Manage projects to ensure statistics tasks are performed within the entire project timeline. Keep ... and medical device firms. For more information, visit www.ctifacts.com Why CTI? * Advance Your ...
Manage projects to ensure statistics tasks are performed within the entire project timeline. Keep ... and medical device firms. For more information, visit www.ctifacts.com Why CTI? * Advance Your ...
Biomedical Engineering Tutor
Lexington, KY · Remote
$18 - $40/hr
Skilled at breaking down physiological system modeling, biomechanical analysis, and medical device ... project guidance to support undergraduate biomedical engineering students bridging life sciences ...
Biomedical Engineering Tutor
Lexington, KY · Remote
$18 - $40/hr
Skilled at breaking down physiological system modeling, biomechanical analysis, and medical device ... project guidance to support undergraduate biomedical engineering students bridging life sciences ...
Biomedical Engineering Tutor
Louisville, KY · Remote
$18 - $40/hr
Skilled at breaking down physiological system modeling, biomechanical analysis, and medical device ... project guidance to support undergraduate biomedical engineering students bridging life sciences ...
Biomedical Engineering Tutor
Louisville, KY · Remote
$18 - $40/hr
Skilled at breaking down physiological system modeling, biomechanical analysis, and medical device ... project guidance to support undergraduate biomedical engineering students bridging life sciences ...
Associates Degree and 6+ years of relevant sales, clinical, or related experience in medical device ... Ability to manage multiple accounts and priorities in a fast-paced field environment * Experience ...
Associates Degree and 6+ years of relevant sales, clinical, or related experience in medical device ... Ability to manage multiple accounts and priorities in a fast-paced field environment * Experience ...
Associates Degree and 6+ years of relevant sales, clinical, or related experience in medical device ... Ability to manage multiple accounts and priorities in a fast-paced field environment * Experience ...
Associates Degree and 6+ years of relevant sales, clinical, or related experience in medical device ... Ability to manage multiple accounts and priorities in a fast-paced field environment * Experience ...
Associates Degree and 6+ years of relevant sales, clinical, or related experience in medical device ... Ability to manage multiple accounts and priorities in a fast-paced field environment * Experience ...
Associates Degree and 6+ years of relevant sales, clinical, or related experience in medical device ... Ability to manage multiple accounts and priorities in a fast-paced field environment * Experience ...
Associates Degree and 6+ years of relevant sales, clinical, or related experience in medical device ... Ability to manage multiple accounts and priorities in a fast-paced field environment * Experience ...
Associates Degree and 6+ years of relevant sales, clinical, or related experience in medical device ... Ability to manage multiple accounts and priorities in a fast-paced field environment * Experience ...
Associates Degree and 6+ years of relevant sales, clinical, or related experience in medical device ... Ability to manage multiple accounts and priorities in a fast-paced field environment * Experience ...
Associates Degree and 6+ years of relevant sales, clinical, or related experience in medical device ... Ability to manage multiple accounts and priorities in a fast-paced field environment * Experience ...
Territory Manager, Alternative Care
Louisville, KY · On-site +1
$85K/yr
Perform other duties and projects as requested. Minimum & Preferred Qualifications and Experience ... Medical Device solutions to Acute care or Alternate Care markets. * Experience calling on Alternate ...
Territory Manager, Alternative Care
Louisville, KY · On-site +1
$85K/yr
Perform other duties and projects as requested. Minimum & Preferred Qualifications and Experience ... Medical Device solutions to Acute care or Alternate Care markets. * Experience calling on Alternate ...
... Medical Device industry is required. Preferred Qualifications * Ability to examine business ... Remote ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Yes, 75 % of the Time MEDICAL ...
... Medical Device industry is required. Preferred Qualifications * Ability to examine business ... Remote ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Yes, 75 % of the Time MEDICAL ...
... Medical Device industry is required. Preferred Qualifications * Ability to examine business ... Remote ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Yes, 75 % of the Time MEDICAL ...
