Manhattan WMOS Engineer
ShyftLabs
Support Manhattan WMOS implementations and operations as a WMS Engineer at ShyftLabs. ShyftLabs builds data products and digital solutions for Fortune 500 companies.
Open
Parexel is a global clinical research organization serving biopharmaceutical companies throughout the development of new medicines. Its work spans Phase I–IV clinical trials, portfolio and trial management, regulatory strategy, market access, and lifecycle planning. With more than 21,000 professionals, Parexel combines clinical, regulatory, and therapeutic expertise with patient insights and innovative trial designs. The company supports research across areas including oncology, neuroscience, and rare diseases, with a focus on making clinical development more efficient and patient-centered.
Senior Clinical Research Associate, Central or Western US
Oversee investigator sites and clinical trial monitoring for Parexel across the Central or Western United States. Support patient safety, GCP compliance, recruitment, and study quality throughout the trial lifecycle.
Description
- Oversee management, monitoring, and close-out of assigned clinical trial investigator sites.
- Protect patient safety and ensure high-quality study conduct in line with applicable laws, GCP, and sponsor standards.
- Manage investigator relationships and trial operations from site activation through database lock.
- Act as the primary contact for assigned investigator sites.
- Coordinate with Site Care Partners, study teams, vendors, and investigator sites.
- Support site development through coaching, training, and protocol guidance.
- Monitor sites onsite and remotely or electronically during initiation, routine follow-up, and closure.
- Track adverse events and serious adverse events in collaboration with the Drug Safety Unit.
- Submit TMF documents, site reports, follow-up letters, protocol deviations, recruitment updates, and study progress reports.
- Identify and address site issues, developing corrective and preventive actions as needed.
- Resolve data queries and carry out investigator site close-out activities.
- Oversee investigational product receipt, handling, accountability, storage, and destruction.
- Support database release and, where needed, conduct unblinded monitoring.
- Maintain knowledge of products, protocols, and relevant therapy areas.
- Support patient safety, eligibility assessments, and clinical guidance.
- Lead quality-event remediation and audit CAPA activities.
Requirements
- Strong knowledge of clinical trial methods, ICH/GCP, FDA requirements, and local regulations.
- At least two years of relevant experience monitoring clinical research sites.
- Fluency in English and the native language or languages of the country of employment.
- Ability to travel 60–80% of the time.
- Valid driver's license and passport.
- Bachelor's degree in life sciences or an equivalent professional life sciences qualification, such as nursing, pharmacy, or medicine.
Benefits
- Parexel is an equal opportunity employer.
- Contribute to therapies that benefit patients and advance global health.
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