Apply clinical research expertise in multiple initiatives by working directly with various stakeholders and ensuring process and practice methodology is applied consistently and in accordance with SOPs, policies, good clinical practices and applicable regulatory requirements. 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. Mentor/ coach Clinical Process Associate/Specialist colleagues.
Implementation of specific process initiatives arising out of transformation/innovation/ process re-engineering programs
Act as clinical research subject matter expert for various initiatives
Supporting the creation of frameworks, collaterals, whitepapers and accelerators relevant to the areas of expertise.
Collaborate with respective stakeholders, including operations teams, global teams, and other functional managers as appropriate
Collaborating with peer business process specialists and promoting cross functional synergies.
Mentor projects/ initiatives on industry best practices
Process improvement initiatives – liaise with the IQVIA stakeholders and support teams to review and provide oversight
Competency development – Develop training content, deliver training and monitor the growth of the competency
Process development, process pilots and process transition of key business processes that will be transitioned and executed by the group
Develop and deploy competency assessments working with the Global training department
Work with the delivery team and provide functional support to the teams on an ongoing basis
Process Quality and audit initiatives – Identify impacted areas, provide root cause and implementation of corrective and preventive action
Develop templates, re-usable assets and best practices
Creation of business cases, proposals and presentations related to the relevant area of expertise
Review and sign off on project requirements, process flows, gaps, and design documents
Perform the User Acceptance Testing; ensure the quality of the deliverable is in line with what has been agreed in the project requirements
Work with Enablement group to test the platform perform user testing
Work with Quality management to develop the QM plan for the work stream
Bachelor’s degree in life sciences or related field and min 5 years with relevant clinical research experience; or equivalent combination of education, training and experience
Experience in clinical research field preferred.
Skills and Abilities
- Strong written and verbal communication skills including good command of English language.
- Advanced knowledge of clinical trial conduct, and skill in applying applicable clinical research regulatory requirements i.e. International Conference on Harmonization – Good Clinical Practice (ICH GCP) and relevant local laws, regulations and guidelines, towards clinical trial conduct.
- Good Clinical system expertise.
- Results and detail-oriented approach to work delivery and output.
- Understanding of clinical/medical data.
- Good motivational, influencing, coaching skills.
- Ability to work on multiple projects and manage competing priorities. In depth therapeutic and protocol knowledge.
- Strong organizational and problem-solving skills.
- Effective presentation skills.
- Demonstrated ability to deliver results to the appropriate quality and timeline metrics.
- Ability to work across cultures and geographies with a high awareness and understanding of cultural differences and maintain effective working relationships with coworkers, managers and clients.
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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