Clinical Development Manager

Position: Manager, Clinical Development

· Starting Range: $130K - $160K

· Location: Denver, CO (Remote)

We at Raise are hiring for one of our top clients in the Medical Devices sector. After establishing themselves as an industry leader, they’re now expanding their team to meet rising demand.

We’re hiring right now; if you’re interested, apply below for your chance to join a great place to work.

JOB DESCRIPTION

Section I - POSITION TITLE:

Manager, Clinical Development

Section II -

POSITION SUMMARY: Manager, Clinical Development

Responsible for management of high-quality clinical trials leading to advanced clinical evidence including all aspects of clinical collaborations, clinical trials, clinical reporting and documentation. Supports manufacturing, engineering, quality assurance, product development, legal, and regulatory affairs as required to assure regulatory compliance. Knowledge in US and international clinical regulations, standards, policies, and guidance documents, including but not limited to: Good Clinical Practices, Clinical Evaluations, Post Market Evaluations, study design and device use, training & support, data reporting, and event reporting. Build and maintain a Trial Master File for trials sponsored by the company. Works closely with the clinical team to plan and manage clinical and research projects.

Section III - ESSENTIAL POSITION FUNCTIONS:

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Lead project management efforts for clinical collaborations, including prospecting, introductory meetings, data review, and follow-up.

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Support various phases of clinical studies, including study planning, site qualification, investigator selection, monitoring, and closeout.

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

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

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

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

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Assist in developing and executing internal and external strategies to advance clinical development goals.

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

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Provide input on analyses of clinical regulatory guidance documents, regulations, or directives affecting company products and operations.

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Support Regulatory and Quality in maintaining clinical aspects of US Regulatory submissions and EU MDD technical files.

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Plan, promote, and organize training activities related to clinical issues for internal stakeholders.

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

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Assist in preparing funding proposals for submission to government and private-sector institutions.

Section IV - MINIMUM COMPETENCY REQUIREMENTS:

Relevant Work Experience:

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5+ years of experience in the biotech or pharmaceutical industry.

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Strong communication skills.

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Advanced degree in immunology or related discipline required. (PhD or PharmD preferred)

Other Skills, Knowledge, and Abilities:

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Strong project management skills.

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

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Ability to prepare clinical documentation effectively.

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Experience in personnel and project management.

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Excellent multitasking abilities with a focus on prioritization.

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Exceptional communication skills for effective collaboration.

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

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Ability to work both independently and collaboratively in a team setting.

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)