Imaging Endpoints
Website:
imagingendpoints.com
Job details:
Imaging Endpoints (IE) is an Imaging Technology and Imaging Clinical Research Organization (iCRO). We are passionately focused on our vision to Connect Imaging to the CureTM. Everything we do is aligned with this singular purpose. We work every day excited to advance imaging science, technology, and services to bring curative technologies to humankind. We have supported many of the most impactful new drug approvals in oncology, and we are seeking the most talented individuals globally that are passionate in their desire to assist us in our mission to customize each clinical trial’s imaging to optimize the opportunity to demonstrate efficacy.
Imaging Endpoints is based in Scottsdale, Arizona, with offices in Cambridge, Massachusetts; London, UK; Leiden, Netherlands; Basel, Switzerland; Hyderabad, India and Shanghai, China. We are an affiliate of HonorHealth, one of the largest healthcare systems nationally, and Scottsdale Medical Imaging Limited (SMIL/RadPartners), the largest private radiology group in the United States. We are recognized as the world’s largest and most preeminent iCRO in oncology.
The QMS Document Management Specialist / QMS Document Management Specialist II / Senior QMS Document Management Specialist is primarily responsible for assisting Compliance and Regulatory Affairs management in executing day-to-day tasks associated with managing, maintaining, and continually improving Imaging Endpoints’ document management system to meet quality and regulatory requirements.
The QMS Document Management Specialist / QMS Document Management Specialist II / Senior QMS Document Management Specialist is a compliance and solutions oriented individual; facilitating timely and compliant document management decision making and providing regulatory support. This individual is instrumental in achieving business and stakeholder needs with respect to document management principles and practices.
QMS DOCUMENT MANAGEMENT SPECIALIST
RESPONSIBILITIES
- Leads the efforts in managing and oversight of the companywide electronic document management system (eDMS) and provides administrator role support.
- Responsible for maintaining and updating eDMS system and workflow changes.
- Responsible for eDMS configuration and workflow development for QMS documents.
- Responsible to implement workflows for electronic document management, including authoring, collaboration, publication, storage, and retrieval of documents.
- Develop training program and material related to eDMS.
- Manage electronic QMS records within the eDMS including, job descriptions, personal CVs,
- SOPs, organizational charts etc.
- Manage electronic training documents and develop training reporting processes within the eDMS.
- Responsible for creating and fostering mutually beneficial intradepartmental, cross-functional and organizational relationships to drive compliance to eDMS QMS requirements.
- Interface with Compliance and Regulatory Affairs management to implement quality system strategies and plans to facilitate continuous improvement of the QMS regarding document management initiatives.
- Develops SOPs and controls related to GxP document management.
- Assist Compliance and Regulatory Affairs management during Internal Audits, Sponsor Audits or
- Regulatory Inspections as related to QMS related eDMS documentation preparedness.
- Assist in establishing and reporting quality metrics related to document management.
- Act as the primary contact for the IE eDMS change management program. Manage and report on the change management process and activities related QMS document management and control.
- Ensure proper control, retention, and archival of QMS documents per regulatory requirements.
- Assist in establishing, implementing and maintaining QA procedures and controls to develop an effective, efficient and compliant IE QMS change management program.
- Perform other duties as assigned by Compliance and Regulatory Affairs management.
- Act in a supporting role to other QMS Specialist positions.
EDUCATION AND EXPERIENCE
- Bachelor’s degree in pharmaceutical sciences or other related scientific discipline.
- Minimum five (5) years of experience in a regulated industry with at least three (3) years of experience in eDMS management and administration.
- Subject matter expertise in a commercial eDMS system, with preferred experience as a MasterControl Administrator or equivalent.
- Imaging Core Lab and/or CRO experience preferred.
- Knowledge and understanding of Good Clinical Practices (ICH E6 GCP), Good Documentation
- Practices (GDP) and Quality Management Systems (QMS).
- Proficiency in MS Office and internet applications
QMS DOCUMENT MANAGEMENT SPECIALIST II
RESPONSIBILITIES
- Leads the efforts in managing and oversight of the companywide electronic document management system (eDMS) and provides administrator role support.
