Immediate Need for an Imaging Project Manager with a CRO. This is a full time permanent position.
-Must have Imaging Core Lab experience and come from a CRO experience along with oncology work
- Candidates need to be client facing and applicable on Phase III trials (mostly oncology)
- Remote capabilities or they can sit out of Boston, MA or Scottsdale, AZ
- Minimum of 5 years' experience
Responsibilities:
- 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
EDUCATION AND EXPERIENCE:
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
SKILLS
Service oriented approach, flexible and proactive towards adapting to sponsors’ needs
- Ability to manage project activities with diverse groups and individuals
- Must have superior attention to detail and excellent oral and written communication skills
- Self-driven, ability to get the job done with little supervision, can-do positive attitude
- Ability to excel in a team environment
- Must have the ability to work under pressure with multiple competing priorities
- Must have strong time management, and organizational skills. Prioritizing workload to the changing needs of the day to day business is also a critical skill.
- 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
- Possess the ability to understand research projects and successfully lead within the clinical trial environment