Manage operational elements and execution of clinical studies at IQVIA, ensuring delivery, time, quality, and customer satisfaction since pre-award to close-out.
Responsibilities
Manage and support the operational elements and execution of studies and/or programs to ensure delivery; time and quality resulting in strong financial performance and customer satisfaction and in accordance with SOPs; policies and practices from pre-award to close-out.
Work with study(ies)/program(s) teams to focus on leveraging deep therapeutic expertise and IQVIA solutions to drive operational excellence and strategic leadership with our customers.
Participate in bid defense preparations.
Lead bid defense presentations in partnership with Business Development for large sized, multiple and full service, multiple country and/or multi regional studies.
Understand project strategy and operationalise the agreed upon approach.
Develop and/or support on the preparation of integrated study management plans in collaboration with the core project team.
Accountable for the strategic development and execution or delivery of clinical studies in line with agreed upon contracts while optimizing speed, quality and cost of delivery, ensuring consistent use of study tools and training materials and compliance with system updates, standard processes, policies and procedures.
Serve as primary project oversight and/or contact with customers and own relationship with the project’s key customer contact(s), communicate/collaborate with IQVIA business development representatives as necessary.
Set objectives for the core project team according to agreed upon contract, strategy and approach, effectively communicate and assess performance, providing feedback and leadership.
Collaborate with other functional groups within the company where necessary to support milestone achievement and to manage study issues and obstacles.
Monitor progress against contract and prepare/present project information proactively to all stakeholders internally and externally.
Supervise problem solving and resolution efforts to include management of risk, contingencies and issues.
Take accountability for proactive contingency plans to mitigate risks.
Coach and/or mentor junior team members around project delivery, planning, project review, risk management and problem solving to ensure global alignment of work practices across the team.
Achieve project quality by identifying and proactively managing quality risks and issues, responding to issues raised by project team members and planning/implementing appropriate corrective and preventative action plans.
Ensure the financial success of the project including optimal management and assignment of resources to achieve project goals and profitability.
Forecast and identify opportunities to accelerate activities to bring milestones and revenue forward, implement appropriate actions to achieve.
Identify changes in scope and manage change control process, including securing customer agreement to financial and milestone updates as necessary.
Identify and communicate lessons learned and best practices to promote continuous improvement.
Requirements
Bachelor's Degree Life sciences or related field
Requires 10 years clinical research experience including 6 years of project management experience or equivalent combination of education, training and experience.
Knowledge of clinical trials - Knowledge of clinical trial conduct and skill in applying applicable clinical research regulatory requirements i.e. ICH GCP and relevant local laws, regulations and guidelines, towards clinical trial conduct.
Communication - Strong written and verbal communication skills including good command of English language Strong presentation skills.
Problem solving - Strong problem solving skills.
Leadership - Ability to work through others to deliver results to the appropriate quality and timeline metrics, monitoring/managing performance and providing feedback, experience productively partnering cross functionally and with customers to advance work effectively and efficiently.
Organisation - Planning, time management and prioritization skills Ability to organize resources needed to accomplish tasks, set objectives and provide clear direction to others, experience planning activities in advance and taking account of possible changing circumstances.
IT skills - Good software and computer skills, including MS Office applications including but not limited to Microsoft Word, Excel and PowerPoint.
Finances - Good understanding of project financials including experience managing, contractual obligations and implications.
IQVIA Core Competencies - Ability to demonstrate all IQVIA competencies (Client Focus, Collaboration, Communication, Innovation and Ownership).
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