Central Monitor

The Senior Manager, Central Monitoring Contractor will be responsible for utilizing various Risk-Based Quality Management (RBQM) technologies to conduct comprehensive clinical trial data reviews. This role involves identifying potential outliers, anomalies, and trends in data and leading team discussions to address these findings. The position reports to the Director, Clinical Data - Central Monitoring and Oversight.

Responsibilities

• Perform aggregate clinical trial data review using different technology solutions and present potential findings in cross-functional team calls.
• Utilize critical thinking to identify potential issues and trends in critical data and process evaluations.
• Employ AI/ML technologies to detect trends in clinical trial data for 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.
• Understand and provide guidance on the use, definitions, and specifications of KRIs and QTLs in Clinical Trials.
• Support programming and maintenance of clinical data oversight metrics within technologies using company standards.
• Manage and communicate project priorities and timelines for technology and central data monitoring solutions.
• Develop targeted source data verification specifications and perform UAT of tSDV functionality.
• Train study teams on standard processes for central data monitoring.

• At least 5 years of data science, central clinical data monitoring, or clinical operations experience in the industry.
• Experience across indications and EDC platforms.
• Deep understanding of drug development and the biopharmaceutical industry.
• Extensive knowledge of RBQM processes, FDA, and ICH GCP guidelines.
• 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.
• Strong technical skills with data visualization and central data monitoring technology solutions such as CluePoints, Medidata DETECT, PerkinElmer Spotfire, Tableau, eClinical Solutions.
• Experience in regulatory GCP inspections/audits.

• Bachelor’s Degree in a relevant science-based discipline is highly preferred.
• Cluepoints Experience – mandatory.
• Elluminate Experience – a plus but not required.
• Hybrid role experience – central monitoring and oversight monitoring.
• Experience in therapeutic areas such as Infectious Disease, Rare Disease, Oncology is beneficial.
• Experience with up to 10 studies.
• Ability to independently manage studies.
• CRO experience is acceptable.

This is a remote position operating on East Coast hours, with flexibility to sit in either Eastern or Central time zones. The role requires a commitment of 40 hours per week. The workload is sustainable with long-term renewal expectations, offering a generous PTO and holiday package.

Job Type & Location

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 May 29, 2026.

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.

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.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.

Salary : $145,000