Reports to: Associate Director (AD), Clinical Operations

General Purpose:

The COM (Clinical Operations Manager) is responsible for oversight of MMRC trial-specific activities/communications on assigned clinical trial programs and any other key programs related to Clinical Operations at the MMRC; confirms operational strategies aligned with MMRC Operations departmental goals and objectives; and provides leadership to the network of MMRC MMPMs (multiple myeloma project managers), industry PMs and CRO PMs. The COM serves as a role model and mentor to both external and internal MMRC constituents and ensures a productive and professional work environment within and throughout the department.

Responsibilities:

Business and Teamwork

Responsible for the overall day-to-day project management communications amongst MMRC network sites and industry/CRO partners associated with company-sponsored MMRC trials. Conducts MMRC feasibility activities and confirms site participation on selected MMRC trials. Oversees the coordination and communications associated with trial meeting planning and drives trial execution according to MMRC start up and enrollment benchmarks.

• Develops expertise surrounding MMRC site-specific clinical trial approval map/processes which clearly describe each member institution’s internal submission pathway including: internal regulatory procedures, budget procedures and associated timing for clinical trial start up through first patient, first dose. Informs industry partner of realities at MMRC academic centers using the process map to educate and set realistic expectations.

• Maintains a Consortium-wide landscape of ongoing and upcoming MMRC trials at each member institution. Functions as the key liaison to MMPM member site staff for cultivation of IST (Investigator-Sponsored Trial) concepts and engagement in MMRC clinical trials activities. The COM co-owns MMRC’s annual objective of delivering 3-4 new IST concepts to MMRC’s Protocol Quality Assurance Team (CTCMRT).

• Provides ongoing education and training for the MMPM team via routine communications, monthly MMPM teleconference meetings, and follows up on action items as appropriate to support their efforts at the MMRC member institution.

• Assists the AD Operations with the MMPM Annual Summit.

• Visits MMRC sites at least annually and becomes acquainted with MMPM supervisor and other key internal MMRC site-champions as provided by the MMPM.

• Monitors MMRC’s CTMS (Clinical Trial Management System) data entry to ensure up-to-date information and recommends upgrades to increase efficiency and outputs from this MMRC electronic system. Directly oversees the correction of questionable data, omissions or errors in CTMS with input from the MMPMs. In collaboration with the AD of Operations, conducts analysis of the CTMS for reporting purposes (metrics, scorecard, messaging).

• Collates and provides the bi-monthly Operations report for review by AD Operations. Works closely with the AD Operations and IST PMs to ensure accuracy of start up and enrollment data included in this broadly circulated report.

• Provides written updates to AD Operations for the monthly report to the CEO.

• Supports development of Operations-centered power point slides for metrics communications and messaging including status of MMRC trials and other programs such as the Longitudinal Study requested by the AD Operations, VP Clinical Development/EC.

• Provides sponsor/CRO orientation to MMRC Operations and agrees to trial timelines and role expectations during protocol development phase, or during immediate start-up if trial is already ongoing.

• Maintains positive working relationship with Trial Sponsor PM and reports issues with CRO PMs if necessary. Provides recommendations for resolution of issues; visits industry Sponsor PMs (and if possible, CRO PM) as soon as possible once MMRC trial participation is confirmed. Where possible, attend Sponsor Investigator meetings to obtain overall expectations of trial conduct/timelines.

• Follows internal electronic filing guidelines and maintains accurate files and updated process documents in the Consortium Operations drive located on the J drive.

General requirements and Qualifications

• University undergraduate degree (BA, BS) with science concentration or experience in research or RN or BSN or Pharmacy degree
• 5-10 Years relevant clinical research experience, preferably at pharma or biotech company or CRO, preferably a Project Manager Level I or II with study coordinator experience
• Strong experience and knowledge within clinical trial and drug development organizations
• Study coordinator experience is highly desirable
• Strong communication and organizational skills including Microsoft Office with particular focus on Excel and PowerPoint 
• Experience with Database/data metrics handling is highly desirable
• Strong influencing skills
• Strong ability to build and maintain relationship with investigators at MMRC member sites and with pharma/biotech companies for business relations
• Strong problem solver
• Good technical savvy
• Good presentation skills
• Preferably on-site but with ability to work effectively remotely