Project Manager & DMC Coordinator

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

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:

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.
• 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

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
• 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

DMC Group Infrastructure Responsibilities:

• 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

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
• Fluent in spoken and written English
• 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.

The salary range for this position here noted is representative of a good faith estimate of all experience levels for this position. 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.