Publié il y a 10 jours
Clinical Trial Manager – Cardiovascular Medical Device
@ MiRus®
Montréal, Québec
SIGNAUX
En bref
MiRus, a cardiovascular and orthopedic medical device company in Marietta, GA, is hiring a full-time Clinical Trial Manager to support cardiovascular clinical studies from start through closure. The role covers protocol and regulatory document writing, CRO and site coordination, safety monitoring support and study tracking. Monday to Friday, 8am to 5pm, with competitive compensation, options, full benefits and relocation assistance.
Responsabilités :
- Write and edit study protocols, reports and regulatory documents
- Manage clinical studies from start to closure
- Serve as point of contact for investigators, sites and CRO
- Support safety monitoring and DSMB/CEC meetings
- Track study status and update trial dashboards
Résumé des exigences :
- Bachelor's or Master's in nursing with cardiac clinical experience
- At least 2 years in clinical research
- Knowledge of FDA regulations and ICH/GCP
- Experience in medical device clinical trials
- CRA certification desired
Outils et compétences
Source et dates
Type de source non vérifié · apify-linkedin
- Date publiée par l’employeur
- 2026-11-04
- Première détection par notre source
- 2026-11-14
- Mise à jour du dossier source
- 2026-11-14
Ces dates décrivent le dossier source, pas une vérification en direct du recrutement. Consultez l’offre originale.
Détails du poste
| Niveau | Intermédiaire |
| Domaine | Médecins et pratique avancée |
| Expérience | 2 an(s) et plus |
| Heures par semaine | 40 |
| Horaire | jour |
| Déplacements | avion : minimes · route : minimes |
| Milieu de travail | Bureau |
| Position | Surtout assis |
| Exigences physiques | physique faible · ordinateur élevé |
| Langues | English |
| Permis et certifications | CRA certification |
| Formation | Baccalauréat (exigé), Maîtrise (préféré) |
| Domaines d’études | Nursing |
| Avantages mentionnés | Congés payés généreux, Horaire flexible, Régime de retraite, Aide à la réinstallation, Actions ou participation, Mieux-être |
Résumé et détails rédigés par l’IA à partir de l’offre; l’offre de l’employeur fait foi.
MiRus®
| Champ | Valeur |
|---|---|
| Offres sur Jobsy | 1 |
Description
Posted 9 months ago
Clinical Trial Manager – Cardiovascular Medical Device
MiRus is an innovative healthcare company with a growing portfolio of cardiovascular and orthopedic products and deep proprietary technology in both implants and procedural solutions. MiRus was started by a team of experienced entrepreneurs with a history of creating disruptive technologies and very successful, highly valued companies.
Job Summary
We offer competitive compensation, options, and full benefits.
Assist with the management of cardiovascular clinical studies for MiRus products with a focus on adherence to critical timelines, high-caliber document development and quality data collection. The applicant should possess strong critical thinking skills and the ability to comprehend technical subject matter to effectively contribute to the organization.
Responsibilities
♦ Contribute to content generation, writing and editing of study protocols, amendments, informed consents, committee charters, study reports, monitoring plans, and other related clinical and regulatory documents.
♦ Assist with the management of investigational studies from start through study closure.
♦ Engage in new study trial design with cross functional teams, including clinical and pre-clinical research and development groups.
♦ Contribute to the development of CRFs.
♦ Assist with the formulation of instructional materials and training of investigators, study coordinators and associated study site personnel on the conduct of the clinical trials, as applicable
♦ Assist Study Manager with safety monitoring including preparing supporting documentation for CEC and/or DSMB, meetings, agenda, data review, presentations, and updating relevant trackers as applicable.
♦ Serve as a point of contact between clinical site investigators and the MiRus team.
♦ Work with investigators and site personnel to quickly and effectively resolve discrepancies.
♦ May be responsible for patient accruals and tracking payments to sites for clinical study programs.
♦ Serve as a point of contact between CRO personnel and MiRus.
♦ Oversee/support CRO and field study monitors, with monitoring related items and follow-up on study tasks.
♦ Monitor ongoing compliance to study protocols in accordance with applicable regulations and GCP, work instructions, guidelines and/or policies.
♦ Provide continuous data review of source documents, case report forms, data reports as appropriate.
♦ Assist in review of monitoring reports and tracking of action items.
♦ Review source documentation to confirm subject eligibility for clinical trials.
♦ Track and upload study imaging.
♦ Manage clinical study documentation (trial master file and study related tracking).
♦ Update and design as needed study dashboards, study trackers and other applicable study documents to provide regular updates on trial status to Study Manager.
♦ Interact with data management, as applicable.
♦ Support applications and technical files as needed.
♦ Assist with preparation for investigators meetings.
Requirements
♦ Bachelor’s or Master’s degree in nursing with clinical experience in the cardiac field (CCU, CVOR, Cath Lab) and experience in a clinical research role. CRA certification desired.
