Senior Project Management Analyst, Study Operations, Cronos

Job Overview Project Management Analysts (PMA) are an integral part of clinical trial delivery, liaising with project teams to improve patients’ lives by bringing studies to the market faster. The Sr. PMA works in close partnership with the Project Leader (PL) / Clinical Project Manager (CPM) driving project management activities to mitigate risk, control cost, manage project schedule, and ensure customer satisfaction related to assigned project / s.

Responsibilities Establish and manage performance dashboards, analyze event triggers / alerts, and determine appropriate follow up for project leader (PL) or others to act upon.

Manage project schedule and ensure timely updates of all key milestones and partner with PL on related calls.

Coordinate and lead risk and issue management process. Schedule and lead regular check-ups (at least monthly) and, as milestones / events occur throughout the project lifecycle, review project and operational risks. Assess and update impact, probability, and detectability, as needed. Identify risks that can lead to process improvement / standardization across the organization and proactively drive the implementation of process improvements related to these.

Demonstrate expert knowledge of all finance systems. Manage all aspects of the Project Finances including Estimate at Completion (EAC), monthly expenses, invoices, and reconciliation.

Proactively identify Out of Scope (OOS) activities and implement and maintain change control processes.

Demonstrate compliance with the Vendor Management Plan and Purchase Order (PO) process and actively contribute to the creation and finalization of Vendor Management Plan. Assess risks related to vendors and ensure that appropriate owners, mitigation, and response plans are recorded in the project Risk Log.

Proactively and on time provide data to PL on areas including cost, schedule, scope, utilization, change orders and quality to ensure better decision-making.

Independently develop and maintain relevant sections of Project Management Plans. Provide practically viable innovative ideas for upgrading Project Management related systems and work with teams to support implementation.

Review and support project resource allocation within project budgeted for assigned portfolio / projects.

Prepare correspondence, including meeting minutes, for project team and / or customer.

Organize and partner with PL in managing internal project team and customer meetings.

Prepare project status reports and presentation material for internal project team and customer meetings.

Lead and coordinate core study file reviews and support audits as needed. Drive eTMF filing compliance focusing on completeness, timeliness and quality, monthly. Mentor Project Management Analyst (PMAs) on active Trial Master File (TMF) management.

Manage project specific eTraining and oversee compliance for project team.

Coordinate and support onboarding of new Key Project Team Members and system access.

Monitor project metrics and make required updates in IQVIA systems to ensure accurate and timely reporting is available to senior management.

Participate in regional and global initiatives to support PMA community and aid personal development.

Mentor less experienced PMAs in all PMA aspects.

Qualifications Bachelor’s Degree in life sciences or other related field required.

Typically requires 3 years of prior relevant experience in project management and clinical research with analytical / financial skills.

Requires knowledge of principles, theories, and concepts of a job area, typically obtained through advanced education.

Knowledge of clinical trials - strong knowledge of clinical trial conduct and skill in applying applicable clinical research regulatory requirements i.e. ICH, GCP, and relevant local laws, regulations, guidelines towards clinical trial conduct.

Strong written and verbal communication skills including good command of English language.

IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at IQVIA, we believe that diversity, inclusion, and belonging empower our mission to accelerate innovation for a healthier world. We create a culture of belonging by valuing the perspectives of all talented employees worldwide and providing them with the opportunity to power smarter healthcare for everyone, everywhere. When our talented employees bring their authentic selves and their diverse experiences to work, they enable us to accomplish extraordinary things. Multifaceted thought processes spark innovation. Multi-talented collaboration harnesses innovation to deliver superior outcomes.

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