Associate Director, Monitoring Services

Associate Director, Monitoring Services

US Remote Worker

The Emmes Company, LLC ("Emmes") is a global, full-service Clinical Research Organization dedicated to excellence in supporting the advancement of public health and biopharmaceutical innovation. We believe in the power of truth, so much so that we named our company Emmes, which means truth. Through decades of experience we have learned that collaborative relationships thrive and human health benefits when truth is our compass.

Our "Character Achieves Results" culture is driven by five key values that guide our actions in the way we conduct research and distinguish us as an organization: Integrity, Agility, Passion for Excellence, Collaborative Partnerships and Intellectual Curiosity. We are a trusted partner to clients who share our passion for improving public health in a world of ever-changing scientific research.

If you share our motivations and passion in research, come join us! You will be joining a collaborative culture that empowers every Emmes employee — from entry level through top executive — to contribute to our clients' success by sharing ideas openly and honestly.

Primary Purpose

The Associate Director, Monitoring Services reports to the Director or Senior Director, Monitoring Services and is responsible for supporting the Director/Senior Director in the leadership of the Monitoring Services Department. The Associate Director, Monitoring Services supports Emmes' mission of shedding light on important human health problems by providing the highest quality and focused site monitoring and management to Emmes' projects and its corresponding sponsors.

Responsibilities

• Coordinates the activities of the Monitoring Services department in consultation with the Director/Senior Director, Monitoring Services
• Leads the resourcing and project placement of Monitoring Services staff members across global projects.
• Supports the Director/Senior Director, Monitoring Services in developing, tracking the status of, and achieving corporate department goals
• Supervises and develops Monitoring Services Managers, provides mentorship and training to department management staff, conducts annual reviews/salary reviews/bonus reviews.
• Collaborates with global Monitoring Services and other regional leaders to provide strategy input and department status updates to regional and global Monitoring Services Heads.
• Leads the hiring and onboarding processes of monitoring services staff and participates in the interviewing and decision making of potential talent.
• Develops, implements, and manages an extensive Monitoring Services training and quality assessment program including development of department-related processes/SOPs, content, training activities, and management of an assessment schedule that meets quality standards and organizational needs.
• Collaborates with corporate Training and Development department for ongoing creation and evaluation of the training curriculum, training modalities for training and training assessments. Develops and implements training programs that include required role, disease-area, regulatory, and technology standards
• Creates and develops team of qualified staff to conduct global Monitoring Services staff assessment visits.
• Responsible for Monitoring Services onboarding and monitoring total training time allocations and timely completion of onboarding activities for Emmes staff and contractors.
• Coordinates and supports the preparation and follow up of local/regional inspection readiness activities.
• Develops and oversees training key performance indicators though the development, execution, and reporting of all pre, during and post training surveys and assessments globally.
• Evaluates effective training and management strategies on an ongoing basis.
• Provides support for Monitoring Services staff in audit preparation and resolution of audit action items.
• Serves as a point of escalation and collaboration for addressing client satisfaction or issues.
• Responsible for the quality, timeliness and delivery of direct report's deliverables and performance metrics including direct labor utilization, corporate training requirements and project deliverables.
• Serves as subject matter expert for Information Technology solutions (i.e. CTMS, eTMF, LMS, etc.). • Participates in corporate initiatives.
• Communicates corporate goals to the Monitoring Services department and models corporate culture through vision, action, and learning.
• Holds direct reports and staff accountable for high performance while promoting engagement and fostering a value-based culture of accountability.
• Identifies opportunities to improve service and increase quality and efficiencies.
• Supports and maintains Monitoring Services SOPs and Work Instructions that accurately reflect the standards of activities falling under the responsibilities of Monitoring Services staff.
• Supports Quality Assurance (QA) activities including CAPA resolution for Monitoring Services activities in a timely fashion and communicates proactively with QA representatives.
• Develops and manages department training and professional development budget.
• Maintains Monitoring Services department job descriptions and career paths and facilitates communication to Monitoring Services members through the Managers.
• Mentors and supports people development as appropriate.

Supervisor Responsibilities

• Directs and oversees recruitment, hiring, supervision, coaching, and evaluation of staff
• Develops, encourages, and provides ongoing education and professional development

Experience

• Bachelor's or Master's degree, preferable in a scientific discipline
• CCRA certification is a plus
• Incumbent typically will possess at least 5 years progressive CRA/CRA management experience
• Prior supervisory experience required
• Personnel management and project leadership highly desired
• Excellent oral and written communication skills.
• Strong interpersonal skills, a collaborator/team player, open minded to the diverse opinions of others.
• Strong analytical ability

Emmes is a federal government contractor and requires all employees to be fully vaccinated against COVID-19, to the extent permitted by applicable law. Individuals with medical conditions or sincerely religious beliefs or practices that prevent them from getting the vaccine may request an exemption from the vaccine requirement.

Why work at Emmes?

At Emmes, your actions and hard work will have a direct impact on public health initiatives, both globally and in our local communities with opportunities for volunteerism through our Emmes Cares community engagement program. We offer a competitive benefits package focused on the health and needs of our growing workforce, including:

• Unlimited Approved Leave

• Tuition Reimbursement

• 401k & Profit Sharing Plan

• Work From Home Anywhere in the US

• Maternal/Paternal Leave

• Casual Dress Code & Work Environment

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The Emmes Company, LLC is an equal opportunity affirmative action employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability, protected veteran status, genetic information, age, or other legally protected characteristics.