Project Manager I - Study Start Up

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Summary:

The Project Manager is responsible for driving successful study start-up activities within our clinical research organization, focusing on all operational and logistical aspects leading up to site activation. This role centers on managing and coordinating the critical tasks required to prepare our clinical sites for study initiation. Key responsibilities include facilitating communication and collaboration among sponsors, clinical teams, and cross-departmental partners; coordinating site visits and meetings; tracking activation timelines and milestones; and ensuring compliance with regulatory and organizational standards. The ideal candidate will possess strong organizational and project management skills, exceptional attention to detail, and the ability to efficiently manage multiple moving parts in a fast-paced clinical research environment. Effective communication and coordination are essential to ensure seamless site readiness and timely study launch.

This position requires the candidate to be located in the Dallas-Fort Worth Metroplex

Qualifications:

• Bachelor's Degree and two years of relevant professional and/or research experience

• Master's degree preferred

• Experience in clinical research operations, preferably in study start-up or site activation.

• Knowledge of clinical trial processes and regulatory requirements including FDA, ICH GCP, and global regulatory requirements; experience preparing and reviewing IRB/EC submissions and essential documents.

• Proven project management or coordination experience including tracking timelines and milestones.

• Strong organizational skills with proven ability to manage multiple tasks concurrently.

• Excellent communication and interpersonal skills to collaborate with sponsors, clinical teams, and cross-department partners.

• Technical Proficiency: Familiarity with CTMS, EDC, and other clinical trial management or tracking software.

About Us:

Cook Children's Health Care System

Cook Children's Health Care System offers a unique approach to caring for children because we are one of the country's leading integrated pediatric health care delivery organizations. Patients benefit from the integrated system because it allows Cook Children's to use all of its resources to treat a patient and allows for easy communication between the various companies by physicians with a focus on caring for children and adolescents.

Cook Children’s is an equal opportunity employer. As such, Cook Children’s offers equal employment opportunities without regard to race, color, religion, sex, age, national origin, physical or mental disability, pregnancy, protected veteran status, genetic information, or any other protected class in accordance with applicable federal laws. These opportunities include terms, conditions and privileges of employment, including but not limited to hiring, job placement, training, compensation, discipline, advancement and termination.