Project Manager-Clinical Research

US-MD-Rockville
# Positions
1
Category
Always Considering

Overview

KAI Research, Inc., a wholly owned Altarum Company. KAI is a full-service contract research organization (CRO) and health research company. Since 1986, we’ve helped pharmaceutical, academic, and federal clients bring innovative drug treatments and other interventions to market. We have supported several federal clients for multiple decades and coordinated hundreds of clinical trials and epidemiological studies in a wide variety of therapeutic areas. We are seeking to hire a Project Manager to manage projects.

 

Job Summary:  

Responsible for management of clinical research, data management, and health-research projects for government or commercial organizations. With limited supervision from senior staff, acts as project team leader for research projects.

Responsibilities

Essential Duties:

Contract/Budget/Timeline Management

  • Assures contractual requirements between KAI and the client are followed and that changes are documented and appropriate departments are notified
  • Prepares internal, project-specific budgets to monitor cost and timeline performance
  • Reports to company executives on status of projects and problems related to meeting performance goals
  • Ensures tasks are completed on-time and work is of the highest quality possible
  • Performs related duties as required to ensure successful management of ongoing projects

 

Development and Maintenance of Materials/Systems/Tools

  • Oversees internal data management activities on assigned projects including data standardization efforts, management of CRF receipt and processing, database set up (EDC, LMS, CTMS, etc.), data quality control checks, etc. according to established standard operating procedures
  • Reviews project deliverables for quality and adherence to standards and procedures
  • Ensures ongoing communication with sponsors and sites on project-related issues
  • Maintains tracking tools to monitor timelines, budgets, training, enrollment, CRF processing, etc
  • Communicates status on an ongoing basis to the sponsor and to KAI management
  • Initiates corrective actions to ensure projects are completed on schedule and on budget
  • Prepares reports and listings at client request or in support of pre-established safety, investigator, and monitoring meetings.
  • Participates in meetings as appropriate
  • Maintains clinical research records and related documents
  • Develops internal SOPs and training
  • May assist in coordination of regulatory submissions as required

 

Management and Development of Team/Staff 

  • Assembles a project team and establishes team guidelines and trains team members on study-related responsibilities
  • Reports to Operations Managers on staffing resources
  • Works with senior staff to appropriately assign team members with tasks to assure successful completion of projects

 

Reports/Deliverables

  • Reviews protocols and develops plans, procedures, and source documentation to support study objectives
  • Oversees development of study-related documents by internal staff
  • Prepares reports and listings at client request or in support of pre-established safety, investigator, monitoring and status meetings
  • Reviews project deliverables for quality and adherence to standards and procedures
  • Provides support as needed in responses to Request for Proposals (RFPs)
  • Works collaboratively with monitors to ensure monitoring schedules are adhered to and that findings from visits are disclosed

 

Client Interaction/Communication (external vendors included)

  • Participates in meetings as appropriate
  • Participates in site visits as needed
  • Maintains ongoing communication with sponsors, external vendors and sites on project-related issues
  • Investigates and responds to project inquiries from field sites and sponsors
  • May assist company executives with responses to Request for Proposals (RFPs) by providing timeline, task, and resource needs

Qualifications

  • Bachelor’s degree required. Master’s degree in a health-related field preferred
  • Two to four years of project management experience with clinical trials or clinical/health research projects
  • Knowledge of clinical research operations and data management in a regulated environment
  • Familiar with GCPs and FDA regulations as they pertain to the management of clinical studies
  • Knowledge of the software development lifecycle preferred
  • Experience using Microsoft Office tools such as Word, Excel, PowerPoint, and Project
  • Experience using data management systems preferred
  • Demonstrated professional outlook and excellent communication skills

 

About KAI Research, Inc.

 

KAI Research, Inc., an Altarum company, is a full-service contract research organization (CRO) and health research company. Since 1986, we’ve helped pharmaceutical, academic, and federal clients accelerate time to market for innovative drug treatments and other interventions. We have supported several federal clients for multiple decades and coordinated hundreds of clinical trials and epidemiological studies in a wide variety of therapeutic areas.

 

Using a collaborative, “high touch” approach, we offer a wide range of clinical research services, including study management, observational studies and registries, patient recruitment and site partnerships, regulatory affairs, data management and eClinical solutions, monitoring, safety and pharmacovigilance, statistical support, and quality assurance. Our decades of experience allow us to predict needs, avoid common barriers, and move from a quick startup through each research phase.

 

KAI is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to, among other things, race, color, religion, sex, sexual orientation, gender identity, national origin, age, status as a protected veteran, or disability.

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