Project Manager & DMC Coordinator

About the role

PROMETRIKA is a full-service clinical research organization (CRO) with extensive experience in clinical operations, data management, biostatistics, medical writing, and pharmacovigilance. We’re driven by our passion for the human aspect of our work and our compassion for the people whose lives have been improved by the innovations we help bring to market. Our clients include national and international biopharmaceutical and medical device companies of all sizes.

Responsibilities

• General Project Management Responsibilities:

  • 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.
  • 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
  • Cook up 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

• DMC Project Management Responsibilities:

  • 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
  • Afford 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
  • Afford assurance that project tasks and deliverables are properly executed and tracked according to defined budgets and timelines
  • Afford assistance in the development of the DMC data preparation timeline
  • Afford assessment of the impact of added efficiencies/process improvements introduced specifically for the DMC group within Biostatistics and Programming Department
  • Afford collaboration with 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
  • Afford management of payment of honoraria to the DMC members and maintenance of tracking of payments in accordance with the Sunshine Act if requested by sponsor
  • Afford tracking of pass-through costs
  • Afford identification of DMC members and management of the process of contract development and execution for DMC members
  • Afford management of honoraria payments to DMC members and maintenance of tracking of payments in accordance with the Sunshine Act if requested by sponsor
  • Afford tracking and accommodation of DMC member requests as they relate to the meeting
  • Afford setup and hosting of the teleconference/web conference if the meeting is held virtually, or booking of meeting location and coordination of relevant logistics if the meeting is held in-person. Ensure all details are properly communicated to all relevant parties
  • Afford confirmation of 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
  • Afford development and quality control (QC) of the meeting agenda and cover letter
  • Afford attendance at DMC meetings and taking of minutes of the DMC meetings
  • Afford circulation of the draft minutes and recommendations to the appropriate stakeholders and finalization of the minutes and recommendations in accordance with the DMC charter
  • Afford other coordination tasks as necessary and appropriate

• DMC Group Infrastructure Responsibilities:

  • Afford collaboration 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
  • Afford responsibility for first draft of most documents for the DMC group, such as standard TLF shells and report shells
  • Afford coordination 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
  • Afford other responsibilities as assigned

Education

Bachelor’s degree in Computer Science, Mathematics, Statistics, Life Sciences or a related field is required or equivalent combination of education, skills and experience to perform the job

Experience

• Minimum of 5 years of experience in a clinical project management environment (CRO, pharmaceutical company, or other centralized service provider used in clinical studies)

• Minimum of 1 year of experience in the document support role

• Demonstrated experience of successfully managing or leading multidisciplinary teams

• Demonstrated experience with process improvement initiatives

Skills

• Excellent written and verbal communication skills

• Strong organizational skills, especially around scheduling and planning meetings

• Meticulous attention to detail

• Excellent time management skills

• Advanced skills in MS Office application, particularly Microsoft Word and Excel

• Ability to work independently and know when escalation is necessary

• Ability to handle multiple tasks, including rapid response in generating new documents, forms and tools

• Quick learner, self-reliant and enjoys working within cross functional teams

Physical Requirements

Incumbents generally must be able to, with or without accommodation, have the proficient use of both sensory perception/clarity and muscle control/coordination. This may include vision (near, far, color, glare control), hearing (auditory attention, sound localization), speech, strength, agility, dexterity flexibility, steadiness or reaction time.

Pay

PROMETRIKA considers several factors when extending and offer, including but not limited to the role, the function and associated responsibilities, the candidate’s work experience, education/training background and parity with current employees in the same or similar positions.