Support the Company's clinical trial activities
Manage day to day operations of one or more phase 1-3 clinical trials including trial start up, conduct and close out activities
Serve as the primary contact for managing protocol execution, including oversight of the CRO, study service providers, and consultants
Lead cross-functional study execution team
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
Ensure that the Trial Master File (TMF) is set up and maintained appropriately
Participate and coordinate resolution of audit finding and ensures audit-ready condition of clinical trial documentation
Manage clinical trial budgets, providing ongoing financial reporting and projections
Perform and manage data review process on an ongoing basis
Perform site visits as needed.

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 regulatory frameworks 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 communication skills to effectively disseminate information to project team and outside parties
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
Flexible work arrangements
Professional development opportunities

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 processfinancial reportingbudget managementaudit resolutionclinical trial documentationTrial Master File (TMF) managementregulatory compliance

Soft Skills

communication skillsleadershipcross-functional team managementorganizational skillsproblem-solving