Clinical Study Manager

Actalent; United States; Hybrid; USD 96,000 - 117,000; Full time

Benefits offered by this job

Medical, dental & vision

401(k) Retirement Plan

Life Insurance

Time Off / PTO

Job summary

Actalent is seeking a Clinical Study Manager to oversee end-to-end clinical trial activities (Phases 1–4) and ensure compliance with GCP/ICH guidelines. This hybrid role in Bala Cynwyd, PA, involves leading cross-functional teams, managing external partners, and contributing to regulatory submissions while maintaining data integrity.

The role requires 3–5 years in pharmaceutical clinical trial management, strong vendor oversight, and budget management.

Qualifications

• Bachelor’s degree required in a scientific or healthcare field.
• 3–5 years of clinical trial management experience in pharma.
• Experience with phase 1–4 trials and CRO oversight.
• Strong knowledge of GCP, ICH, and regulatory guidelines.

Responsibilities

• Write and review protocols, amendments, and informed consent forms.
• Ensure regulatory compliance and support IND submissions.
• Oversee CROs, CRAs, and vendors to deliver on time.
• Lead cross-functional study teams and manage budgets.
• Monitor data integrity and use EDC systems.

Skills

Clinical trial management

Vendor management

Budget management

GCP/ICH knowledge

EDC systems

Cross-functional leadership

Regulatory submissions

Education

Bachelor’s degree

Tools

MS Office

EDC systems

Job description

The Clinical Study Manager oversees end-to-end clinical trial activities across phases 1 through 4, ensuring high-quality execution, regulatory compliance, and alignment with overall clinical and regulatory strategy. This role involves leading cross-functional teams, managing external partners, and contributing to key regulatory submissions while maintaining data integrity and adherence to GCP/ICH guidelines.

Responsibilities

• Write, review, and refine clinical study protocols and related documents, including amendments, informed consent forms, and operational plans.
• Ensure regulatory compliance for phase 1–4 clinical trial activities, aligning all study processes with applicable regulations and guidelines.
• Contribute to the development of Investigational New Drug (IND) applications and other regulatory submissions by providing clinical operations input and documentation.
• Oversee contract research organizations (CROs), clinical research associates (CRAs), and third-party vendors to ensure delivery of high-quality work on time and within scope.
• Participate in CRO selection, including evaluation of proposals, capabilities, and performance metrics.
• Develop, manage, and track clinical study budgets, including forecasting, cost control, and variance analysis.
• Collaborate with internal and external teams to ensure clinical projects align with overall program and company strategy.
• Review and approve clinical study documents, including monitoring plans, site manuals, and other trial-related materials, to ensure consistency and quality.
• Ensure data integrity and compliance with Good Clinical Practice (GCP), International Council for Harmonisation (ICH) guidelines, and internal standard operating procedures (SOPs).
• Oversee site management activities, including site start-up, monitoring, and close-out, to ensure adherence to protocol and timelines.
• Coordinate and support clinical trial operations, including patient enrollment, data collection, and safety reporting.
• Provide leadership to cross-functional study teams, fostering effective communication and collaboration among clinical, regulatory, data management, and other stakeholders.
• Monitor vendor performance, identify issues or risks, and implement corrective and preventive actions as needed.
• Utilize electronic data capture (EDC) systems and other clinical trial technologies to support efficient study conduct and data management.
• Maintain strong relationships with study sites and principal investigators, serving as a key point of contact for operational and procedural questions.

Essential Skills

• 3–5 years of experience in the pharmaceutical industry and clinical trial management.
• Proven clinical project management experience, including planning, execution, and oversight of phase 1–4 clinical studies.
• Demonstrated experience in vendor management, including oversight of CROs, CRAs, and third-party vendors.
• including site management, monitoring oversight, and adherence to SOPs.
• Hands-on experience with clinical trial management and clinical development activities.
• Proficiency in budget development and budget management for clinical studies.
• Solid understanding and practical application of Good Clinical Practice (GCP) and ICH guidelines.
• Experience with electronic data capture (EDC) and other clinical trial systems.
• Bachelor’s degree required.
• Proficiency in MS Office and other relevant software tools.
• Strong interpersonal skills with the ability to create and maintain productive relationships with study sites and principal investigators.
• Ability to lead and collaborate with cross-functional teams in a fast-paced clinical development environment.

Additional Skills & Qualifications

• Knowledge of neurological or rare disease drug development, particularly in ataxia, is preferred but not mandatory.
• Experience contributing to IND development and other regulatory submissions.
• Familiarity with regulatory requirements for early- and late-phase clinical trials.
• Experience reviewing and approving clinical study documents and operational plans.

Work Environment

This role follows a hybrid model with one day on-site per week in an office located in Pennsylvania, with the option for additional on-site days as needed.

Job Type & Location

This is a Contract position based out of Bala Cynwyd, PA.

Pay and Benefits

The pay range for this position is $70.00 - $85.00/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 jobclassification and length of employment. Benefits are subject to change and may besubject to specific elections, plan, or program terms. If eligible, the benefitsavailable 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)

Workplace Type

This is a hybrid position in Bala Cynwyd,PA.

Application Deadline

This position is anticipated to close on Sep 18, 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 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 withoutregard to race, sex, age, color, religion, national origin, veteran status, disability,sexual orientation, gender identity, genetic information or any characteristic protectedby law.

If you would like to request a reasonable accommodation, such as the modification oradjustment of the job application process or interviewing process due to a disability,please email [e-mail] for other accommodation options.

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

It is unlawful in Massachusetts to require or administer a lie detector test as acondition of employment or continued employment. An employer who violates this lawshall be subject to criminal penalties and civil liability.

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