Clinical Site Manager

The Clinical Research Site Manager oversees the daily operations of a clinical research site and ensures the successful execution of multiple clinical trials. This role provides strong operational leadership, drives regulatory compliance, supports patient recruitment and retention, and manages key relationships with sponsors, CROs, and vendors. The position is ideal for an experienced clinical research professional who is ready to step into full site management after serving in a lead role at a research site or similar environment, and who is passionate about high-quality research and patient safety.

Responsibilities

• Provide leadership and oversight of day-to-day clinical trial operations across multiple concurrent studies.
• Ensure all studies are conducted in accordance with study protocols, sponsor requirements, Good Clinical Practice (ICH-GCP) guidelines, FDA regulations, and applicable federal and institutional requirements.
• Design, implement, and refine operational processes to improve site efficiency, patient enrollment, retention, and overall study execution.
• Collaborate closely with investigators, clinical research coordinators, regulatory personnel, and sponsors to achieve study milestones on time and within quality standards.
• Oversee patient recruitment and retention strategies to meet or exceed enrollment targets.
• Analyze recruitment metrics and trends, and implement process improvements to maximize patient participation.
• Work with study teams to identify barriers to enrollment and develop effective mitigation strategies.
• Serve as the primary operational liaison with sponsors, CROs, monitors, and external vendors, ensuring clear and proactive communication.
• Foster strong sponsor and vendor relationships through responsiveness, transparency, and consistently high-quality study execution.
• Coordinate and support sponsor and CRO activities, including site qualification visits, site initiation visits, monitoring visits, audits, and other on-site or remote assessments.
• Ensure ongoing compliance with Good Clinical Practice (ICH-GCP), FDA regulations and guidance, 21 CFR Parts 11, 50, 54, 56, and 312 as applicable, Institutional Review Board (IRB) requirements, and sponsor protocols and standard operating procedures.
• Oversee regulatory documentation and essential study files to maintain continuous audit readiness.
• Support internal quality assurance initiatives, including corrective and preventive action (CAPA) activities when issues are identified.
• Maintain accurate, complete, and contemporaneous source documentation for all study participants and procedures.
• Ensure data integrity and timely data entry within Electronic Data Capture (EDC) systems.
• Review study documentation and data for quality, consistency, and adherence to protocol and regulatory requirements.
• Supervise and mentor clinical research coordinators and other site staff, providing regular guidance and feedback.
• Support training and professional development initiatives for site personnel to enhance skills and maintain regulatory and procedural competence.
• Promote a culture of accountability, collaboration, continuous improvement, and research excellence across the site.
• Manage multiple studies simultaneously while maintaining high standards of quality, compliance, and patient safety.
• Contribute to process improvement initiatives that optimize clinical operations, documentation practices, and site performance metrics.

Essential Skills

• Minimum of 5+ years of clinical research experience, including site-level operations and study management responsibilities.
• Demonstrated expertise in Good Clinical Practice (GCP) and ICH-GCP guidelines.
• Strong knowledge of FDA regulations and 21 CFR requirements, including Parts 11, 50, 54, 56, and 312 as applicable.
• Proven experience with regulatory compliance, audit preparedness, and maintaining essential study documentation.
• Hands-on experience with source documentation practices and Electronic Data Capture (EDC) systems.
• Demonstrated success in patient recruitment and enrollment strategies for clinical trials.
• Experience managing sponsor and vendor relationships, including sponsors, CROs, monitors, and external vendors.
• Proven ability to manage multiple clinical studies simultaneously while maintaining quality and compliance standards.
• Strong leadership skills with experience supervising or leading clinical research staff.
• Excellent communication skills, both written and verbal, with the ability to interact effectively with internal teams and external partners.
• Exceptional organizational skills and attention to detail in managing documentation, timelines, and competing priorities.
• Strong problem-solving and critical-thinking abilities to address operational challenges and enrollment barriers.
• Bachelors degree in Nursing, Health Sciences, Biological Sciences, or a related field.

Additional Skills & Qualifications

• Nursing degree (BSN or equivalent) is preferred.
• Certification as a Certified Clinical Research Professional (CCRP) is preferred.
• Experience managing clinical research teams and overall site operations.
• Prior experience supporting pain management, analgesic, or pain-related clinical trials.
• Experience participating in FDA inspections, sponsor audits, or internal quality initiatives.
• Familiarity with Clinical Trial Management System (CTMS) platforms and other clinical trial technologies.
• Demonstrated competencies in operational leadership and driving site performance.
• Strong regulatory expertise and comfort working in highly regulated environments.
• Proven relationship management skills with sponsors, CROs, vendors, and investigative teams.
• A patient-centric mindset with a commitment to patient safety, ethical conduct, and high-quality care.
• Focus on process improvement and willingness to refine workflows for greater efficiency and quality.
• Ability to develop, coach, and support team members professional growth.
• High level of attention to detail and accuracy in all aspects of clinical trial conduct.
• Motivation to take the next step into full management responsibility after serving in a lead role at a site or similar research setting.

Work Environment

This is an onsite position based in Pasadena, MD, working within a dedicated clinical research site environment. The role involves close collaboration with investigators, clinical research coordinators, regulatory staff, sponsors, CROs, and external vendors in a professional clinical and office setting. You will work directly with clinical trial technologies such as Electronic Data Capture (EDC) systems and Clinical Trial Management System (CTMS) platforms, as well as standard clinical and office equipment. The work environment emphasizes regulatory compliance, patient safety, teamwork, and operational excellence, providing a strong platform for professional growth in clinical research site management.

Job Type & Location

This is a Contract to Hire position based out of Pasadena, MD.

Pay And Benefits

The pay range for this position is $45.00 - $70.00/hr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

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)

Job Type & Location

This is a Contract to Hire position based out of Pasadena, MD.

Application Deadline

This position is anticipated to close on Oct 16, 2026.

Workplace Type

This is a fully onsite position in Pasadena,MD.

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 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

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 [email protected] 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.