- Responsible for maintaining and updating eDMS system and workflow changes.
- Responsible for eDMS configuration and workflow development for QMS documents.
- Responsible to implement workflows for electronic document management, including authoring, collaboration, publication, storage, and retrieval of documents.
- Develop training program and material related to eDMS.
- Manage electronic QMS records within the eDMS including, job descriptions, personal CVs, SOPs, organizational charts etc.
- Manage electronic training documents and develop training reporting processes within the eDMS.
- Responsible for creating and fostering mutually beneficial intradepartmental, cross-functional and organizational relationships to drive compliance to eDMS QMS requirements.
- Interface with Compliance and Regulatory Affairs management to implement quality system strategies and plans to facilitate continuous improvement of the QMS regarding document management initiatives.
- Develops SOPs and controls related to GxP document management.
- Assist Compliance and Regulatory Affairs management during Internal Audits, Sponsor Audits or
- Regulatory Inspections as related to QMS related eDMS documentation preparedness.
- Assist in establishing and reporting quality metrics related to document management.
- Act as the primary contact for the IE eDMS change management program. Manage and report on the change management process and activities related QMS document management and control.
- Ensure proper control, retention, and archival of QMS documents per regulatory requirements.
- Assist in establishing, implementing and maintaining QA procedures and controls to develop an effective, efficient and compliant IE QMS change management program.
- Perform other duties as assigned by Compliance and Regulatory Affairs management.
- Act in a supporting role to other QMS Specialist positions.
EDUCATION AND EXPERIENCE
- Bachelor’s degree in pharmaceutical sciences or other related scientific discipline.
- Minimum five (5) years of experience in a regulated industry with at least four (4) years of
- experience in eDMS management and administration.
- Subject matter expertise in a commercial eDMS system, with preferred experience as a MasterControl Administrator or equivalent.
- Imaging Core Lab and/or CRO experience preferred.
- Knowledge and understanding of Good Clinical Practices (ICH E6 GCP), Good Documentation
- Practices (GDP) and Quality Management Systems (QMS).
- Proficiency in MS Office and internet applications
SKILLS
- Superior attention to detail, particularly in written documentation
- Service oriented approach, flexible, and proactive
- Self-driven, ability to get the job done with little supervision, can-do positive attitude
- Ability to excel in a team environment
- Ability to work in strict compliance with all procedures, rules, and regulations
- Ability to manage projects and deliverables with a high level of accuracy and completeness.
- Maintain strict confidentiality of sensitive data, records, files, conversations, etc.
- Must be self-motivated and able to grasp new concepts quickly
- Excellent hands-on computer skills with thorough knowledge of Microsoft Office to include Word, Excel and Power Point.
IMAGING ENDPOINTS’ TEAM CHARACTERISTICS
- Passion to Connect Imaging to the CureTM and pursue a meaningful career by improving the lives of cancer patients through imaging
- Strong desire to be part of a dynamic, global team working closely together and growing year after year in a rewarding environment to help humanity through imaging
- Commitment and caring for our fellow team members, their families, and the communities IE serves - see more information about Caring Endpoints at https://caringendpoints.org/
- Integrity and high ethical standards; we always do the right thing
- High intellect and ingenuity; we enjoy solving problems, finding a better way, and the challenge of making a difference by improving lives
- Structured, organized, detail-oriented, and self-motivated; we approach each day with a detailed plan and excitement to accomplish the day’s objectives while striving to improve ourselves and IE
- Accountable; we do what we say and communicative effectively to meet deadlines; we enjoy advancing clinical trials, helping patients, and celebrating success
- High standard for excellence; we proof our own work, hold high standards for ourselves and our team, and always prioritize quality above all else
PHYSICAL REQUIREMENTS
While performing the duties of this job, the employee is regularly required to use hands to finger, handle, or feel; reach with hands and arms and talk and hear. The employee is frequently required to sit. Specific vision abilities required by this job include close vision, color vision, ability to adjust focus.
Travel: Estimated up to 10% travel (domestic and international)
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