Job Description

Location: Morristown, NJ/Hybrid

Base Salary up to $150k plus bonus and LTI.

Our biopharmaceutical client located in Northern NJ area has tasked Scientific Search with finding a Clinical Trial Manager. This role is responsible for supporting study management activities for clinical studies in compliance with Standard Operating Procedures (SOPs), ICH-GCP, clinical study protocol and all applicable regulatory requirements.

Responsibilities

• Ensures that study conduct is in accordance with the study protocol, Good Clinical Practices, and Standard Operating Procedures, and regulatory authorities, as applicable
• Manages all day-to-day communications and tasks with internal team, vendors and investigational sites. Oversees site start-up, subject recruitment, enrolment, study management, monitoring, site management, trial master file, and data clean up
• Attends, contributes and may lead cross-functional team meetings, Investigator Meeting, conferences and events
• Review and contributes to protocol development, Informed Consent Form, eCase Report Forms, and any additional study documents for study conduct
• Participate in vendor selection, assists with review of contracts and negotiation of study budgets. Also participate in review of site budget and contracts.
• Conducts site management (e.g. device accountability, Investigator credentialing, and research staff training) including Sponsor Oversight Visits. Review monitoring reports.
• Participate in the preparation and follow-up/resolution of regulatory authority inspections as well as internal audits, site audits and other quality audits.
• Assists and/or manage activities and interactions with contractors, CROs, and/or vendors
• May perform on-site monitoring, audit and verify data entered on eCRFs are complete accurate and consistent with source data. Generate MVRs after each visit.
• Maintains all relevant documentation and communications as part of study files including review of TMF for completeness
• Review and contribute to CSR development

Requirements

• Bachelor’s degree or equivalent required in science/health preferred
• Minimum 5+ years clinical operations/study management experience including site monitoring (knowledge of audit preparation and sponsor oversight monitoring a plus)
• Experience in managing CROs and other vendors
• Experience in clinical trial electronic systems such as eDC,TMF and CTMS
• Working knowledge of ICH GCP guidelines and essential documents and TMF

How To Apply: We’d love to see your resume, but we don’t need it to have a conversation. Send us an email to tom@scientificsearch.com and tell me why you’re interested. Or, feel free to email your resume.

Job Tags

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