5-7 years of experience in clinical research project management
Strong understanding of clinical research protocols and regulatory processes
Familiarity with FDA IND, DSMB, and IRB submissions
Experience with Investigator Initiated Trials (IITs) preferred
Excellent communication and organizational skills
Responsibilities
Provide project management support for investigator-initiated clinical research studies
Write and prepare protocols and regulatory submissions accurately and timely
Review study data and collaborate with teams to ensure data quality
Maintain regulatory files and ensure documentation meets research requirements
Manage assignments and adjust priorities based on study needs
Benefits
Group Medical, Dental, Vision, and Life Insurance
Retirement Savings Program
Remote work flexibility
40 hours per week
3-month assignment
Full Job Description
Job Description
Hourly pay: $60/hr
Worksite: Leading medical institution (Remote, Open to candidates in the United States - Remote)
W2 Employment, Group Medical, Dental, Vision, Life, Retirement Savings Program
40 hours/week, 3 Month Assignment
A leading medical institution is seeking a Sr. Project Manager to provide project management support and oversight for investigator-initiated clinical trials within a hematology/oncology clinical research team.
Sr. Project Manager Responsibilities:
Provide project management support and oversight for assigned investigator-initiated clinical research studies, working under the direction of investigators and clinical research unit leadership, and serve as the primary point of contact for investigators, regulatory and study coordinators, data managers, research staff, and study monitors.
Write protocols and study documents accurately and on time, and help prepare and complete FDA IND, DSMB, IRB, and other regulatory submissions.
Review and follow up on study data and monitoring findings, collaborating with study teams and study monitors to support data quality.
Maintain regulatory files and ensure study documentation is complete, accurate, and current to meet research requirements and established study timelines.
Manage assignments from the team director and study investigators, adjusting priorities based on study and departmental needs, and make sure study and patient care needs are addressed appropriately and on time.
Sr. Project Manager Qualifications:
Experience or demonstrated ability in clinical research project management.
Knowledge of clinical research protocols, study documentation, and regulatory processes, including FDA IND, DSMB, and IRB submissions.
Experience with Investigator Initiated Trials (IITs) is preferred.
