Clinical Trials Manager

1 week ago

Colorado Springs, Colorado, United States Raise Full time

Position: Manager, Clinical Development

Salary Range: $130K - $160K

Location: Remote

Raise is seeking a qualified candidate for one of our esteemed clients in the Medical Devices industry. As a recognized leader in the field, they are expanding their workforce to address 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 manufacturing, engineering, quality assurance, product development, legal, and regulatory teams to ensure adherence to regulatory standards. Proficiency in both US and international clinical regulations, policies, and guidance documents is essential, including Good Clinical Practices, Clinical Evaluations, and Post Market Evaluations.

Section III - ESSENTIAL POSITION FUNCTIONS:


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


• Support various 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 ensure accuracy and compliance.


• Facilitate communication on all trial matters among stakeholders to ensure seamless operations.


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


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


• Assist in formulating and executing internal and external strategies to advance 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 aspects of US Regulatory submissions and EU MDD technical files.


• Plan, promote, and organize training activities related to clinical issues 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 institutions.

Section IV - MINIMUM COMPETENCY REQUIREMENTS:

Relevant Work Experience:


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


• 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 prepare clinical documentation effectively.


• 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 packages for word processing and data analysis.


• Ability to work both independently and collaboratively in 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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