The IQVIA sponsor-dedicated **Clinical Functional Service Partnerships (Clinical FSP) **department is supporting our client’s project team in the execution of clinical trials. Joining the team provides the opportunity to manage Early Phase clinical research projects in different therapeutic areas and to cooperate closely with one of our key clients.
The Clinical Project Managers are an integral part of clinical trial delivery, liaising with clinical teams to improve patients’ lives by bringing new drugs to the market faster. **Clinical Project Management **is focused on project delivery, productivity and quality resulting in strong financial performance and customer satisfaction. Clinical Project leads can run their own studies. The Project Lead focus is on leveraging therapeutic expertise and IQVIA’s suite of solutions to drive operational excellence and strategic leadership with our customers.
Clinical Study Manager – Sponsor dedicated (Temporary backfill for employee on maternity leave)
Main Responsibilities
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Responsible for delivery and management of large, complex studies at the local level.
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Coordinate and ensure consistency of trainings, processes, and system related activities.
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Develop integrated study management plans with the core project team.
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Accountable for the execution of clinical studies at the local level per contract while optimizing speed, quality and cost of delivery and ensuring consistent use of study tools and training materials and compliance with standard processes, policies and procedures.
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Collaborate with other functional groups within the company where necessary to support milestone achievement and to manage study issues and obstacles.
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Monitor progress against contract and prepare and present project information proactively to stakeholders internally and externally.
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Manage risk (positive and negative) and contingencies proactively and lead problem solving and resolution efforts.
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Achieve project quality by identifying quality risks and issues.
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Build the cross-functional project team and lead their efforts; responsible for managing cross-collaboration of the core team and for overall project delivery to support milestone achievement and to manage study issues and obstacles.
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Ensure the financial success of the project.
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Forecast and identify opportunities to accelerate activities to bring revenue forward.
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Identify changes in scope and manage change control process as necessary.
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Serve as primary liaison for clinical monitoring issues, interacting with relevant team members and vendors and escalating as required.
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May be assigned as the primary contact for vendors leading project vendor management and vendor management related activities as per project requirements.
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Support staff development and mentor less experienced project team members on assigned projects to support their professional development.
Required Skills and Qualifications
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Bachelor's Degree Life sciences or related field
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At least 3 years of prior relevant experience in clinical research including a minimum of 2 years project management experience.
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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.
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Knowledge of Oncology and Hematology therapeutic area is required.
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Strong written and verbal communication skills including very good command of English language.
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Strong problem solving skills.
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Proven work experience in Vendor management and budget management.
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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.
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Ability to make decisions, bringing clarity to disparate information to inform actions and drive results.
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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.
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Ability to handle conflicting priorities.
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Results-oriented approach to work towards delivery and output.
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Good software and computer skills, including MS Office applications.
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Ability to establish and maintain effective working relationships with coworkers, managers and clients. Strong customer service skills.
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 https://jobs.iqvia.com
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.