Clinical Trial Manager

Clinical Study Manager

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.
• 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 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)

Workplace Type

This is a hybrid position in Bala Cynwyd, PA.

Application Deadline

This position is anticipated to close on Sep 28, 2026.