SUMMARY
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 theworld’s largest and most preeminent iCRO in oncology.
The Clinical Data Manager I / Clinical Data Manager II / Senior Clinical Data Manager / Principal Clinical Data Manager’s primary responsibilities are to lead, direct, and conduct all clinical data management activities for each assigned clinical study. Other duties include coordinating with study team members, management and clients to complete work as detailed in the client’s work order;maintain audit readiness by ensuring study related documents are in the study eTMF in a timely manner;effectively communicateproject status to internal and external stakeholders;and conduct clinical data management activities per relevant standard operating procedures and work instructions.
RESPONSIBILITIES
Serve as primary clinical data management contact for assigned clinical studies, including both internal and external stakeholdersLead clinical data management aspects of processing radiological images received for client projects in accordance with standard operating proceduresCreate and maintain data management plansLead the design and development of eCRFs to be used in the imaging analysis platform per client needs and study criteriaLead design and development of EDC and other databasesTrain applicable personnel to use data collection tools, as applicableConduct quality control review of clinical trial dataConduct review of eCRFs, reports, or listings, as applicableGenerate, track, and close queries for images, reports, eCRFs, as applicableCreate and maintain data transfer specificationsConduct data / image transfers, as applicableMonitor radiology readers for applicable on-site readsOversee generation and / or quality control review of Diagnostic and Summary ReportsLead applicable data analysis activitiesLead UAT activities for data collection and transfer systems / tools, including creating UAT Plan and Test CasesMaintain paper and / or electronic project files in accordance with standard operating proceduresEnsure compliance with all standard operating proceduresCreate applicable study specific proceduresCreate applicable study specific reportsAssist with development and versioning of clinical data management standard operating proceduresLead generation of study specific data collection tools / databasesAssist with training and mentoring of other clinical data management staffUpdate appropriate study team members and management with task, deliverable, and project statusesCreate and maintain study timelines to meet data deliverables by planning accordinglyContribute to department and company process improvementPerform other tasks as neededEDUCATION AND EXPERIENCE
Bachelor’s Degree required or equivalent combination of education and relevant work experienceAt least 3 years of prior clinical data management experience requiredIntermediate knowledge of analysis software such as SAS preferredUnderstanding of database development, especially electronic data capture systems used in clinical trialsKnowledge of Good Clinical PracticesWorking knowledge of medical terminology requiredKnowledge of clinical trials and / or healthcare industries requiredExpertise in using MS Office and internet applications requiredSKILLS
Ability to understand technical research protocols and successfully lead within the research environment.Hands-on ability to think tactically and strategicallyProficiency in MS Office and internet applicationsService oriented approach, flexible and proactive towards adapting to clients' needsAbility to manage project activities with diverse groups and individualsMust have great attention to detail and excellent oral and written communication skillsAbility to excel in a team environmentMust have the ability to multitask and work under pressureMust have strong time management and organizational skills. Prioritizing workload to the changing needs of the day-to-day business is a critical skill.Ability to assess the importance of a phone call, email, or document and take appropriate action to involve the required parties quickly and accuratelyWork precisely according to all procedures, rules, and regulationsMust maintain strict confidentiality of sensitive data, records, files, conversations, etc.Self-motivated and able to grasp new concepts quicklyIMAGING ENDPOINTS’ TEAM CHARACTERISTICS
Passion to Connect Imaging to the CureTM and pursue a meaningful career by improving the lives of cancer patients through imagingStrong 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 imagingCommitment and caring for our fellow team members, their families, and the communities IE serves - see Caring Endpoints https : / / imagingendpoints.Com / caring-endpoints /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 everyday
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 position, 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 5 - 10% travel (domestic and international)