... Medical Device industry is required. Preferred Qualifications * Ability to examine business ... Remote ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Yes, 75 % of the Time MEDICAL ...
Vice President, Global Medical Affairs
Covington, KY · On-site +1
Ensure appropriate review and management of safety data, including Serious Adverse Events (SAEs ... and medical device firms. For more information, visit www.ctifacts.com Why CTI? * Advance Your ...
Vice President, Global Medical Affairs
Covington, KY · On-site +1
Ensure appropriate review and management of safety data, including Serious Adverse Events (SAEs ... and medical device firms. For more information, visit www.ctifacts.com Why CTI? * Advance Your ...
Vice President, Global Medical Affairs
Covington, KY · On-site +1
Ensure appropriate review and management of safety data, including Serious Adverse Events (SAEs ... and medical device firms. For more information, visit www.ctifacts.com Why CTI? * Advance Your ...
Vice President, Global Medical Affairs
Covington, KY · On-site +1
Ensure appropriate review and management of safety data, including Serious Adverse Events (SAEs ... and medical device firms. For more information, visit www.ctifacts.com Why CTI? * Advance Your ...
System Test and Validation Lead
Louisville, KY · On-site +1
Ability to lead projects or workstreams * Ability to manage and prioritize multiple tasks in a fast ... medical device, or clinical * Experience leading validation deliverables for GxP systems, including ...
System Test and Validation Lead
Louisville, KY · On-site +1
Ability to lead projects or workstreams * Ability to manage and prioritize multiple tasks in a fast ... medical device, or clinical * Experience leading validation deliverables for GxP systems, including ...
System Test and Validation Lead
Louisville, KY · On-site +1
Ability to lead projects or workstreams * Ability to manage and prioritize multiple tasks in a fast ... medical device, or clinical * Experience leading validation deliverables for GxP systems, including ...
System Test and Validation Lead
Louisville, KY · On-site +1
Ability to lead projects or workstreams * Ability to manage and prioritize multiple tasks in a fast ... medical device, or clinical * Experience leading validation deliverables for GxP systems, including ...
System Test and Validation Lead
Louisville, KY · On-site +1
Ability to lead projects or workstreams * Ability to manage and prioritize multiple tasks in a fast ... medical device, or clinical * Experience leading validation deliverables for GxP systems, including ...
System Test and Validation Lead
Louisville, KY · On-site +1
Ability to lead projects or workstreams * Ability to manage and prioritize multiple tasks in a fast ... medical device, or clinical * Experience leading validation deliverables for GxP systems, including ...
Medical Writing Manager
Lexington, KY · Remote
$50 - $80/hr
Remote micro1 is engaging Medical Writers / Clinical Document Authors to participate in a customer ... Collaborate with project leads to refine evaluation frameworks and document best practices for ...
Medical Writing Manager
Lexington, KY · Remote
$50 - $80/hr
Remote micro1 is engaging Medical Writers / Clinical Document Authors to participate in a customer ... Collaborate with project leads to refine evaluation frameworks and document best practices for ...
Bilingual Construction Manager
Louisville, KY · Remote
$100K - $150K/yr
Project types could include equipment installations, facility construction, site work, process ... Eligible full-time and part-time members will be offered medical, dental, vision insurance ...
Bilingual Construction Manager
Louisville, KY · Remote
$100K - $150K/yr
Project types could include equipment installations, facility construction, site work, process ... Eligible full-time and part-time members will be offered medical, dental, vision insurance ...
Bilingual Construction Manager
Louisville, KY · Remote
$100K - $150K/yr
Project types could include equipment installations, facility construction, site work, process ... Eligible full-time and part-time members will be offered medical, dental, vision insurance ...
Quick apply
Bilingual Construction Manager
Louisville, KY · Remote
$100K - $150K/yr
Project types could include equipment installations, facility construction, site work, process ... Eligible full-time and part-time members will be offered medical, dental, vision insurance ...
