Job Description
Job Description
Job Description
Description:
THIS IS AN ENTRY LEVEL POSITION
JOB SUMMARY:
The Associate Clinical Project Manager (ACPM) will provide direct support to Clinical Project Mangers (CPM) and Senior Clinical Project Managers (Sr. CPM) to manage day-to-day operational and tactical aspects of the studies managed by the business. The ACPM is responsible for supporting CPM team by assisting with requests received from sites, trial sponsors, and other stakeholders that use MMI’s services and systems. The ACPM collaborates losely with his/her supervisor to establish working priorities and ensure that client-commitments are met satisfactorily.
DUTIES AND RESPONSIBILITIES:
- Project Support for Trials and Studies
- Internal Support and Delivery
- Provides routine and daily support to CPMs
- Collaborates closely with CPMs to establish working priorities and ensure that commitments are met
- Assists CPMs with managing and monitoring project health
- Provides support in preparation for regulatory and project / sponsor audits
- Prepares standard non-analysis project reports per the study contract and departmental schedule (ex. inventories, IQS Reports, etc.)
- Prepares presentations, training materials, and project-specific site binders for CPMs to review
- Assists CPMs with quick turn project management (ex. Eligibility Studies)
- Creates and maintains communication plan and contacts for projects (ex. report distribution lists)
- Performs CPM functions, as requested
- Provides short-term/temporary fill-in or back-up support for CPMs, as needed
- Site & Sponsor/CRO (External Support)
- Manages site initiation process under CPM’s supervision
- Coordinates, schedules, and delivers training for investigator sites
- Maintains requisite documentation of all project-specific training
- Provides supplies to investigator sites (ex. calibration markers) and fulfills requests for refills
- Assists in investigation, delivery, and resolution of discrepant data and queries to investigator sites and/or trial sponsors
- Provides helpdesk support to Sponsor/CRO/Investigator site users of MMI systems
- Respond to support requests from Investigator sites and client users of MMI systems
- Creates new user accounts and maintains documentation for users of MMI systems, as applicable
- Maintains the necessary documentation for support and troubleshooting
- Assists with administering client satisfaction surveys and documenting feedback
General
- Effectively communicates relevant project information to the organization
- Possesses knowledge of each client’s business, organization, and objectives
- Tactfully communicates sensitive information
- Works across the organization to share lessons learned and best practices
- Lends expertise/assistance to internal teams including other departments
Requirements:
EDUCATION AND EXPERIENCE:
- Bachelor’s degree in research, medical, or science-related discipline or comparable work history (significant / relevant / extensive professional
experience may also be acceptable) - Minimum of 1 year research experience, preferably clinical research and/or multi-center trials
SKILLS REQUIRED:
- Strong written and oral communication
- Strong customer service skills
- Extremely responsive to requests and correspondence, and follow issues through to closure
- Experience working in a team oriented, collaborative environment
- Ability to communicate technical information in a business-friendly manner
- Ability to manage multiple concurrent tasks, determine relative importance, and prioritize
- Understands the need for complete documentation and good organizational skills
- Ability to plan, facilitate, and conduct meetings
- Willing to lead training and deliver presentations – in person, by phone, or via webinar
- High aptitude for learning new tools and skills quickly
- Possesses good computer skills, preferably having trained or supported others on software
- Experience with standard tools, including but not limited to Microsoft Office (Word, Excel, PowerPoint, etc.)
- Experience with clinical research
PLUSES:
- Working knowledge of conventional clinical imaging modalities (XR, CT, MR, and others)
- Experience working on global studies
- Knowledge and understanding of the FDA 510(k) / PMA regulatory pathways
Job Tags
Contract work, Temporary work,