Project Manager
2 weeks ago
Job Functions, Duties, Responsibilities and Position Qualifications:
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Position Summary:
The Clinical Trials - Central Laboratory ?Project Manager (PM) is responsible for planning and implementation of project set up and ongoing protocol management supporting central laboratory services for Phase I to Phase III clinical trials. The PM understands, supports, and prepares appropriate material and systems touching all operational aspects of laboratory delivery. The PM is responsible for timely communication with all levels of internal and external organizational personnel. The PM liaises with pharma sponsors, clinical research organizations, and principal investigators and demonstrates a broad understanding of clinical trials life cycle as it relates to the central laboratory role.
Location:
Austin, TX 78728 (100% onsite)
Duties & Responsibilities:
- Review protocols and amendments to ensure alignment with client requirements and study objectives.
- Collaborate with sponsors to define scope, goals, and deliverables; develop project plans and communication tools.
- Coordinate study setup, including database readiness, supply distribution, and internal stakeholder alignment.
- Monitor study progress, manage budgets, and communicate updates, risks, and mitigation strategies to stakeholders.
- Lead protocol compliance efforts, including site communication, training, and documentation.
- Oversee data integrity, including database maintenance, data handling, and reporting.
- Support study start-up activities, including investigator outreach, site readiness, and quality checks.
- Prepare and present training materials for investigator meetings and site sessions.
- Assist with data transfers, invoicing, and resolution of study holds or alerts.
- Participate in client audits and maintain GCP and IATA awareness.
- Contribute to team training and support SRLs industry engagement initiatives.
Education and Experience:
Education:
- Bachelors degree in a biological science (BS/BA)
Experience:
- Minimum 3 years experience in Project Manager central lab role
- Previous experience in clinical trial laboratory setting or equivalent.
- Superior Customer service skills.
- Strong Microsoft Office application skills.
- Good problem solving and troubleshooting skills.
Knowledge, Skills, and Abilities:
- Thorough knowledge of the requirements of a clinical lab and clinical trials environment
- Experience in clinical trial management databases and LIMS
- Thorough understanding of the drug development process.
- Demonstrated ability to effectively engage and communicate with clients.
Scheduled Weekly Hours:
40Work Shift:
Job Category:
Laboratory OperationsCompany:
Sonic Reference Laboratory, IncSonic Healthcare USA is an equal opportunity employer that celebrates diversity and is committed to an inclusive workplace for all employees. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, age, national origin, disability, genetics, veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.
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