Clinical Trials 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 a prominent client in the Medical Devices industry. As a recognized leader in their field, this organization is expanding its workforce to accommodate increasing demand.

JOB OVERVIEW

Section I - POSITION TITLE:

Manager, Clinical Development

Section II - POSITION SUMMARY:

The Manager of 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. Familiarity with both US and international clinical regulations, policies, and guidance documents is essential, including Good Clinical Practices, Clinical Evaluations, and study design.

Section III - KEY RESPONSIBILITIES:


• Lead project management initiatives for clinical collaborations, including prospecting and follow-up activities.


• Support various stages of clinical studies, such as planning, site qualification, and monitoring.


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


• Facilitate effective communication among stakeholders regarding all trial-related matters.


• Assist in the development of study budgets, contracts, and agreements to enable trial execution.


• Contribute to the preparation of regulatory submissions and maintain compliance throughout the trial lifecycle.


• Aid in formulating and implementing strategies to further clinical development objectives.


• Manage clinical field corrections and track responses to any necessary corrections or recalls.


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


• Support Regulatory and Quality teams in maintaining clinical components of US Regulatory submissions.


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


• Lead or assist in scientific activities to ensure project success.


• Help prepare funding proposals for submission to governmental and private-sector entities.

Section IV - MINIMUM QUALIFICATIONS:

Relevant Work Experience:


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


• Excellent 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 CROs.


• Ability to effectively prepare clinical documentation.


• Experience in managing personnel and projects.


• Exceptional multitasking skills with a focus on prioritization.


• Outstanding communication skills for effective collaboration.


• Proficiency in standard software applications for word processing and data analysis.


• Capacity to work independently as well as collaboratively within a team.

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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