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CTI Clinical Trial and Consulting Services · 22 hours ago

Exec Dir Regional Clinical Monitoring

Covington, KY

Full-time

Onsite

Director/Executive

15+ years exp

CTI Clinical Trial and Consulting Services is a company focused on clinical trial management and consulting. They are seeking an Executive Director for Regional Clinical Monitoring to lead and oversee clinical trial site management, ensuring high-quality monitoring practices and collaboration with cross-functional teams.

BiotechnologyConsultingPharmaceutical

Growth Opportunities

Responsibilities

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

Qualification

Clinical MonitoringFinancial AcumenRegulatory KnowledgeLeadershipProcess ImprovementClinical SystemsBudget ManagementTeam SupervisionMulti-Cultural EnvironmentMentorshipCross-Collaboration

Required

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

Experience with use of clinical systems (Clinical Trial Management System [CTMS], electronic data capture [EDC], electronic Trial Master File [eTMF], etc.) used in clinical trials and process improvement surrounding use of technology to improve efficiencies

Benefits

We support career progression – 25% of our global staff is promoted annually and we have a structured mentoring program to provide the support you need to move forward

We value education and training – We provide tuition reimbursement, partner with universities and colleges to create programs in our field, and have a dedicated training department

We value our people - We have never had a layoff in our 20-year history, support a work-life balance with flexible schedules, and have provided cash bonuses every year for the past decade

Our culture is unparalleled – Click here to learn more about “The CTI Way”

We think globally and act locally – We have a global philanthropic program supporting our team’s efforts to improve their local communities (Click here to learn more about our “CTI Cares” program)