Senior Clinical Trial Manager

ACTalent; United States; Hybrid; USD 138.000 - 172.000; Vollzeit

Benefits dieser Stelle

Medical benefits

Dental benefits

Vision benefits

401(k) plan

Life Insurance

Disability insurance

Health Spending Account

Transportation benefits

PTO & Vacation

Zusammenfassung

Actalent is hiring a Sr Clinical Trial Manager in the United States to lead planning, start-up, execution and close-out of global trials, with emphasis on rare and ultra-rare disease programs. You will coordinate CROs, vendors, and study sites to ensure compliance with ICH-GCP and regulatory standards, while driving on-time, on-budget delivery.

The role requires a track record of 10+ years in clinical operations, hands-on management of global Phase III/IV trials, and strong cross-functional

Qualifikationen

• 10+ years of clinical operations experience.
• Experience leading global Phase III/IV trials.
• Experience in rare or ultra-rare disease programs.
• Strong knowledge of GCP/ICH and regulatory requirements.
• Ability to manage CROs and vendors.

Aufgaben

• Lead planning, initiation, execution, and close-out of global trials.
• Coordinate CROs, vendors, and sites to ensure compliance.
• Track timelines, enrollment targets, budgets, milestones.
• Develop and maintain core study documents; manage risk.
• Drive cross-functional communication and process improvements.

Kenntnisse

Ten years clinical ops

Phase III/IV trials

Rare/ultra-rare disease

GCP/ICH regulatory

CRO/vendor management

Cross-functional collaboration

Risk management

Operational planning

Communication skills

Independent worker

Ausbildung

Bachelor's in life sciences

Advanced degree preferred

Tools

CTMS

EDC

Jobbeschreibung

Job Title: Sr Clinical Trial Manager

Job Description

The Sr Clinical Trial Manager leads the planning, start-up, execution, and close-out of global clinical trials, with a strong focus on rare and ultra-rare disease programs. This role serves as the primary operational contact for contract research organizations (CROs), vendors, and study sites, ensuring that all study activities adhere to protocols, standard operating procedures, ICH-GCP guidelines, and regulatory requirements. The position requires a seasoned clinical operations professional who can drive complex Phase IIII trials, proactively manage risk, and collaborate across functions to deliver high-quality results on time and within budget.

Responsibilities

• Lead the planning, initiation, execution, and close-out of global clinical trials, ensuring operational excellence at every stage.
• Serve as the primary operational contact for CROs, external vendors, and investigational sites, fostering strong, collaborative relationships.
• Ensure all study activities comply with study protocols, SOPs, ICH-GCP guidelines, and applicable regulatory requirements.
• Track and manage study timelines, enrollment targets, budgets, and key milestones, proactively identifying and mitigating risks to study delivery.
• Support the development, review, and maintenance of core study documents, including protocols, Investigators Brochures (IBs), informed consent forms (ICFs), site tools, and operational plans.
• Coordinate cross-functional communication among clinical, regulatory, data management, and other stakeholders to maintain alignment and efficient study execution.
• Plan and conduct regular study team meetings, providing clear status updates and risk assessments to internal leadership.
• Oversee vendor performance, monitor deliverables, and ensure contractual obligations and quality standards are consistently met.
• Collaborate with clinical operations leadership to identify, recommend, and implement process improvements that enhance efficiency and quality.
• Troubleshoot operational issues as they arise, developing solutions and escalating concerns when necessary to maintain study continuity.
• Drive both strategic planning and hands-on tactical execution, demonstrating a willingness to engage in detailed operational tasks as needed.

Essential Skills

• Minimum of 10 years of clinical operations experience, including at least 3+ years in a Clinical Trial Manager or similar role.
• Proven experience managing global Phase IIII clinical trials in clinical research, pharmaceuticals, or biotechnology settings.
• Experience working on rare or ultra-rare disease clinical programs, with rare neurodegenerative disease experience strongly preferred.
• Strong understanding of Good Clinical Practice (GCP), ICH guidelines, and relevant regulatory requirements governing clinical trials.
• Demonstrated ability to oversee CROs and vendors, including performance management and deliverable oversight.
• Deep knowledge of clinical trial processes, from start-up through close-out, including site activation, enrollment, monitoring, and data lock.
• Excellent written and verbal communication skills, with the ability to present clear updates and influence cross-functional stakeholders.
• Strong organizational skills, with the ability to manage multiple complex studies, timelines, and competing priorities.
• Advanced problem-solving skills, with a proactive approach to risk identification and mitigation.
• Ability to work independently, take initiative, and drive study execution with minimal supervision.
• A hands-on, roll-up-your-sleeves mindset and comfort handling both strategic and operational tasks.

Additional Skills & Qualifications

• Bachelors degree in life sciences or a related field is required; an advanced degree is a plus.
• Experience with global rare disease clinical trials, ideally in neurology, is highly desirable.
• Exp in clinical research within pharmaceuticals or biotech environments.
• Proven success collaborating with cross-functional teams, including clinical, regulatory, data management, and biostatistics.
• Strong interpersonal skills and the ability to build effective relationships with internal teams, CROs, vendors, and study sites.

Work Environment

This position is based in a local office environment with an expectation to work onsite approximately three to four times per week. The role involves regular interaction with cross-functional colleagues, CROs, and external vendors, supported by standard clinical trial technologies and communication tools. The work setting is professional and collaborative, with a focus on delivering high-quality global studies in rare and ultra-rare diseases.

Job Type & Location

This is a Contract position based out of South San Francisco, CA.

Pay and Benefits

The pay range for this position is $100.00 - $125.00/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)

Application Deadline

This position is anticipated to close on Nov 14, 2026.

Workplace Type

This is a hybrid position in South San Francisco, CA.

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 [e-mail] 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.