Senior Central Monitoring Manager

Reporting to the Director of Clinical Data - Central Monitoring and Oversight, the Senior Manager will be responsible for utilizing various RBQM technologies to perform aggregate clinical trial data reviews. The role involves identifying potential outliers, anomalies, and trends, and leading team calls to report and discuss findings.

Responsibilities

• Perform aggregate clinical trial data review using different technology solutions and present potential findings (trends/issues/anomalies) in cross-functional team calls.
• Utilize critical thinking skills to identify potential issues and trends in critical data and processes, and discuss these with cross-functional teams.
• Employ AI/ML technology to identify trends in clinical trial data that require escalation to study teams.
• Collaborate with Risk Management, Data Management, and Clinical Systems to implement new central data monitoring technologies and analytics.
• Maintain standard libraries associated with central data monitoring activities, including metrics, TSDV specifications, and critical data.
• Understand the use, definitions, and specifications of KRIs and QTLs in clinical trials, providing guidance and confirmation that calculations are accurate.
• Support programming and maintenance of clinical data oversight metrics, including KRIs and QTLs, within technologies using company standards.
• Manage and communicate project priorities and timelines concerning the provision of technology and central data monitoring solutions.
• Develop targeted source data verification specifications and perform UAT of tSDV functionality.
• Train study teams on standard processes across therapeutic areas for central data monitoring.

Essential Skills

• Bachelor’s Degree in a relevant science-based discipline is highly preferred.
• At least 5 years of experience in data science, central clinical data monitoring, or clinical operations within the industry, with experience across indications and EDC platforms.
• Deep understanding of drug development and the biopharmaceutical industry.
• Extensive knowledge of the RBQM process, including thorough command of FDA and ICH GCP guidelines.
• Strong technical skills utilizing industry data visualization and central data monitoring technology solutions such as CluePoints, Medidata DETECT, PerkinElmer Spotfire, Tableau, and eClinical Solutions.
• Experience in regulatory GCP inspections/audits.

Additional Skills & Qualifications

• Demonstrates leadership, problem-solving, conflict resolution, and team-building skills.
• Ability to establish effective business relationships with external stakeholders.
• Proven ability to manage multiple competing priorities.
• Must thrive in a fast-paced, innovative environment while remaining flexible, proactive, resourceful, and efficient.
• CluePoints experience is essential.
• Elluminate experience is a plus, but not required.
• CRO experience is acceptable.
• Ability to independently manage studies.

Work Environment

This is a remote position with a requirement to align with East Coast hours. The role involves working 40 hours per week, and candidates can be located in either the Eastern or Central time zones.

This is a Contract position based out of Cambridge, MA.

The pay range for this position is $145000.00 - $145000.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

This is a fully remote position.

This position is anticipated to close on Apr 17, 2026.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is 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

Actalent is an equal opportunity employer.

About Actalent

Actalent is a global leader in engineering and sciences services. For more than 40 years, we’ve helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC—with four delivery centers in India led by 1,000 extraordinary employees who connect their passion with purpose every day.

Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.

Salary : $145,000