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Clinical Trials Manager

2 months 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 accommodate increasing demand.

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 manager will collaborate with various departments, including manufacturing, engineering, quality assurance, product development, legal, and regulatory affairs, to ensure adherence to regulatory standards. A solid understanding of both US and international clinical regulations, policies, and guidance documents is essential, including Good Clinical Practices, Clinical Evaluations, and study design.

Section III - ESSENTIAL POSITION FUNCTIONS:


• Lead project management initiatives for clinical collaborations, including outreach, initial meetings, data analysis, and follow-up.


• Support multiple phases of clinical studies, such as planning, site qualification, investigator selection, monitoring, and trial closure.


• Oversee the collection and management of clinical trial data to guarantee accuracy and compliance.


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


• Assist in the formulation of study budgets, contracts, and agreements to promote trial execution.


• Contribute to the preparation of regulatory submissions and maintain 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 monitor 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 aspects of US Regulatory submissions and EU MDD technical files.


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


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


• Support the preparation of funding proposals for submission to governmental and private-sector entities.

Section IV - MINIMUM COMPETENCY REQUIREMENTS:

Relevant Work Experience:


• A minimum of 5 years of experience in the biotech or pharmaceutical sector.


• Exceptional communication skills.


• An 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 management of Contract Research Organizations (CROs).


• Ability to effectively prepare clinical documentation.


• Experience in personnel and project management.


• Excellent multitasking skills with a focus on prioritization.


• Outstanding communication skills for effective collaboration.


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


• Capability to work independently as well as 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)