Medical Writing Manager
Louisville, KY · Remote
$50 - $80/hr
Remote micro1 is engaging Medical Writers / Clinical Document Authors to participate in a customer ... Collaborate with project leads to refine evaluation frameworks and document best practices for ...
Medical Writing Manager
Louisville, KY · Remote
$50 - $80/hr
Remote micro1 is engaging Medical Writers / Clinical Document Authors to participate in a customer ... Collaborate with project leads to refine evaluation frameworks and document best practices for ...
Remote Medical Device Project Manager information
What does a remote medical device project manager do?
A Remote Medical Device Project Manager oversees the planning, execution, and completion of projects related to medical devices, all while working remotely. They coordinate cross-functional teams, manage timelines and budgets, ensure regulatory compliance, and communicate with stakeholders to keep projects on track. Their role is crucial for ensuring that new medical devices are developed efficiently and safely, meeting both company goals and industry standards.
What are the key skills and qualifications needed to thrive as a remote medical device project manager?
To thrive as a Remote Medical Device Project Manager, you need strong project management skills, a background in engineering or life sciences, and knowledge of medical device regulations, often supported by a PMP certification or similar credential. Familiarity with project management tools like Microsoft Project, collaboration platforms, and regulatory submission systems (such as FDA eCTD) is commonly required. Exceptional communication, leadership, and problem-solving abilities help in leading cross-functional remote teams and managing stakeholders. These skills are crucial for ensuring regulatory compliance, timely product development, and effective coordination in a dispersed work environment.
What are some common challenges faced by remote medical device project managers, and how can they be addressed?
Remote Medical Device Project Managers often face challenges such as coordinating cross-functional teams across different time zones, maintaining clear communication with stakeholders, and ensuring regulatory compliance from a distance. These challenges can be addressed by establishing regular virtual meetings, using project management tools to track progress, and implementing standardized documentation practices. Building strong relationships with team members and fostering an open communication culture are also key to overcoming these hurdles and ensuring project success.
What is the difference between Remote Medical Device Project Manager vs Remote Medical Device Quality Assurance Specialist?
| Aspect | Remote Medical Device Project Manager | Remote Medical Device Quality Assurance Specialist |
|---|---|---|
| Certifications | PMP, CAPM, or equivalent project management certifications | ISO 13485 Lead Auditor, CQE, or similar quality assurance certifications |
| Work Environment | Oversees project timelines, teams, and deliverables remotely within medical device companies | Ensures compliance, audits, and quality processes remotely in medical device manufacturing or development |
| Employer & Industry Usage | Used by medical device firms managing product development projects remotely | Common in companies focusing on quality standards and regulatory compliance remotely |
The Remote Medical Device Project Manager focuses on managing project timelines, teams, and deliverables remotely, ensuring successful product development. In contrast, the Remote Medical Device Quality Assurance Specialist concentrates on maintaining quality standards, conducting audits, and ensuring regulatory compliance remotely. Both roles require specialized certifications and are vital in the medical device industry, often working in similar remote environments but with distinct responsibilities.
What are popular job titles related to Remote Medical Device Project Manager jobs in Kentucky?
For Remote Medical Device Project Manager jobs in Kentucky, the most frequently searched job titles are:
What job categories do people searching Remote Medical Device Project Manager jobs in Kentucky look for?
The top searched job categories for Remote Medical Device Project Manager jobs in Kentucky are:
- Medical Device Sales Associate Territory Account Manager
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What cities in Kentucky are hiring for Remote Medical Device Project Manager jobs?
Cities in Kentucky with the most Remote Medical Device Project Manager job openings:
Full-time
Medical, PTO
Posted 5 days ago
Job description
What You'll Do:
- Assist with the development and modification of department SOPs and work instructions
- Assist with training new Biostatistics employees; mentor and assist junior level Biostatisticians
- Develop study bids and changes in scope for Biostatistics tasks in response to prospective client’s request for proposals (RFPs)
- Attend and present the Biostatistics study execution tasks at capabilities presentations.
