JOB DESCRIPTION:

Purpose and Scope

The Clinical Trial Manager (CTM) is an integral member of the Clinical team. The CTM is responsible for the strategic planning, operational execution, and management of company-sponsored clinical trials for medical devices. The CTM oversees all facets of one or more clinical studies from site selection, startup, and patient enrollment through to data cleaning, database lock, and final reporting. This role makes certain that all studies are conducted in compliance with protocols, Standard Operating Procedures (SOPs), and regulatory guidelines to ensure the integrity of all clinical data. This position requires detail-orientation, organization, and a strong desire to learn clinical research processes continuously.

Responsibilities

• Assists in the preparation of protocols, CRFs/EDC, Investigator Site Files, Brochures, and Study Manuals.
• Maintain compliant trial master files of the clinical trial and ensure each site is maintaining its Investigator Site Files as required.
• Ensure each site is meeting its goals of enrollment, follow-up rate, data clean deadlines and protocol compliance.
• Conduct qualification, onsite initiation, regulator interim, and close-out monitoring visits, as needed.
• Support sites as needed for essential document reviews, IRB/EC submissions, etc.
• Perform internal audits or site audits as requested by Clinical Affairs Management.
• Performs trial training of investigators and study coordinators as needed.
• Ensure timely completion of clinical reports, including monitoring visit reports.
• Support the Clinical team and participate in project management of trial and various improvement projects.
• Recognize potential obstacles (both at Moximed and sites) and work to resolve them within set timelines.
• Monitor emerging industry and regulatory trends to help integrate new requirements into department procedures (i.e., action items, protocol deviations, adverse events, diversity, etc.).
• Complete projects and tasks consistent with corporate objectives.
• Attend relevant symposia, meetings, and conferences as needed.
• Support safety monitoring and processes as needed.
• Participate in department systems and development initiatives including related training (i.e., Electronic Data Capture, Clinical Trial Management System, Trial Master File, etc.).
• Perform other duties as assigned by Clinical Affairs Management.
• Contribute to the Company culture of being collaborative, respectful, transparent, ethical, efficient, high-achieving, and fun!

JOB REQUIREMENTS:

Education and Training

• Bachelor’s degree in a scientific or health-related field.
• Minimum 5 years of clinical trial management experience, with at least 3+ years of specific medical device experience (orthopedics preferred).
• Clinical Trial monitoring experience within the medical device industry.
• Strong knowledge of US and international clinical regulations and guidance.

Technical Requirements

• Proven ability to make independent decisions and work effectively within a fast-moving environment.
• Requires 3+ years of industry sponsor experience (medical device), with a focus on site management activities.
• Experience working for a start-up or early-stage company preferred
• Experience with Electronic Data Capture (EDC) systems, Clinical Trial Management Systems (CTMS), and electronic Trial Master File (eTMF) systems.
• Proficient in Acrobat Adobe, Microsoft Word, Access, Excel, and Project; and the ability to quickly become proficient in a variety of other software
• Excellent oral and written communication skills and critical thinking skills
• Understanding of medical terminology
• Ability to perform well-defined procedures and work independently
• Ability to exhibit good judgment, be creative, and achieve aggressive goals
• Flexibility to work within multiple time zones
• Ability to travel, up to 45%. Overnight travel is required

Managerial Experience

• 3-5 years related project management experience