Clinical Research Project Manager

Location
Rockville, Maryland
Posted
Jun 22, 2018
Closes
Jun 30, 2018
Industry
Research
Hours
Full Time

The EMMES Corporation, established in 1977, is a privately-owned Contract Research Organization (CRO). Headquartered in Rockville, Maryland, Emmes employs over six hundred staff worldwide with offices located in Frederick, Maryland, Vancouver, Canada and Bangalore, India. Ranked as a top area workplace of choice by the Washington Post, Emmes fosters an environment of collaboration, professional growth, and exceptional work life balance.

Our studies impact public health initiatives on a global scale occurring in more than sixty countries spanning across six continents. We offer statistical support for the entire process of clinical trials from study design and protocol development through data analysis and manuscript generation. Emmes is seeking three Clinical Research Project Managers, located in either our Rockville or Frederick office

Project

This position will support one or more studies within the Vaccine and Infectious Disease (VID) research team that provide data management and statistical support for more than 100 clinical research studies, including single-site and multi-center studies at domestic and international sites. The VID group supports infectious disease research across a wide range of disease areas, including: Malaria, Tuberculosis, Influenza, Ebola, MRSA, STI and Enteric pathogens, and emerging infectious diseases. VID supports Phase 1-4 clinical trials investigating vaccines and treatments for bacterial, viral, and parasitic agents, as well as epidemiological studies. Primary services include statistical design and analysis; bioinformatics support; implementation of Emmes’ proprietary software for electronic data collection, data management, and electronic specimen tracking; preparation of study-related materials and web site development; generation of safety, regulatory, and final reports and manuscripts; clinical site training, assessment, and technical assistance; and study communication and collaboration.

The Project Manager is responsible for overseeing all study-specific data management and statistical activities within their study portfolio in accordance with Good Clinical Practices and other relevant guidelines. The Project Manager ensures that timelines are met and deliverables are of high quality. The Project Manager works closely with the statistician to lead a multidisciplinary project team through the lifecycle of the clinical study, from protocol development through final reporting. The Project Manager is instrumental in the review of data management deliverables, including data collection forms, electronic case report forms, data integrity checks, manuals of procedure, and data collection guidelines. The Project Manager is the main point of contact with the study sponsor and clinical site investigators.

Responsibilities

  • Key role as team leader in project planning, implementation, and problem solving
  • Track study milestones and deliverables, ensure high quality of deliverables
  • Liaise with the study sponsor and the collaborating investigators to initiate and support clinical protocols
  • Oversee development of the electronic case report forms and the study database
  • Review data edit checks and queries produced by the study data manager
  • Provide critical review of study materials, including the study protocol, manual of procedures, and statistical analysis plan
  • Oversee generation of study reports (safety, regulatory, and final) and contribute to manuscripts
  • Utilize project management tools and practices to complete tasks and report activities
Experience

    Bachelor’s degree in a scientific discipline or equivalent experience Minimum 4-6 years of experience in clinical research, including at least 2 years of data management experience Knowledge of GCP and HSP regulations Prior experience in infectious disease research is preferred Strong data management skills; experience with CRF design, EDC systems, or other web-based data collection system Prior experience in mentoring/training new or junior staff is a plus Excellent oral and written communication skills with the ability to effectively communicate and coordinate with internal and external clients and colleagues Personable and able to work well as part of a team Skills in prioritization, problem solving, organization, decision making, time management and planning

Emmes has an outstanding benefits package including: generous tuition reimbursement, professional development and training programs

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The EMMES Corporation is an equal opportunity affirmative action employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability, protected veteran status, genetic information, age, or other legally protected characteristics.

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