Clinical Trial Manager – Contract to Hire

Job not on LinkedIn

🔥 5 minutes ago

🗽 New York – Remote

🗽 New York – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧪 Clinical Research

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TransPerfect

WebsiteLinkedInAll Job Openings

5001 - 10000 employees

💼 Consulting

⚖️ Legal

📣 Marketing

Consulting • Legal • Marketing

TransPerfect is a global language and technology company that provides translation, localization, interpretation, and content services combined with software and AI-powered tools such as the GlobalLink translation management platform. It offers multilingual marketing, legal and life‑sciences regulatory support, contact center/BPO services, multimedia localization, and solutions for website, software and app globalization. TransPerfect serves large enterprise and Fortune 500 clients across dozens of industries and supports content in 200+ languages.

📋 Description

• Evaluate new studies with the Principal Investigator and assess protocol feasibility, patient population, staffing, equipment, and space • Complete Sponsor and CRO feasibility questionnaires and participate in pre-study and site qualification visits • Prepare and submit IRB applications, informed consent forms, amendments, continuing reviews, and safety reports • Coordinate review of Clinical Trial Agreements and Confidentiality Agreements with clinic leadership and legal counsel • Develop and negotiate study budgets with Sponsors • Lead site initiation visits and activate sites after approvals, training, and supplies are complete • Oversee day-to-day conduct of active studies and ensure compliance with protocols, GCP, FDA regulations, HIPAA, and clinic policies • Oversee participant recruitment, screening, consent, enrollment, scheduling, and retention • Ensure accurate and timely source documentation and EDC data entry; oversee query resolution • Ensure adverse events, serious adverse events, and protocol deviations are documented and reported on time • Oversee investigational product accountability, including receipt, storage, dispensing, temperature monitoring, and return or destruction • Oversee specimen collection, processing, storage, and shipment, including staff shipping training • Serve as primary contact for Sponsors, CROs, and monitors; host monitoring visits and resolve findings • Maintain inspection-ready regulatory binders and electronic study files • Ensure research staff maintain current GCP, human subjects protection, and protocol-specific training • Maintain and update research SOPs, templates, and work instructions • Prepare for Sponsor audits and FDA or other regulatory inspections • Lead development and tracking of corrective and preventive actions (CAPAs) • Ensure applicable studies are registered and updated on ClinicalTrials.gov • Track study budgets, invoiceable items, Sponsor payments, invoicing, and reconciliation • Support research billing compliance by separating routine-care charges from research-related charges • Prepare enrollment, financial, and performance reports for the PI and clinic leadership • Manage study supplies, equipment calibration and maintenance records, and vendor relationships • Hire, train, schedule, supervise, and evaluate Clinical Research Coordinators and other research staff • Allocate workload across studies and monitor staff capacity • Foster collaboration between research staff and clinical staff • Recommend improvements to research processes, recruitment, and efficiency • Perform other duties supporting the clinic's research program

🎯 Requirements

• Bachelor's degree in life sciences, nursing, healthcare, or a related field, or an equivalent combination of education and relevant experience • At least 5 years of clinical research experience, including at least 2 years coordinating studies at a clinical research site • At least 1 year of experience supervising or leading research staff; equivalent informal leadership experience is acceptable • Working knowledge of GCP, ICH guidelines, FDA regulations (21 CFR Parts 50, 54, 56, and 312/812), and HIPAA • Experience with IRB submissions, informed consent processes, and regulatory documentation • Strong organizational skills and ability to manage multiple studies, deadlines, and priorities simultaneously • Excellent written and verbal communication skills with Sponsors, monitors, patients, and clinical staff • Proficiency with Microsoft Office • Comfort learning EDC, CTMS, eRegulatory, and EHR systems • Current ACRP (CCRC, CCRP) or SOCRA (CCRP) certification preferred • Experience with study budgeting, contract review, and Sponsor negotiations preferred • Experience with clinical research billing compliance and Medicare coverage analysis preferred • Experience in the clinic's therapeutic areas preferred • Rare disease or pediatric studies are a plus • Clinical skills such as phlebotomy, vital signs, or ECG, as permitted by licensure and scope of practice preferred • Experience with FDA inspections or Sponsor audits preferred • Ability to travel to Midwest clinical sites, especially during study startup

🏖️ Benefits

• 12-month contract-to-hire arrangement • Remote work for US-based candidates • Periodic site visits rather than a specific home location requirement

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