Senior Clinical Study Manager

Location: Bala Cynwyd

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,…