Sr. Associate Clinical Project Manager

Job Description

Job Description

Job Title: Senior Associate Clinical Project Manager

Job Description

This role supports the management and execution of clinical studies under limited supervision, ensuring that all activities align with applicable domestic and international regulations, Clinical Investigation Plans, and Standard Operating Procedures. The Senior Associate Clinical Project Manager assists in developing effective clinical trial strategies, preliminary project timelines, and budgets to support successful product development and global marketing efforts. The position collaborates closely with clinical research monitors, clinical research associates, field clinical teams, and contract research organizations, while also providing clinical support to commercial functions. The role contributes to continuous improvement by helping to develop and refine procedures, systems, and training that promote regulatory compliance and operational excellence.

Responsibilities

• Coordinate key project deliverables, including team meetings, project budgets, timelines, and systems used to track study metrics.
• Assist Clinical Management with the development and planning of clinical study strategies, including study design, protocols, and other study-related documents and tools.
• Oversee and provide clinical input into the design of Case Report Forms and electronic databases to ensure they capture accurate and relevant study data.
• Assist with and coordinate the preparation of regulatory applications, amendments, responses to questions from authorities, supplements, reports, and advisory panel presentations required to conduct studies and obtain product approvals.
• Assist with and drive clinical site selection, activation, ongoing management, and close-out activities, ensuring completion of all necessary documentation throughout the study lifecycle.
• Prepare and deliver clinical presentations to physicians, clinical study staff, agents, and distributors as needed to support study understanding and engagement.
• Monitor or co-monitor clinical study sites to ensure adherence to the approved study protocol, plans, and objectives, including review of clinical monitoring reports when required.
• Ensure that clinical studies are adequately managed to meet protocol objectives, timelines, and quality expectations.
• Support Data Monitoring Committees or Data Safety Monitoring Boards and other committees or consultants established to support the studies, when applicable.
• Assist data management staff with clinical data review and collection from sites, including review of protocol deviations, adverse events, data inconsistencies, outliers, and other issues to maintain data integrity.
• Develop and execute a risk-based study management process and plan according to study-specific risk indicators and thresholds.
• Assist with the management of study vendors to ensure compliance with study plans, objectives, and vendor contracts, including task management of laboratories and contract research organizations when applicable.
• Help ensure sponsor and site compliance with relevant domestic and international government regulations and guidelines.
• Communicate effectively with study management, participating clinical sites, and vendors regarding issues, questions, and study updates.
• Create, update, and maintain site administrative files and trial master files, both electronic and paper, to ensure audit readiness at all times.
• Maintain accurate and up-to-date study tracking documents, such as enrollment logs, regulatory approvals and renewals, and payment trackers, as well as systems including clinical trial management systems.
• For premarket studies, instruct warehouse and field staff in clinical device distribution and recovery, and maintain a device accountability plan and reports.
• Coordinate and assist with data review, analysis, and preparation of clinical study reports, and manage the delivery of these reports.
• Coordinate site and study closeout activities and ensure proper archiving of study documents.
• Coordinate regulatory application amendments and support the timely submission of updates and changes.
• Support site activation activities, ensuring that all regulatory, contractual, and operational requirements are in place for study initiation.
• Support study closeout activities, including reconciliation of documentation, data, and investigational products.
• Work directly with clinical sites to foster strong relationships, address operational issues, and support successful study conduct.
• Track project deliverables and milestones, identifying potential risks or delays and supporting mitigation strategies.
• Assist with overall project execution, contributing to planning, problem-solving, and continuous improvement throughout the project.

Essential Skills

• Bachelors degree and at least 4 years of relevant clinical research or clinical project management experience.
• Demonstrated experience in clinical project management and clinical trial execution.
• Experience with project oversight, including managing timelines, deliverables, and study performance.
• Proven ability to track and manage study timelines and milestones.
• Experience in site management, including site selection, activation, oversight, and closeout.
• Experience working in a cross-functional environment, coordinating with internal and external stakeholders.
• Strong ownership mindset with the ability to take initiative and drive tasks to completion.
• Excellent verbal and written communication skills, with the ability to interact effectively with clinical sites, internal teams, and external partners.
• Ability to manage multiple priorities and projects simultaneously in a dynamic environment.
• Comfort working under limited supervision while maintaining high standards of quality and compliance.
• Strong organizational skills with attention to detail in documentation, tracking, and reporting.
• Proactive and curious approach, with comfort in asking questions and seeking clarification when needed.
• Approachable and collaborative working style that supports effective teamwork.

Additional Skills & Qualifications

• Medical device clinical research experience is strongly preferred.
• Experience in drug development is acceptable and considered relevant.
• Previous experience in the pharmaceutical or contract research organization industry is also acceptable.
• Experience coordinating or supporting risk-based study management processes is beneficial.
• Experience working with Data Monitoring Committees or Data Safety Monitoring Boards is an advantage.
• Familiarity with Case Report Form design and electronic data capture systems is valuable.
• Experience using clinical trial management systems and maintaining trial master files is preferred.
• Prior experience progressing from a Clinical Project Coordinator or similar role into project management responsibilities is advantageous.
• Ability to travel occasionally for qualification visits and other study-related activities.
• Ability to travel to the companys headquarters in Houston approximately 45 times per year.

This is a Contract position based out of Houston, TX.

The pay range for this position is $55.00 - $55.00/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)

This is a Contract position based out of Houston, TX.

This position is anticipated to close on Oct 23, 2026.

This is a fully remote position.

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 View email address on ziprecruiter.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.