Clinical Study Manager

The Clinical Study Manager is responsible for the delivery and execution of global clinical studies under the direction of a Study Delivery Lead. This role focuses on tactical study delivery, requiring excellent communication, project management skills, and attention to detail. The Clinical Study Manager interacts with key stakeholders to communicate project status, resolve issues, and troubleshoot inquiries. This position may involve both operational strategy and study execution.

Responsibilities

• Lead the clinical study operational aspects of planning, execution, and management of one or more Phase 1-3 clinical trials.
• Participate as a cross-functional study team member and liaise with other departments.
• Provide mentorship to junior Operations team members.
• Lead vendor selection, contracting, and management to maintain study quality and compliance.
• Oversee the performance and management of CROs and 3rd party vendors to ensure compliance.
• Ensure compliance with GCP/ICH guidelines and other regulatory requirements.
• Create and coordinate clinical study timelines and budgets.
• Identify, mitigate, and escalate risks throughout the study lifecycle.
• Co-develop and manage study materials, including protocols and operational plans.
• Oversee site selection, start-up, monitoring, and closeout for the trial.
• Provide regular updates on study progress to key stakeholders.
• Identify training needs for study team members and ensure training is carried out.

• 7 years of experience in clinical research, clinical operations, and clinical trial management.
• Experience in oncology studies and site management.
• Proficiency in vendor and CRO management.
• Experience in clinical study start-up and patient enrollment.
• Knowledge of GCP guidelines.

• Bachelor's degree in Science or equivalent.
• Experience leading Phase II or III global studies.
• Experience working with CROs and in global studies across multiple regions.
• Adaptability to a fast-paced environment.
• Excellent written and oral communication skills.
• Prior experience working as a CRA or in a Japanese company is a plus.

This is a 100% remote role, but candidates must be willing to work EST hours and be open to occasional face-to-face meetings.

Job Type & Location

This is a Contract to Hire position based out of Durham, NC.

The pay range for this position is $90.00 - $98.00/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 8, 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 : $90 - $98