The Start Up Project Manager is responsible for defining, developing and delivering the Global Study Start Up Project Plan by partnering with the Global Study Manager, Clinical Trial Application Group, Country Study Operations Manager, and others as required for all assigned interventional studies up to 100% sites activated

Partners with Optimization Analytics & Recruitment Solutions to leverage site intelligence to inform the Start Up Project Plan and ensures alignment to the Decision View Study Optimiser scenario planning.

Partners with Clinical Trial Application and operational Start Up functions to align all country and site activities to Start Up Project Plan.  Agrees to deliverables on a site-level basis with the Country Study Operations Manager and monitors adherence to these.

Leverages all available intelligence to inform the Study Start Up Strategy

Identifies risks to site activation and develops site activation mitigation plans and monitors effectiveness through the Study Start Up Subteam. This role is accountable for resolution of Site Activation escalations.  

Leads the Start Up Sub team, is a core member of the Study Management Operations Sub team and is an ad-hoc member of the Core Team Meeting throughout study start up.

Partnering with the Country Operations Manager, ensures accelerated Start Up for all sites leveraging the in-country start-up operations colleagues and external colleagues as applicable to ensure all sites are activated and “Ready to Enrol”.

• Understands critical path activities at the site level
• Ensures planning for individual components of the Investigator Initiation Package documentation (including site contracts and budgets and Informed Consent Document) in partnership with Country Operations Study Manager and in-country Start Up operations colleagues
• Ensures site readiness activities are considered in the overall timelines for each site to ensure ready to enrol

Uses the site activation reporting tool following site ID, up to and including, site Ready to Enrol

Identifies improvements and efficiencies to site activation processes and shares lessons learned broadly with key stakeholders

Qualifications

• Extensive global clinical trial/study management experience

• Working knowledge of Good Clinical Practices, monitoring, clinical and regulatory operations

• BS/Nurse – 5 years relevant experience or MS/PhD – 3 years relevant experience

• Prior Experience: demonstrated knowledge of site selection, site activation, site readiness interdependencies

• Demonstrated experience leading cross functional teams

• Demonstrated experience in Project Management activities and responsibilities

• Previous vendor oversight experience

• Technical expertise in the use of Site Activation tools

• Ability to manage complex processes and manage in a matrix environment

• Strategic Planning, Analytical and Problem-Solving Skills

• Country level awareness and strong interpersonal skills

• Excellent communication skills, both written and verbal. Must be fluent in English.

• Proficiency in Microsoft Office Suite

  
Work Location Assignment: Flexible

At Pfizer we care about our colleagues’ wellbeing and offer a range of great benefits for them, including:

• Paid parental leave

• Access to Health & Wellness apps

• Career Growth Experiences program

• Recognition & rewards program

• Paid volunteer days

• Life Insurance Benefits

• Pfizer Learning Academy access to top content providers

• Access to flu vaccines & skin checks

• Options to purchase additional leave

• Salary packaging & novated lease options

*Benefits listed may vary depending on your position and location and may be subject to change.

Pfizer Australia and New Zealand’s diverse workforce represents the patients we serve and the communities in which we operate. With a focus on Diversity, Equity & Inclusion (DE&I), Pfizer ANZ ensures our people are heard and cared for. We offer engagement opportunities in both Colleagues Resource Groups (CRGs) and workstreams across: Culture and Tradition, Reconciliation @ Pfizer (RAP), Gender Equity (GEN), Disability and through the Out Pfizer Employee Network (OPEN) for our LGBT + colleagues and allies.

If you require reasonable adjustment during your application, please reach out to the Talent Acquisition Manager.