned.
  • Maintain SSU performance metrics and KPIs for assigned studies.
  • Ensure audit/inspection readiness.
  • Ensure maintenance of intelligence database and Vault EDLs for countries and sites within the area.
  • Ensure compliance with corporate and divisional policies and procedures in alignment with worldwide regulations and guidelines.
  • Participate in process improvement initiatives as required.

Qualifications:

  • Bachelor's Degree required, degree in healthcare or scientific field preferred.
  • Minimum of 6 years of clinical research experience and preferably 4+ years of study start-up management experience for the designated region.
  • At least 2 years of experience in line management of people, coaching, and mentoring of staff and teams preferred.
  • Preferred exposure in study initiation through study completion in multiple phases of studies (Phase II and III, Phase I in patients).
  • Proven leadership skills in a cross-functional global team environment, experience in working with remote/virtual teams, and ability to influence and align stakeholders in a cross-functional, multicultural environment.
  • Strong analytical and critical thinking skills and ability to evaluate complex issues from multiple perspectives and drive smart decision-making.
  • Excellent interpersonal skills with ability to build trust and communicate persuasively and with clarity, flexibility, and adaptability to changing requirements.
  • Demonstration of successful program execution, preferably in start-up, and aptitude for managing multiple priorities in a fast-paced environment.
  • Demonstration of participating in successful initiatives, special projects, and activities that support the business.
  • Advanced working knowledge of ICH and GCP guidelines and operational understanding of the area regulatory environment.

About AbbVie:

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion. It is AbbVie's policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.

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