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Senior Consultant
Function: Regional Clinical Project Manager for observational and low interventional clinical trials.
Responsibilities:
- Participates or leads teams in the design, development and delivery of consulting projects or components of larger, complex projects.
- Reviews and analyzes client requirements or problems and assists in the development of proposals of cost-effective solutions that ensure profitability and high client satisfaction.
- Managing the operational aspects of observational and low Interventional clinical trials and representing project delivery with the customer.
- Produce and distribute status, tracking and financial reports for senior management.
- Responsible for tracking financial deliverables, reporting and invoicing on projects.
- Ensure appropriate subject recruitment plans are in place. Ensure the Site Recruitment Action Plan (SRAP), patient recruitment target and contingency plans are in place.
- Deliver the project / program according to the quality management plan. Guide CRAs and advise on critical specific study issues.
- Manage project set-up, maintenance and follow-up activities through ongoing tracking and review of project progress.
- Develop the risk management plan from and coordinate clinical issue escalation and resolution with the Sponsor.
- Developing or reviewing study management plans
- Collaborate with other functional groups such as Data Management and Biostatistics, where necessary to support milestone achievement and to manage study issues and obstacles.
- Utilize appropriate project tools and processes for the study team to support the execution of project deliverables.
Requirements:
- In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
- Proven ability to work through others to deliver results to the appropriate quality and timeline metrics
- Proven ability to understand customer needs and appropriately influence decision making
- Effective mentoring and training skills
- Ability to balance operational and strategic priorities
- Strong communication and interpersonal skills, including good command of English language
- Effective presentation skills
- Demonstrated proficiency in using systems and technology to achieve work objectives
- Demonstrated proficiency at analyzing data and information to make conclusions and drive sound decision making
- Strong organizational and problem-solving skills
- Demonstrated ability to deliver results to the appropriate quality and timeline metrics
- Good team leadership skills
- Ability to manage competing priorities
- Strong software and computer skills, including MS Office applications
- Ability to establish and maintain effective working relationships with coworkers, managers and clients.
Minimum Required Education and Experience:
Bachelor's degree in life sciences or related field and 7 years’ clinical research experience including 3 years’ project management experience.
IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com
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