- As the lead Biostatistician on the studies to which you are assigned, perform, or oversee the following tasks:
- Act as primary statistical contact for internal and external project team members
- Manage projects to ensure statistics tasks are performed within the entire project timeline. Keep Biostatistics management aware of changes to project timelines
- Proactively identify and communicate changes in scope to the clinical project manager and Biostatistics management
- Review case report forms (CRFs) and completion instructions
- Give input to database design and data edit considerations necessary to collect and clean data
- Develop or review Interim Analysis Plans (IAPs) and Statistical Analysis Plans (SAPs) as needed per the protocol
- Develop or review program specifications – SDTM and ADaM dataset specifications and mock tables, listings, and figures (TLFs) – needed to perform the analysis defined in the IAP/SAP
- Perform the statistical analysis by independently programming derived datasets and TLFs and validate the developer’s corresponding programs per department SOPs
- Review programming of other team members
- Develop or review statistical methods and results sections of statistical reports, clinical study reports (CSRs), or publications
- Plan and design clinical studies, including:
- overall study design development
- outcome / endpoint determination
- power analysis / sample size estimation reports
- randomization and blinding procedures development
- statistical methods section development in the protocol
- Develop or review Randomization Plans, and randomization programs or lists
- Carry out all activities according to CTI SOPs and project-specific conventions within the framework of Good Clinical Practice (GCP) / International Conference on Harmonization (ICH) guidelines
- Rely on instructions and Biostatistics SOPs to ensure timely, standard, quality deliverables to customers
- Maintain accurate records of all work performed and ensure all relevant statistics documents are filed in the eTMF per the project-specific eTMF Plan
- Provide input to and participate in departmental meetings
What You'll Bring:
- At least 4 years of related biostatistics experience in either a pharmaceutical or CRO environment or other relatable statistical experience
- Master’s degree in Biostatistics, Statistics, or related field
- CDISC, SDTM, and ADaM dataset mapping experience
- BLA/NDA Submission experience; regulatory representation (i.e., meeting preparation/attendance, follow-up with regulatory communication) preferred
- Therapeutic experience in transplantation, autoimmune diseases, kidney and liver disease, oncology and rare disease preferred
- Experience providing statistical consulting to internal/external clients preferred
About CTI
CTI Clinical Trial and Consulting Services is a global, privately held, full-service clinical contract research organization (CRO) focused on the advancement of treatments for chronically and critically ill patient populations. We assist clinical research throughout the lifecycle of development, from drug concept to commercialization. CTI is headquartered in the Greater Cincinnati, OH region with global operations in collaboration with pharmaceutical, biotechnology, and medical device firms. For more information, visit www.ctifacts.com
Why CTI?
- Advance Your Career – We support career progression through a structured mentoring program and leadership courses that provide the support needed to grow. We also value ongoing education and training through tuition reimbursement and a dedicated training department.
- Join an Award-Winning and Valued Team – We have an award-winning unparalleled culture that can be felt by our employees across 60 countries. We support a work-life balance and the importance of time with family by offering generous health benefits and vacation packages, hybrid work from home opportunities, and paid parental leave. We also encourage care for the world around us through our unique CTI Cares program.
- Make a Lasting Impact – We focus on moving medicine forward by working on treatments for chronically and critically-ill patients, who depend on us to bring life-changing therapies to market.
Important Note
In light of recent increase in hiring scams, if you're selected to move onto the next phase of our hiring process, a member of our team will reach out to you directly from an @ctifacts.com email address to guide you through our interview process. Please ensure you are applying for jobs directly on our website (www.ctifacts.com) or from our verified LinkedIn page.
Please Note
- We will never communicate with you via Microsoft Teams or text message
- We will never ask for your bank account information at any point during the recruitment process
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.