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Prometrika Llc Jobs (NOW HIRING)

Prometrika LLC

Manager, Medical Writing

Cambridge, MA · On-site

$136K - $164K/yr

PROMETRIKA is a full-service clinical research organization (CRO) with extensive experience in clinical operations, data management, biostatistics, medical writing, and pharmacovigilance. We're ...

Apply Early

Prometrika LLC

Senior Medical Writer

Cambridge, MA · On-site

$134K - $162K/yr

PROMETRIKA is a full-service clinical research organization (CRO) with extensive experience in clinical operations, data management, biostatistics, medical writing, and pharmacovigilance. We're ...

Apply Early

Prometrika LLC

Senior Clinical Data Manager

Cambridge, MA · On-site

$144K - $167K/yr

PROMETRIKA is a full-service clinical research organization (CRO) with extensive experience in clinical operations, data management, biostatistics, medical writing, and pharmacovigilance. We're ...

Apply Early

Prometrika LLC

Clinical Trial Manager

Cambridge, MA · On-site

$140K - $168K/yr

PROMETRIKA is a full-service clinical research organization (CRO) with extensive experience in clinical operations, data management, biostatistics, medical writing, and pharmacovigilance. We're ...

Apply Early

Prometrika LLC

Principal Biostatistician

Cambridge, MA · On-site

$178K - $216K/yr

PROMETRIKA is a full-service clinical research organization (CRO) with extensive experience in clinical operations, data management, biostatistics, medical writing, and pharmacovigilance. We're ...

Apply Early

Prometrika LLC

Clinical Trial Associate II

Cambridge, MA · On-site

$75K - $90K/yr

PROMETRIKA is a full-service clinical research organization (CRO) with extensive experience in clinical operations, data management, biostatistics, medical writing, and pharmacovigilance. We're ...

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Prometrika Llc information

What types of projects do clinical research professionals typically work on at Prometrika LLC, and how does this impact day-to-day responsibilities?

At Prometrika LLC, clinical research professionals are often involved in a variety of projects ranging from early-phase clinical trials to late-stage studies across multiple therapeutic areas. This diversity means that day-to-day responsibilities can include protocol development, data management, regulatory submissions, and close collaboration with cross-functional teams such as biostatistics and medical writing. The dynamic project environment encourages professionals to be adaptable and proactive, while offering the opportunity to develop a broad skill set and work closely with sponsors and investigators.

What are the key skills and qualifications needed to thrive as a Clinical Research Associate at Prometrika LLC, and why are they important?

To excel as a Clinical Research Associate at Prometrika LLC, you typically need a background in life sciences or a related field, along with clinical research experience and knowledge of Good Clinical Practice (GCP) guidelines. Familiarity with electronic data capture (EDC) systems, regulatory documentation, and trial management software is important. Strong attention to detail, organizational skills, and clear communication are vital soft skills for effectively coordinating studies and collaborating with research teams. These competencies ensure compliance, data integrity, and successful execution of clinical trials.

What is the difference between Prometrika Llc vs Data Analyst?

AspectPrometrika LlcData Analyst
Required CredentialsBachelor's degree in related field, relevant certificationsBachelor's degree in statistics, mathematics, or related field; certifications like CAP or Microsoft Certified Data Analyst
Work EnvironmentOffice-based, collaborative team setting, healthcare or marketing industriesOffice or remote, data-focused environment across various industries
Employer & Industry UsageHealthcare analytics, marketing research, consulting firmsBusiness, finance, healthcare, technology sectors

Prometrika Llc and Data Analyst roles often require similar educational backgrounds and certifications. While Prometrika Llc may focus on healthcare or marketing analytics, Data Analysts work across diverse industries. Both roles involve data collection, analysis, and reporting, but Prometrika Llc may have more industry-specific tools and client-focused projects.

What is Prometrika LLC and what services do they provide?

Prometrika LLC is a full-service clinical research organization (CRO) that offers support to pharmaceutical, biotechnology, and medical device companies. They specialize in clinical trial management, data management, biostatistics, regulatory affairs, medical writing, and pharmacovigilance. Prometrika helps sponsors bring their products to market by managing and executing clinical studies from early-phase through post-marketing. Their team provides expertise in complex study designs, regulatory compliance, and project management to ensure high-quality research outcomes.
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Prometrika Llc jobs near you
Project Manager & DMC Coordinator

Project Manager & DMC Coordinator

Prometrika LLC

Cambridge, MA • On-site

$114K - $144K/yr

Full-time

Posted 2 days ago

Be an early applicant

Job description

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.