Note: The job is a remote job and is open to candidates in USA. Software Guidance & Assistance, Inc. (SGA) is recruiting for a healthcare client. The Senior Project Manager will provide project management support and oversight for investigator-initiated clinical research studies, coordinating with investigators and multidisciplinary research teams and supporting study documentation, regulatory submissions, and data quality.
Responsibilities
- Serve as the primary point of contact for investigators, regulatory coordinators, study coordinators, data managers, research staff, and study monitors
- Provide project management support and oversight for assigned investigator-initiated clinical research studies
- Ensure accurate and timely writing of protocols and study documents
- Assist with the preparation and completion of FDA IND, DSMB, IRB, and other regulatory submissions
- Review and follow up on study data and monitoring findings
- Assist with maintaining regulatory files to fulfill research requirements and meet established study timelines
- Collaborate with study teams and study monitors to support data quality
- Ensure study documentation is complete, accurate, and maintained in a timely manner
- Manage assignments from the team Director and study investigators, adjusting priorities based on study and departmental needs
- Ensure studies and patient care needs are addressed appropriately and in a timely manner
Skills
- Experience or demonstrated ability in clinical research project management, preferably involving Investigator Initiated Trials (IITs)
- Knowledge of clinical research protocols, study documentation, and regulatory processes
- Familiarity with FDA IND, DSMB, IRB, and other regulatory submissions
- Ability to review study data, address monitoring findings, and maintain accurate regulatory documentation
- Strong organizational and time management skills, with the ability to meet established study timelines
- Ability to work independently and collaboratively with multidisciplinary research teams
- Strong written communication skills, particularly in protocol and study document preparation
- Excellent interpersonal and communication skills to coordinate with investigators, research staff, and study monitors
- Ability to manage multiple assignments and adjust priorities based on changing study and departmental needs
- Strong attention to detail and commitment to maintaining data quality and documentation accuracy
Benefits
- Remote work (PST hours).
Company Overview
Company H1B Sponsorship