Documentation Project Manager Jobs in Middleton, MA

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.

Under the direction of Imaging Operations/Project Management Leadership this position is responsible to work with sponsors to manage timelines, deliverables, and resources, liaise with the appropriate staff to complete work as detailed in the client's contract and/or work order, and to effectively communicate project status and escalating issues with all internal and external stakeholders.

• Create and execute project work plans and revise as appropriate to meet changing needs and requirements
• Identifies resources needed and assigns individual responsibilities
• Manages day-to-day operational aspects of a project
• Review deliverables prepared by team before passing to client
• Track clinical trial projects, schedule site trainings, and maintain study details, questionnaires, logs, and checklists
• Set up the clinical trial start-up and close-out procedures
• Maintain TMF and ensure project documents are complete, current, and stored appropriately
• Prepare project status to client and management; generate weekly status, site, and enrollment reports
• Complete quality control documentation according to standard operating procedures
• Assist in the development of study documentation and perform quality controls
• Perform CTIS function to quality review the project images as needed
• Review and approve training materials for imaging site personnel
• Review and approve the site evaluation documentation
• Project manage early phase clinical trials
• Assist a tenured Project Manager with registration clinical trials
• Mentor and assist in the training of project associates
• Perform other duties as assigned by supervisor

• Bachelor's degree in a science or health-related field (or equivalent combination of education and professional experience)
• Minimum of 2 years industry (clinical CRO or pharmaceutical industry) experience is required
• Minimum of 2 years in medical imaging preferred
• Knowledge of Good Clinical Practice (GCP), Quality Assurance/Compliance in a clinical trials setting is required
• Exposure to electronic data capture for clinical trials required

• Execute project deliverables for imaging studies in clinical trials in accordance with project scope of work and within sponsor specified timelines;
• Manage day-to-day operational aspects of a clinical imaging projects;
• Assist in preparation and adherence to imaging trial documents i.e. Image Review Charter, Imaging Manual, Data Transmittal Forms, etc;
• Ensure project documents are complete, current, and stored appropriately;
• Manage key project documents/processes, i.e. Project Management Plan, Communication Plan, Escalation Plan, Risk Management Plan and appropriate Clinical Trial Management System (CTMS);
• Identify resources needed and assign individual responsibilities;
• Identify out of scope requests and work with appropriate team(s) to revise the work order to meet changing needs and requirements;
• Review and manage all deliverables;
• Prepare metrics reporting for client and senior management;
• Prepare forecasting information for Finance purposes;
• Perform other duties as assigned by the Supervisor

• Bachelor's degree or equivalent certification in a health related field
• Knowledge of Good Clinical Practice (GCP), Quality Assurance/Compliance in a clinical trials setting is required
• Knowledge of key project management documents and tools a must
• Prior experience with different EDC systems required
• Proficiency in MS Office and internet applications required
• Minimum of 3 to 5 years of experience in the clinical trials industry required
• Minimum of 2 years of experience in medical imaging in a clinical trial environment required
• Experience managing global Phase III clinical trials with imaging components strongly preferred
• PMP certification a plus

• Execute project deliverables for imaging studies in clinical trials in accordance with project scope of work and within sponsor specified timelines;
• Manage day-to-day operational aspects of a clinical imaging projects;
• Assist in preparation and adherence to imaging trial documents i.e. Image Review Charter, Imaging Manual, Data Transmittal Forms, etc;
• Ensure project documents are complete, current, and stored appropriately;
• Manage key project documents/processes, i.e. Project Management Plan, Communication Plan, Escalation Plan, Risk Management Plan and appropriate Clinical Trial Management System (CTMS);
• Identify resources needed and assign individual responsibilities;
• Identify out of scope requests and work with appropriate team(s) to revise the work order to meet changing needs and requirements;
• Review and manage all deliverables;
• Prepare metrics reporting for client and senior management;
• Prepare forecasting information for Finance purposes;
• Provide mentoring and support to other Project Managers as needed;
• Perform other duties as assigned by the Supervisor

• Bachelor's degree or equivalent certification in a health related field
• Knowledge of Good Clinical Practice (GCP), Quality Assurance/Compliance in a clinical trials setting is required
• Knowledge of key project management documents and tools required
• Prior experience with different EDC systems required
• Proficiency in MS Office and internet applications required
• Minimum of 5 to 10 years of experience in the clinical trials industry required
• Minimum of 5 years of experience in medical imaging project management in a clinical trial environment required
• Experience managing global Phase III clinical trials with imaging components required
• Prior experience supporting FDA and sponsor audits required
• PMP certification a plus

• Proficiency in MS Office and internet applications
• Service-oriented approach, flexible, and proactive toward adapting to client needs
• Ability to manage project activities with diverse group and individuals with little supervision
• Must have superior attention to detail including excellent oral and written communication skills.
• Must have the ability to work independently, multitask, and meet critical timelines under pressure
• Must have strong time management and organization skills
• 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
• Maintain strict confidentiality of sensitive data, records, files, conversations, etc.
• Must be self-motivated and able to grasp new concepts quickly
• Ability to prioritize workload to the changing needs of the day-to-day business
• Ability to understand technical research protocols and successfully lead within the research environment

• 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

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: 15 - 20% (domestic and international)