Clinical Research Manager

Job Description:

Galaxy Therapeutics is currently seeking a Clinical Research Manager to support an upcoming US IDE trial for a novel medical device in the neurovascular space. This position will assist in developing an internal clinical research team to ensure FDA compliant IDE trial oversight to successfully demonstrate the safety and efficacy of a novel aneurysm treatment system.

This role will be primarily responsible for managing an FDA multi-center IDE trial in USA and Europe.

This is a hybrid position that will have the flexibility to work remotely but will be required to be in the office for team collaboration and reporting 2-3 days per week.

Current clinical research coordinators or CRO administration managers are encouraged to apply.

FDA experience, IDE experience, EDC experience and managing multi-site clinical trial in USA and Europe is a plus. Clinical trial monitoring and auditing experience. Data management, starting web based electronic capturing data base and image upload service with our vendors or finding vendors.

Primary Responsibilities

• Acts as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites.
• Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.
• Performs clinical study site management/monitoring activities in compliance with International Council for Harmonisation Good Clinical Practice (ICH-GCP), Sponsor Standard Operating Procedures (SOPs), Local Laws & Regulations, Protocol, Site Monitoring Plan, and associated documents.
• Gains an in-depth understanding of the study protocol and related procedures.
• Coordinates and manages various tasks in collaboration with other sponsor roles to achieve Site Ready.
• Participates in site selection and validation activities.
• Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits, and records clear, comprehensive, and accurate visit and non-visit contact reports appropriately in a timely manner.
• Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out.
• Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.
• Identifies, assesses, and resolves site performance, quality, or compliance problems and escalates issues to Company management.
• Manages and maintains information and documentation in Clinical Trial Management System (CTMS), Trial Master File (eTMF) and various other systems as appropriate and per timelines.
• Leads audit/inspection activities as needed.
• Serve as main point of contact for enrolling center coordinators.
• Performs remote and on-site monitoring and oversight activities using various tools to ensure; 1) Data generated at site are complete, accurate and unbiased and 2) Subjects’ right, safety and well-being are protected

Preferred Experience

• Demonstrated project management skills and the able to lead clinical trials logistic planning, key vendor establishment, website development, data base development, and image upload managment
• Experience with clinical trial management.
• Experience or familiarity with FDA 510k, PMA and HDE approvals and pre-submissions
• Experience with IDE FDA Ongoing reporting requirements and compliance regulations
• Clinical trial auditing and on site/remote monitoring
• Site initiation and study start-up management
• Patient enrollment strategies

Education Minimum Requirements

• Bachelors Degree in Nursing, Healthcare Administration, or a related field
• Masters degree preferred

Required Experience

• Min. 2 years of direct experience in clinical research; trial management, clinical research associate, or clinical trial administration.

Travel

• Ability to travel domestically and internationally approximately 20% of working time

Core Competency Expectations

• Fluent in Local Languages and English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively.
• Excellent understanding and working knowledge of clinical research, phases of clinical trials, current International Conference on Harmonization Good Clinical Practice (GCP/ICH) & country clinical research law & guidelines.
• Excellent understanding of Global, Country/Regional Clinical Research Guidelines, and ability to work within these guidelines.
• Demonstrated ability to mentor/lead
• Hands-on knowledge of Good Documentation Practices
• Proven Skills in Site Management including independent management of site performance and patient recruitment
• Demonstrated high level of monitoring skill with independent professional judgment.
• Good IT skills (Use of MS office, use of various clinical IT applications on the computer, tablet, and mobile devices) and ability to adapt to new IT applications on various devices.
• Ability to understand and analyze data/metrics and act appropriately

Behavioral Competency Expectations

• Effective time management, organizational and interpersonal skills, conflict management, problem-solving skills
• Able to work highly independently across multiple protocols, sites and therapy areas
• High sense of accountability/urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment

Job Type: Full-time

Pay: $66,590.26 - $80,194.72 per year

Benefits:

• Paid time off

Schedule:

• 8 hour shift

Ability to Relocate:

• Toledo, OH 43612: Relocate before starting work (Required)

Work Location: In person

Salary : $66,590 - $80,195