Clinical Trials Operations Manager

2 weeks ago

Colorado Springs, Colorado, United States Raise Full time

Position: Manager, Clinical Development

Salary Range: $130K - $160K

Location: Remote

Raise is currently seeking a qualified candidate for one of our esteemed clients in the Medical Devices industry. As a recognized leader in their field, they are expanding their workforce to address increasing market demands.

JOB DESCRIPTION

Section I - POSITION TITLE:

Manager, Clinical Development

Section II - POSITION SUMMARY:

The Manager, Clinical Development is accountable for overseeing high-caliber clinical trials that yield advanced clinical evidence. This role encompasses all facets of clinical partnerships, trial execution, reporting, and documentation. The position requires collaboration with manufacturing, engineering, quality assurance, product development, legal, and regulatory affairs to ensure adherence to regulatory standards. A comprehensive understanding of US and international clinical regulations, policies, and guidelines is essential, including Good Clinical Practices, Clinical Evaluations, and Post Market Evaluations.

Section III - ESSENTIAL POSITION FUNCTIONS:


• Lead project management initiatives for clinical collaborations, which include prospecting, introductory discussions, data analysis, and follow-up.


• Support various stages of clinical studies, including planning, site qualification, investigator selection, monitoring, and trial closure.


• Supervise the collection and management of clinical trial data to ensure precision and compliance.


• Facilitate communication regarding all trial-related matters among stakeholders to guarantee seamless operations.


• Assist in formulating study budgets, contracts, and agreements to enable trial execution.


• Contribute to the preparation of regulatory submissions and ensure compliance throughout the trial process.


• Aid in the development and implementation of internal and external strategies to further clinical development objectives.


• Manage clinical field corrections and track/report responses to clinical field corrections and recalls.


• Provide insights on analyses of clinical regulatory guidance documents, regulations, or directives impacting company products and operations.


• Support Regulatory and Quality teams in maintaining clinical components of US Regulatory submissions and EU MDD technical files.


• Organize and promote training activities related to clinical matters for internal stakeholders.


• Lead or assist in clinical and scientific initiatives to drive project success.


• Assist in preparing funding proposals for submission to governmental and private-sector entities.

Section IV - MINIMUM COMPETENCY REQUIREMENTS:

Relevant Work Experience:


• 5+ years of experience in the biotech or pharmaceutical sectors.


• Strong communication abilities.


• Advanced degree in immunology or a related field is required (PhD or PharmD preferred).

Other Skills, Knowledge, and Abilities:


• Strong project management capabilities.


• Proficiency in clinical study design and execution, including CRO management.


• Ability to effectively prepare clinical documentation.


• Experience in personnel and project management.


• Excellent multitasking skills with a focus on prioritization.


• Exceptional communication skills for effective collaboration.


• Proficiency in commonly used software for word processing and data analysis.


• Ability to work independently and collaboratively within a team environment.

Required Training: Essentials of ISO 13485:2016, New Hire Orientation, Quality Awareness, Risk Management Procedure, Advertising, Promotion & Labeling Requirements, Adverse Event Reporting, FDA Inspection, US Regulatory Submissions, Overview of Regulatory Requirements: Medical Devices, Introduction to the Quality System Regulation (QSR)

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