Project Director I

7 days ago

Australia Avance Clinical Pty Full time

About Avance Clinical Pty

Avance Clinical Pty is a leading Contract Research Organisation (CRO) that provides specialised services to support drug development for the pharmaceutical and biotechnology industry.

Job Summary

The Project Director I is responsible for planning and executing or overseeing projects by coordinating staff and processes to deliver projects on time, within budget, and with the desired outcomes while ensuring the trial is conducted in accordance with the protocol, company Standard Operating Procedures (SOPs), ICH GCP guidelines, and other applicable regulatory requirements.

Key Responsibilities

  • Project Management
    • Provide guidance and support to Project Managers and Project Associates to ensure high-quality project delivery across the following areas:
    • Effective Sponsor communication to proactively manage project timelines, expectations, risks, and issues.
    • Communication with internal cross-functional teams and external stakeholders (including third-party vendors and site staff) to execute projects within agreed timelines.
    • Development of appropriate study plans and documents to support the effective execution of all Project Management activities.
    • Consistent and accurate identification, management, and reporting of study-specific risks.
    • Project financial management, including revenue recognition, accurate forecasting, and contract management, sponsor invoicing, and vendor payment management.
  • Relationship Management
    • Develop effective relationships with assigned Sponsors to successfully manage sponsor grievances and drive strategic partnerships.
  • Team Management
    • Manage Project Manager and Project Associate resource assignments across the department in conjunction with the PD team, proactively projecting PM/PA resource need.
    • Monitor line reports' compliance with the use of expected company systems and processes, training completion, and timecard entry, leave entitlement administration, and expense processing.
    • Actively manage the performance of line reports and individual career development strategies.
    • Implement and support staff retention initiatives, drive staff recruitment (including interviews and probation period management), and manage staff severance.
  • Vendor Management
    • Autonomously manage all contracted services and vendors for clinical projects to ensure that projects are commenced and completed within defined scope, timelines, and budget.
  • Compliance and Quality
    • Participate in study-specific or vendor audits conducted by sponsors or regulatory agencies and respond to audit observations, as required.
    • Ensure Serious Adverse Events are reported (initial and follow-up) as per protocol requirements.
  • Professional Development
    • Provide guidance and mentoring to less experienced project management staff members and participate in training initiatives.

Requirements

  • Education
    • Bachelor's level degree in life sciences, pharmacy, nursing, or equivalent field.
  • Experience
    • Experience as a Project Director in a CRO or Pharma company, or previous experience as a Senior Project Manager in a CRO or Pharma company for at least 6+ years or experience with PD-type skills in a clinical trial service provider.
    • Experience in directly line managing staff – 2 plus years.
  • Skills and Knowledge
    • Previous training and a working knowledge of ICH GCP and applicable regulatory requirements.
    • Clear understanding of the requirement to adhere strictly to client confidentiality.
    • Effective written and oral communications skills, including the ability to keep clients, senior management, and other stakeholders informed of project updates and other pertinent information.
    • Demonstrated ability to take initiative in problem-solving and in exercising good judgment.
    • An understanding of Privacy Legislation as it applies to the Clinical Trial Environment.
    • Ability to work under pressure in a multi-disciplinary team environment.
    • Willingness to work in, and be supportive of, a positive and dynamic team culture.
    • Ability to travel. Minimal level of travel may be required (up to 20%).
    • Can build and maintain positive relationships with management, peers, and subordinates.
    • Ability to work independently or in a team environment as needed.
    • Display strong analytical and problem-solving skills.

What We Offer

  • Stimulating work
  • Project diversity
  • An intellectual challenge
  • An agile and flexible workplace
  • Opportunity to progress
  • Stability
  • Sense of community
  • A leadership team that are working together on a common goal
  • Flexible work options – you can work from home
  • Great tools / tech to do your job
  • A competitive salary & an extra day's holiday for your birthday

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