Serve as the primary contact for managing protocol execution, including oversight of the CRO, other study service providers, and consultants that are involved in a clinical trial
Lead cross-functional study execution team in support of study deliverables
Support establishment of study milestones and ensure accurate tracking and reporting of study metrics and timelines to leadership
Ensure clinical trials are managed and executed in accordance with ICH GCP, regulations, the protocol, and company-specific SOPs
Assist in preparation and review of clinical trial documentation such as; protocol, informed consent, Investigator Brochure, Clinical Monitoring Plan, Project Plan, Case Report Forms, Statistical Analysis Plan, Clinical Study Reports, and other study level documents
Ensure that the Trial Master File (TMF) is set up and maintained appropriately throughout the trial, including periodic reviews
Participate and coordinate resolution of audit finding and ensures audit-ready condition of clinical trial documentation including central clinical files
Negotiate and finalize site contracts and budgets
Manage clinical trial budgets, providing ongoing financial reporting and projections
Perform and manage data review process on an ongoing basis
Perform site visits including site qualification, initiation, monitoring and close-out visits, as needed
Oversee outsourced monitoring by reviewing, monitoring reports to ensure quality and resolution of site-related issues.

Requirements

B.A./B.S. degree
6+ years of clinical research experience within the Biotech or similar industry, with at least 2 years directly supporting clinical trial management
Knowledge of GCP, ICH guidelines and regulatory requirements for clinical trial management; Strong clinical study management skills
Understanding of, and experience with, regulatory framework applicable to interactions with HCPs, payers, advocacy and other business partners
Proven clinical operational skills to direct protocol execution to ensure timeline, budget and quality metrics are met
Excellent organizational, conflict resolution, prioritization and negotiation skills
Team oriented and ability to effectively collaborate with study team, cross-functional team members, and external partners
Proficient computer skills, specifically with Microsoft Office Suite that include Word, Excel, PowerPoint, and Outlook
Working knowledge of MS Project for development and update of clinical study timelines.

Benefits

Health insurance
401(k) matching
Flexible work hours
Paid time off
Remote work options

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

clinical trial managementprotocol executionclinical study managementdata review processbudget managementaudit resolutionclinical documentation preparationsite qualificationmonitoringnegotiation

Soft Skills

organizational skillsconflict resolutionprioritizationnegotiation skillsteam orientedcollaboration