Exec Dir Regional Clinical Monitoring Job Covington area,Kentucky USA,Management

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What You’ll Do >

Lead regional CM staff for high-quality site management and monitoring of clinical trials.

Serve as senior internal CM contact for engagement with other company leaders and client representatives.

Provide strategic direction for the function in the region in concert with CM’s global functional vision and strategy.

Collaborate with CTI cross‑functional leaders to ensure monitoring practices work effectively with processes and procedures followed by other teams and geographies.

Meet regularly with the VP of Global Clinical Monitoring and global peers to share relevant updates, address challenges, and formulate shared solutions.

Drive process improvement for CM performance, quality, and efficiency in region.

Align with and make sure delivery is aligned with operational, productivity, and financial metrics, including adherence to trial budgets and time tracking expectations.

Oversee new CM processes and CTI initiatives to boost regional performance and profitability.

Utilize Business Intelligence © (BI), KPIs, and metrics to monitor trends, mitigate risks, and support trial and personnel success.

Lead discussions to refine procedures that improve monitoring quality and efficiency in a manner that facilitates greater efficiency and effectiveness across CTI’s trial functions.

Partner with Quality Assurance and other departments to update and maintain CM SOPs, keeping them current with CTI and industry advancements.

Participate in trial team meetings, sponsor meetings, and client governance discussions to provide guidance and oversight.

Lead by example in supporting staff development, career path planning, and organizational growth within the region.

Provide feedback to CRA Management for consistent policy and performance management implementation.

Collaborate with HR on talent acquisition and candidate evaluation, using every opening as an opportunity to elevate the talent of the organization.

Work with the Resource Management Group to allocate trial personnel within the region for optimal delivery on trial and general resource utilization.

Represent CM in bid defenses and strategic discussions for new business opportunities.

Contribute to the development and review of RFPs and budgets for trials.

Ensure timely escalation of CM issues to executive leadership.

Ensure consistent monitoring quality and adherence to applicable regulations and best practices across the region.

Oversee CRA assessment visits and ensure feedback is communicated to relevant stakeholders.

Identify actions for monitoring trends resulting in CAPAs and quality concerns for the region.

What You Bring

Demonstrate exceptional leadership to create a positive, cross‑collaborative work environment that fosters a culture of excellence through staff support, training, engagement, mentorship and innovation.
Successful track record in supervising, mentoring, and coaching teams on a large scale (i.e., over 100 team members).
Demonstrate financial acumen and ability to manage study and department budgets.
Demonstrate competency in leading cross‑functional process improvement efforts.
Strong computer skills to include MS Office (Word, Excel, PowerPoint) and ability to effectively utilize trial systems to positively impact effective trial management.
Ability to work in fast‑paced, cross‑border, multi‑cultural environment with several competing priorities.
Demonstrate extensive knowledge of global regulatory requirements (GCP/ICH) related to trial management in assigned geographical regions.
Able to interpret and analyze CTI financial reports at both study and regional levels, providing leadership to clinical monitoring teams to achieve financial goals at both the trial and departmental level.
At least 15 years of experience in pharmaceutical/biotechnology field, with progressive positions in Clinical Monitoring.
Bachelor's degree in allied health fields such as nursing, pharmacy or health science, preferably with clinical trial management experience or an equivalent combination of education and relevant work experience.
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