Project Manager & DMC Coordinator

Salary Range: $ To $ Annually

This position has two main areas of responsibilities. The first is to perform project management activities for assigned projects. The second is to be responsible for the operational aspects of the set-up and management of the Data Monitoring Committee activities. The Project Manager will have the following responsibilities as assigned by the Director of Project Management:

• Oversee multiple projects simultaneously
• Coordinate project organization, implementation, management, and financial activities for non-DMC projects between all functional areas at PROMETRIKA and with the client using PROMETRIKA’s Project Manual and procedures, as available
• Prepare the project plan including timelines and resource requirements using these tools to measure actual project progress.
• Work with PROMETRIKA study team and client to implement solutions to problems with study timelines, schedules, resources, budgets, etc.
• Along with internal finance project management, develop, evaluate and manage project budget against project milestones for assigned projects to ensure profitability.
• Track and report significant changes in scope of work and recommend change of scope orders to management, when appropriate.
• Coordinate project team meetings (prepare agenda and meeting minutes) for assigned projects if stated in the contract.
• Prepare project status reports for assigned projects to the client, on a predetermined schedule if stated in the contract.
• Participate in all formal interactions with the client on a pre-determined frequency
• Conduct other project management tasks as assigned

• Serve as primary point of contact to the sponsor regarding assigned DMC projects
• Act as the main point of contact between the DMC members and the sponsor
• Assume primary responsibility for ensuring adherence to the DMC charter by all involved parties. Ensure that all requests made by the sponsor to deviate from the charter are documented in writing
• Assure that project tasks and deliverables are properly executed and tracked according to defined budgets and timelines
• Assist in the development of the DMC data preparation timeline
• Assess the impact of added efficiencies/process improvements introduced specifically for the DMC group within Biostatistics and Programming Department
• Work with the Associate Director, Biostatistics and Leader of DMC Group as well as the Client Relations Department on implementing efficiencies into budgets for bids for new work
• Identify DMC members and manage the process of contract development and execution for DMC members
• Manage payment of honoraria to the DMC members and maintain tracking of payments in accordance with the Sunshine Act if requested by sponsor
• Track pass-through costs
• Ensure that all sponsor and DMC member requests to PROMETRIKA align with the PROMETRIKA Statement of Work with the sponsor
• Poll the DMC members and the Sponsor for potential meeting dates. Bring quorum issues to the attention of the sponsor and facilitate discussions between members and the sponsor to identify a solution
• Track and accommodate DMC member requests as they relate to the meeting
• Set up and host the teleconference/web conference if the meeting is held virtually, or book meeting location and coordinate relevant logistics if the meeting is held in-person. Ensure all details are properly communicated to all relevant parties.
• Confirm Data Monitoring Report contents with the sponsor and ensure timely receipt of all materials. Compile all documents for the assembly of the Data Monitoring Report
• Provide the Data Monitoring Report in accordance with the timeline as stipulated in the DMC charter
• Build the tables, listings, and figures (TLF) pdf document and Table of Contents in accordance with the TLF shell as provided by the sponsor
• Develop and QC the meeting agenda and cover letter
• Attend DMC meetings and take minutes of the DMC meetings
• Circulate the draft minutes and recommendation to the appropriate stake holders and finalize the minutes and recommendation in accordance with the DMC charter
• All other coordination tasks as necessary and appropriate

• Collaborate with Associate Director, Biostatistics and Leader of DMC Services to develop and maintain documents, tools, and forms, standardizing the formatting of existing templates both in the DMC group and within the wider Biostatistics/Statistical Programming department
• Responsible for first draft of most documents for the DMC group, such as standard TLF shells and report shells
• Coordinate with Quality Assurance and Biostatistics to ensure that SOPs cover DMC work without hindering potential efficiencies and work with management to establish new SOPs where needed
• Other responsibilities as assigned

• Bachelor’s degree in Computer Science, Mathematics, Statistics, Life Sciences or a related field is required or equivalent combination of education, skills and…