Job Title: Associate Director of Centralized Monitoring

Job Description

We are seeking an Associate Director of Centralized Monitoring who will serve as a Subject Matter Expert (SME) in Risk-Based Quality Management (RBQM). The successful candidate will be responsible for building visual dashboards, understanding Key Risk Indicators (KRIs), and performing as the Clinical Team Lead (CTL) of the centralized monitoring team. This role involves oversight of clinical operations activities and collaboration with various departments to support clinical trial activities.

Responsibilities

• Oversee clinical operations activities including clinical project management, clinical site management, and clinical systems management.
• Support government or commercial contracts in multiple therapeutic areas such as infectious disease, oncology, and medical devices.
• Manage project deliverables within budget and timelines for complex drug development programs.
• Communicate effectively in a matrix management organization and represent the clinical team during cross-functional collaboration.
• Provide operational expertise to support program/project level functional areas.
• Collaborate with directors and other departments on clinical operations strategy and vision.
• Inform division leadership on the status of clinical programs/projects and potential issues.
• Ensure documentation of processes and workflows within projected timelines and propose solutions to improve efficiency and quality.
• Support and comply with the company’s Quality Management System policies and procedures.
• Drive innovative project and company performance improvement solutions, including corrective and preventive actions.
• Perform risk-based quality content reviews and monitor internal/external KPIs.
• Contribute to corporate initiatives such as process improvement and SOP development.
• Manage staff hiring activities and resource management for the clinical operations department.
• Participate in proposal writing, budget development, and bid defense meetings for government and commercial clients.
• Support inspection readiness and assist in department audit preparation and follow-up activities.
• Oversee Risk-Based Quality Management and Centralized Monitoring processes for applicable clinical trials.
• Review protocols to ensure the set-up, review, and reporting requirements for KRIs and QTLs are standardized.
• Provide technical oversight and coordination for central monitor activities.
• Perform central monitoring activities including reviewing system outputs and proposing suggestions for signal and action management.

Essential Skills

• Broad multidisciplinary understanding of pharmaceutical clinical research and development processes.
• Hands-on experience in regulatory, clinical operations, or clinical trial monitoring/management.
• Ability to mentor staff and achieve high-quality performance through risk management and implementation of corrective/preventive actions.
• Strong facilitation, presentation, problem-solving, and conflict resolution skills.
• Excellent oral and written communication skills with strong attention to detail.
• Experience in the use and development of clinical research databases/systems/tools.
• Strong leadership skills including change management, people development, strategic thinking, and influencing.
• Advanced ability to manage team resources to ensure attainment of department objectives.
• Expertise in Microsoft Word, PowerPoint, and Excel, with experience in Microsoft Project.
• 10 years minimum experience in the pharmaceutical or biotechnology industry, including at least 6 years of project management or equivalent clinical trials and operations management experience.

Additional Skills & Qualifications

• Proposal writing and bid defense skills.
• Background in Infectious Disease/HIV clinical trials and/or Oncology.
• Experience in the conduct of Phase 1 protocols or prior work on a government contract.

Work Environment

100% Remote

Pay and Benefits

The pay range for this position is $135000.00 - $175000.00

Benefit
Description
Health
• Medical Insurance - Preferred Provider Organization (PPO)
• Prescription Drug
• Dental
• Vision
• Flexible Spending
• Dependent Care
• Health
• Life Insurance
• LTDInsurance
(Eligibility for health benefits is the first month following the date of hire.)
Retirement
• Pre-tax salary deferrals from 1% - 50%
• Company match
• Discretionary profit-sharing distribution
(Eligibility for the 401(k) plan starts after 30 days of employment.)
Leave
• 15 days per year (5.00 hours per pay period)
(See the adjacent table for increases based on tenure.)
Holidays
• 10 Company Recognized Holidays
Additional Benefits
• Tuition Assistance
• Professional Development
• Corporate Membership Rate at Sport & Health Clubs

Workplace Type

This is a fully remote position.

Application Deadline

This position will be accepting applications until Jan 3, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

Salary : $135,000 - $175,000