CENTRALIZED MONITORING LEAD
Descripción de la oferta de empleo
The CML has particular focus on leading/advising the centralized team (centralized monitors and centralized monitoring assistants) towards solutions to clinical risks identified and facilitating successful implementation of those strategies to address the issues.
Facilitate efficient and effective review of Site Visit Reports and assure consistent standards of implementation for quality to meet or exceed quality standards.
Ensure subject safety, data integrity, escalation of issues and timely and responsive feedback in compliance with IQVIA standard operating procedures, International Conference on Harmonisation - Good Clinical Practice (ICH GCP) guidelines, protocol requirements and regulatory compliance.
To provide expertise support in the Centralized monitoring studies from Applications, Analytics and Therapeutics or Quality perspective.
Key Responsibilities Project Oversight.
Oversee clinical deliverables on assigned projects, manage project resources, and coordinate efforts of cross-functional project teams.
Quality Assurance.
Ensure subject safety, data integrity, and compliance with relevant regulations and guidelines.
Conduct regular quality checks and manage audit initiatives.
Communication.
Act as a point of contact for assigned deliverables and establish effective project/site level communications.
Risk Management.
Identify and mitigate risks associated with project deliverables.
Monitor site performance and recommend corrective actions.
Mentorship.
Act as a mentor for junior staff and Technical Solution Specialists.
Training.
Act as a Subject Matter Expert to support departmental training.
Qualifications Bachelor’s degree in life sciences or related Minimum of 5 years of relevant experience of clinical trial experience.
Past or current CRA or In-House CRA experience is highly valued.
Formal or informal leadership experience Advanced knowledge of clinical trial conduct and applicable clinical research regulatory requirements.
Strong written and verbal communication skills.
Ability to work on multiple projects and manage competing priorities.
Strong organizational, problem-solving, and decision-making skills.
Ability to work across cultures and geographies.
#LI-Remote 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.
qvia.
om
Detalles de la oferta
- IQVIA
- Sin especificar
- 02/07/2024
- 30/09/2024
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