Director Clinical Operations - Iqvia Biotech Europe

IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.

IQVIA Biotech, a global full service CRO providing flexible, tailored, integrated clinical solutions is pursuing top talent for a new Clinical Operations Director for a Risk Based Monitoring program!! This position will work remotely, giving the opportunity for high touch and visible progress to positively impact the monitoring department. 

Job Description Summary

• Risk Based Monitoring experience essential to provide support to study teams with the set up and implementation of RBM solutions for IQB
• Support/participation for proposal/budget development and client business development discussions concerning RBM and CM activities.
• RBM Oversight for RBM implementation/questions/support for IQB
• Development of RBM training materials for IQVIA Biotech
• Audit support concerning RBM implementation
• Support for BDM preparation where RBM to be implemented

Future Technology Enablement

• Close interactions with the relevant product owners and IQB stakeholders (IQVIA Biotech Focus Group, CM Quality and Training)
• Technology Enablement through adoption of cloud based RBM platform, CTMS and CRA Central
• Change management, process adjustments, costing
• Support CM Quality Document development/revisions

Key and essential skills for this position:

• Must have extensive experience with Risk Based Monitoring.
• Well versed knowledge of clinical operations, clinical site activity, the monitoring process and study management.
• This position will not have any direct reports but rather manage a project of technical adoption. The role will manage the RBM tool they are presenting to the client or cross functional groups.
• Will be interacting and communicating with executive leadership such as, Sr. Directors/VPs/Program Directors…etc.
• There is not a specific therapeutic area that is required however candidates must have knowledge/experience with complex and challenging protocols. Experience with a variety of therapeutic areas would be a plus.
• Other skills needed: Risk Based Monitoring is a MUST along with strong technical knowledge, change management, excellent communication skills, site operations and confident decision making skills.

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