Preclinical Program Manager

This is a fully remote position, open to applicants in United States.

📋 Description

• Act as the primary coordination hub for multiple concurrent preclinical studies.

• Develop and maintain comprehensive master timelines and ongoing trackers that detail CRO status, study advancements, contracting updates, and indication readiness.

• Track dependencies and milestones, and proactively identify schedule risks.

• Serve as the operational liaison between the New Applications team and regulatory, clinical affairs, upstream marketing, RAD, risk management, and operations.

• Oversee daily logistics for in vivo, ex vivo, and in vitro studies, as well as work conducted by CROs.

• Manage the scheduling of activities, shipments, sample tracking, meetings, follow-up on action items, and deliverables from the study kickoff to report delivery.

• Organize and maintain all study documentation, including protocols, reports, SOW/contracting paperwork, and program files.

• Ensure proper version control, completeness, and retrieval of records for regulatory, clinical, and audit purposes.

• Assist in coordinating CRO and vendor activities by monitoring SOW execution, milestones, invoices, and associated costs.

• Aid in scheduling vendor check-ins and escalate any issues to the Director and Manager.

• Provide logistical support for KOL engagements and lab/training events.

• Coordinate scheduling, travel, meetings, materials, notes, and follow-up items related to events.

• Compile and distribute program status updates, meeting notes, and action item lists.

• Ensure the Director, Manager, and broader team have visibility into the program's status.

⛳️ Requirements

• 10–15 years of experience in the medical device, medtech, or regulated life sciences industries.

• Proven experience in research coordination, clinical/preclinical research support, or project/program coordination.

• Active license as a clinical or allied health professional, such as a radiologic technologist, sonographer, registered nurse, or equivalent.

• Capability to juggle multiple tasks, timelines, and stakeholders concurrently.

• Strong attention to detail is essential.

• Ability to thrive in a fast-paced, multi-program environment.

• Experience in coordinating efforts between internal teams and external vendors.

• A clinical background as a licensed professional is mandatory.

• An advanced degree is not a prerequisite.

• Outstanding organizational skills and a track record of reliable task completion across multiple workstreams and deadlines.

• Proficient with project tracking, spreadsheets, and document management tools.

• Ability to create and maintain clear trackers and timelines.

• Strong written and verbal communication capabilities.

• Skilled in coordination across teams and with external partners.

• Familiarity with GLP/non-GLP study frameworks, ISO 10993, or medical device development processes is advantageous.

• Eagerness to learn GLP/non-GLP study frameworks, ISO 10993, or medical device development processes is crucial.

• The employer will not provide visa sponsorship for this position.

🏝️ Benefits

• Health insurance

• Dental insurance

• Vision insurance

• Life insurance

• Short-term disability insurance

• Long-term disability insurance

• 401(k)

• Paid time off

• Comprehensive benefits package for full-time employees