Clinical Trial Manager

A small biopharma company is looking to add two Clinical Trial Managers to their team. In this role you will help to the Head of Clinical Operations (HCC) and will be responsible for supporting recruitment, initiation, conduct (day to day operations) and close-out of clinical trials and assist in the management and day to day operations of the CRA field staff.

Qualifications :

RN, RT or bachelor’s degree in a science-related field or equivalent job experience.

5 years’ experience in the clinical trials field or a related field, 8+ years of industry experience.

• Would love to see those coming from a clinical background (RN, PA, etc.) with CRA experience, advantageous for field understanding and medical terminology familiarity.
• Prior experience supporting P2B & Ph3 studies - must have launch experience
• Prior experience working for both sponsor and CRO (3 / 2 split)
• Prior experience supporting blinded and unblinded Phase 2 & 3 studies.

Main focus will be on blinded study

Therapeutics area : neonatal care, respiratory, intensive care, and oncology experience, ideally with intensive study involvement (not from asthma or allergy backgrounds).

Focus on drug over device for this drug / device combination.

Understanding and use of multiple EDC platforms

Available to travel up to 25%

• international & domestic (must have a valid driver’s license and passport)
• Able to work onsite 3 days / week in Raleigh, NC or San Mateo, CA, strong preference for NC (new office opening in Q1 2025, fully remote until then).

Preferred skills : Clinical supply chain management experience, given the complexities of drug and device product logistics.

Prior experience working in a startup environment

Duties / Responsibilities :

• Coordinating & tracking monitoring visits for the field clinical monitoring team
• Tracking and coordinating team project-specific and SOP training for the field CRA staff.
• Reviewing, tracking, and finalizing monitoring visit trip reports and follow-up letters
• Coordinating the trial start-up efforts and management of the regulatory documents to ensure sitAssoe readiness for SIVs
• Managing the eTMF
• Managing clinical supplies in conjunction with the unblinded CRA.
• Creating and implementing study-specific plans (clinical monitoring plan), clinical monitoring tools and documents.
• Assuring compliance with SOPs, local regulations, and CFR, ICH / GCP guidelines.
• Participation in initial creation of screening, data collection forms, and database / data entry screens.
• Support site specific development of IRB submission packages or Pharma central IRB submissions.
• Field / Remote Monitoring / Co-monitoring as needed.
• Participation in site qualification, site initiation visits, interim monitoring visits an close-out visits as necessary.
• Perform field evaluation of monitors at pre-determined intervals or as needed.
• Oversight of study progress and day to day operations with sites (PIs, Coordinators, & other research staff).
10 hours ago