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Study Process Lead

Sofía, Bulgaria R1449505

Sofía, Bulgaria| Bulgaria

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Descripción del puesto

Job Overview
Provide project related assistance for assigned project(s), sites and project teams. Lead teams functionally, where assigned, including awareness of scope of work, budget, and resources. Ensure all work is conducted in accordance with SOPs, policies and practices, good clinical practices and applicable regulatory requirements and meets quality and timeline metrics.

Essential Functions

  • Perform complex processes and tasks that eventually result in high quality deliverables that are completed according to service level agreements (SLAs) and within project timelines

  • Establish and maintain effective project/ site communications

  • Create and maintain relevant project documents

  • Ensure accurate completion and maintenance of internal systems, databases, tracking tools, timelines and project plans with project specific information

  • Review, evaluate and recommend modifications to designated processes

  • Participate in document management (creation, review, maintenance, storage, as applicable)

  • Participate in (study) team meetings and implement action items

  • Collaborate with the project lead/team members in creation/review of study documents

  • Setting quality standards and reviewing deliverables to the same for process tasks.

  • Coordinate and collaborate with various project stake holders.

  • Act as SME/mentor/buddy for new joiners and  support with system/process trainings.

  • May be assigned role of systems expert - guiding teams on using of systems, creating guidance documents, updating relevant trainings  and any new updates available in the systems.

  • Relaying the trainings to the team and be available to address the queries for the teams.

Qualifications

  • Bachelor's Degree Life sciences or related field Req

  • Typically requires Minimum 3 years of relevant experience.

  • Good knowledge of, and skill in applying applicable clinical research regulatory requirements; i.e., ICH GCP and relevant local laws, regulations and guidelines

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

  • Results and detail-oriented approach to work delivery and output

  • Good problem solving skills

  • Good planning, time management and prioritization skills

  • Ability to handle conflicting priorities

  • Attention to detail and accuracy in work

  • Good software and computer skills, including MS Office applications including but not limited to Microsoft Word, Excel and PowerPoint

  • Ability to establish and maintain effective working relationships with coworkers, managers and clients.

  • Proven ability to work on multiple projects balancing competing priorities

  • Good leadership skills

  • Ability to work across cultures and geographies with a high awareness and understanding of cultural differences

  • Setting quality standards and reviewing deliverables to the same for process tasks.

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

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