♦ At least 2 years of experience in clinical research role, preferably in cardiovascular medical device.
♦ Experience in clinical trials and/or post-market registries in the U.S., Australian and/or European Union, with other geographies desired.
♦ Current knowledge of medical device clinical trials design and best practices.
♦ Proficient knowledge of FDA regulations and ICH/GCP guidelines, guidance documents, and other applicable regulations and standards, and implementation of these standards in the medical device industry, in the U.S. and all countries in which trials are conducted.
♦ General application of medical terminology (cardiovascular specific preferred).
Benefits
MiRus offers competitive compensation, options, full benefits, and relocation assistance.
♦ 401(k)
♦ Dental insurance
♦ Vision insurance
♦ Disability insurance
♦ Employee assistance program
♦ Flexible spending account or Health Savings Account
♦ Health insurance
♦ Life insurance
♦ Paid time off
Schedule
♦ Monday to Friday (8am – 5pm)
Work Location:
♦ Marietta, GA
♦ Position may require domestic travel up to 10%, however this is an in-house position.
Interested ? Please complete the contact information below and submit your resume to [email protected]
Apply For This Job
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Email*
A valid email address is required.
Phone*
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Attach Resume*
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Clinical Trial Manager – Cardiovascular Medical Device
MiRus is an innovative healthcare company with a growing portfolio of cardiovascular and orthopedic products and deep proprietary technology in both implants and procedural solutions. MiRus was started by a team of experienced entrepreneurs with a history of creating disruptive technologies and very successful, highly valued companies.
Job Summary
We offer competitive compensation, options, and full benefits.
Assist with the management of cardiovascular clinical studies for MiRus products with a focus on adherence to critical timelines, high-caliber document development and quality data collection. The applicant should possess strong critical thinking skills and the ability to comprehend technical subject matter to effectively contribute to the organization.
Responsibilities
♦ Contribute to content generation, writing and editing of study protocols, amendments, informed consents, committee charters, study reports, monitoring plans, and other related clinical and regulatory documents.
♦ Assist with the management of investigational studies from start through study closure.
♦ Engage in new study trial design with cross functional teams, including clinical and pre-clinical research and development groups.
♦ Contribute to the development of CRFs.
♦ Assist with the formulation of instructional materials and training of investigators, study coordinators and associated study site personnel on the conduct of the clinical trials, as applicable
♦ Assist Study Manager with safety monitoring including preparing supporting documentation for CEC and/or DSMB, meetings, agenda, data review, presentations, and updating relevant trackers as applicable.
♦ Serve as a point of contact between clinical site investigators and the MiRus team.
♦ Work with investigators and site personnel to quickly and effectively resolve discrepancies.
♦ May be responsible for patient accruals and tracking payments to sites for clinical study programs.
♦ Serve as a point of contact between CRO personnel and MiRus.
♦ Oversee/support CRO and field study monitors, with monitoring related items and follow-up on study tasks.
♦ Monitor ongoing compliance to study protocols in accordance with applicable regulations and GCP, work instructions, guidelines and/or policies.
♦ Provide continuous data review of source documents, case report forms, data reports as appropriate.
♦ Assist in review of monitoring reports and tracking of action items.
♦ Review source documentation to confirm subject eligibility for clinical trials.
♦ Track and upload study imaging.
♦ Manage clinical study documentation (trial master file and study related tracking).
♦ Update and design as needed study dashboards, study trackers and other applicable study documents to provide regular updates on trial status to Study Manager.
♦ Interact with data management, as applicable.
♦ Support applications and technical files as needed.
♦ Assist with preparation for investigators meetings.
Requirements
♦ Bachelor’s or Master’s degree in nursing with clinical experience in the cardiac field (CCU, CVOR, Cath Lab) and experience in a clinical research role. CRA certification desired.
♦ At least 2 years of experience in clinical research role, preferably in cardiovascular medical device.
♦ Experience in clinical trials and/or post-market registries in the U.S., Australian and/or European Union, with other geographies desired.
♦ Current knowledge of medical device clinical trials design and best practices.
♦ Proficient knowledge of FDA regulations and ICH/GCP guidelines, guidance documents, and other applicable regulations and standards, and implementation of these standards in the medical device industry, in the U.S. and all countries in which trials are conducted.
♦ General application of medical terminology (cardiovascular specific preferred).
Benefits
MiRus offers competitive compensation, options, full benefits, and relocation assistance.
♦ 401(k)
♦ Dental insurance
♦ Vision insurance
♦ Disability insurance
♦ Employee assistance program
♦ Flexible spending account or Health Savings Account
♦ Health insurance
♦ Life insurance
♦ Paid time off
Schedule
♦ Monday to Friday (8am – 5pm)
Work Location:
♦ Marietta, GA
♦ Position may require domestic travel up to 10%, however this is an in-house position.
Interested ? Please complete the contact information below and submit your resume to [email protected]
Apply For This Job
Name*
Email*
A valid email address is required.
Phone*
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