Clinical Operations Manager

Groom & Associés / Associates; United States; Remote; USD 140,000 - 190,000; Full time

Job summary

Groom & Associates seeks a highly driven Senior Study Lead / Clinical Operations Manager to lead clinical trial operations across the United States and Canada, with a strong FDA IDE trial background. This home-based role involves extensive travel and hands-on site management, startup activation of centers, and collaboration with investigators, CROs and hospital staff.

Ideal candidates bring direct FDA experience, ISO 14155 familiarity and proactive communication, with travel up to 60% across the

Qualifications

• Direct FDA clinical trial experience is mandatory; hands-on operation on FDA-regulated trials preferred.
• Experience in FDA IDE / investigational medical device trials highly valued.
• Hands-on clinical trial operations and/or study management with strong documentation.
• Working knowledge of ISO 14155 and GCP.
• Strong scientific writing, data-analysis and documentation skills.

Responsibilities

• Drive operational progress of clinical studies at the site level.
• Support the start-up, activation and ongoing management of new clinical trial centers.
• Take a hands-on operational role in an ongoing FDA IDE clinical trial.
• Ensure studies progress according to project plans, timelines, budgets and quality standards.
• Work closely with the CRO while maintaining sponsor-side oversight.
• Establish relationships with study teams, investigators and ICU staff.
• Motivate sites to maintain screening and enrollment momentum.
• Ensure clear communication with sites and internal stakeholders.
• Support regulatory, data-related activities and study documentation.
• Ensure FDA requirements and ISO 14155 compliance.
• Collaborate with cross-functional teams and external partners.
• Travel regularly to sites across the United States and Canada.

Skills

FDA IDE experience

Clinical operations

Site management

Regulatory writing

Excellent communication

Travel readiness

Education

Scientific degree (medical/life sciences)

Job description

Senior Study Lead / Clinical Operations Manager

with Strong FDA IDE Clinical Trial Experience

Ideal U.S. Locations: Minneapolis–St. Paul, Boston/Cambridge, New York/New Jersey, Chicago, San Francisco Bay Area, Washington DC/Maryland or San Diego

Work Arrangement: Home-based with extensive travel throughout the United States and Canada

Travel: Up to approximately 60%; typically less, but candidates must be comfortable with occasional weekends and periods of 2–3 consecutive weeks on-site

Full time position.

About the Company & Innovation

Our client is an innovative international medical technology company developing a novel therapy for critically ill patients requiring mechanical ventilation.

Patients on mechanical ventilation do not actively breathe on their own, which can lead to deterioration of the diaphragm, the body's core breathing muscle. Our client's innovative technology has been developed to stimulate the diaphragm of intensive care patients.

The company is currently enrolling patients in an FDA IDE clinical trial, alongside several smaller clinical trials in the United States as part of a comprehensive clinical evidence strategy.

About the Position

Our client is seeking a highly driven and hands-on Senior Study Lead / Clinical Operations Manager to support and drive clinical trial operations across the United States and Canada.

This is a highly operational, field-oriented role requiring someone who can take ownership of study execution and work directly with clinical trial sites, investigators, study teams and hospital stakeholders.

A major component of the role will involve the formal and motivational aspects of starting up and driving new clinical trial centers participating in an FDA trial, other regulated clinical trials and investigator-initiated studies.

The successful candidate will combine strong clinical trial expertise with exceptional follow-through, communication and interpersonal skills. We are looking for someone who is highly proactive, fast-moving, organized and comfortable taking ownership in a dynamic environment.

Key Responsibilities

• Drive and manage the operational progress of clinical studies at the site level.
• Support the start-up, activation and ongoing management of new clinical trial centers.
• Take a hands-on operational role in an ongoing FDA IDE clinical trial.
• Ensure studies progress according to project plans, timelines, budgets and required quality standards.
• Work closely with the study CRO while maintaining strong sponsor-side oversight and accountability.
• Establish close working relationships with study teams, screening teams, Principal Investigators, Key Opinion Leaders and ICU medical staff.
• Motivate and engage clinical sites to maintain study momentum, screening and enrollment.
• Ensure clear communication and prompt follow-up with sites and internal stakeholders.
• Support clinical protocols, study documentation, regulatory requirements and clinical data-related activities.
• Ensure compliance with applicable FDA requirements and ISO 14155 clinical trial Good Clinical Practice.
• Collaborate closely with cross-functional team members, scientists and external clinical partners throughout all study phases.
• Travel regularly to clinical trial sites throughout the United States and Canada.

Non-Negotiable Requirements

Candidates must meet the following criteria:

• Direct FDA clinical trial experience is mandatory. Candidates must have held an operational or full-responsibility role on at least one FDA-regulated clinical trial.
• Strong preference for candidates with direct FDA IDE / investigational medical device trial experience.
• Demonstrated hands-on clinical trial operations and/or study management experience, including responsibility for keeping studies on track.
• Working knowledge of ISO 14155 and clinical trial Good Clinical Practice.
• Strong clinical/scientific writing, documentation and data-analysis capabilities.
• A scientific educational background. Medical, life sciences or biology backgrounds are preferred; other relevant scientific disciplines may be considered.
• Ability and willingness to travel extensively throughout the United States and Canada, including occasional weekends and, when required, 2–3 consecutive weeks on-site.
• Ability to work effectively and confidently with investigators, clinical research teams and senior hospital stakeholders.
• Highly proactive, fast-paced and driven working style with excellent follow-through.

Preferred / Asset Experience

The following experience would be particularly valuable:

• FDA IDE medical device clinical trial experience.
• Critical care, ICU or related hospital-based clinical research.
• Medical device monitoring experience, particularly involving critical care technologies.
• Experience starting up and activating new clinical trial sites.
• Experience with investigator-initiated studies.
• Experience working with leading university hospitals and Key Opinion Leaders.
• Study nurse background combined with strong clinical trial operations experience.

Education / Background

A scientific degree is required, with preference for candidates from medical, biological, life sciences or closely related scientific disciplines.

Candidates with a study nursing background may also be considered where they bring strong clinical trial operations, documentation and analytical experience.

Physicians may be considered where their experience is highly hands-on and operational.

Who Will Succeed in This Role

This position is best suited to someone who enjoys being close to the clinical sites and the action rather than managing studies exclusively from behind a desk.

The successful candidate will be comfortable taking initiative, creating urgency, motivating sites, following up persistently and solving operational problems quickly. They must also bring the rigor required for an FDA-regulated medical device study, including strong documentation, writing and data-analysis capabilities.

This is a highly visible position working directly with an international scientific team and clinical investigators at leading hospitals throughout the United States and Canada.