Clinical Trial Project Manager Jobs in Pennsylvania

Maintaining a working knowledge of current FDA regulations, ICH-GCP guidelines, all relevant guidance documents, and assigned study protocol(s).

Working with third party consultants as needed to manage related regulatory submissions and/or communications with the FDA.

Minimum of 5 years experience in Clinical Research

Diagnostics-related clinical study experience preferred

Experience with FDA communications/submissions, including Q-subs, 510k, and/or de novo submissions preferred.

ACRP or equivalent certification is preferred

Minimum 3 years of CAR-T experience

Strong oral and written communication skills with ability to work with cross-functional teams

Formulate and execute operational strategies to achieve successful in-house implementation and oversight of clinical trials focused on CAR-T

Oversee all aspects of trial initiation procedures, working in coordination with other departments within Clinical Operations

Uphold adherence to regulatory requisites, encompassing ICH-GCP, FDA directives, and other pertinent regulations throughout every phase of the trial's lifecycle

A BA/BS in science related field

Lead role in vendor identification/qualification/selection, systems set-up/management including EDC, IWRS, Central Laboratories, specialty services (ePRO, eDiary, etc.)

Demonstrated experience in management of CROs, in vendor selection

Required Education, Skills, And Knowledge

Risk management and mitigation including prioritization of competing tasks and issues to ensure program/study objectives are successfully accomplished.

Ability to critically review and supervise a multifunctional vendor groups including clinical operations, data management and biometrics

Effectively tracks and communicate program/study progress to Senior Management with ability to create and update detailed dashboards and trackers