Clinical Research Manager

Location
Rockville, Maryland
Salary
Competitive
Posted
Jun 08, 2019
Closes
Jul 08, 2019
Ref
2124
Industry
Science
Hours
Full Time
The Emmes Company LLC, established in 1977, is a private Contract Research Organization (CRO). Headquartered in Rockville, Maryland, Emmes employs over six hundred staff worldwide with offices located in Frederick, Maryland, Tysons Corner, Virginia, 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 are dedicated to providing statistical and epidemiological expertise, computer systems deployment, data management, study monitoring, regulatory guidance, and overall operational support to clients engaged in biomedical research. Emmes offers support for the entire process of clinical trials from study design and protocol development through data analysis and manuscript generation.

Primary Purpose

The Clinical Research Manager (CRM) is responsible for managing the overall direction, planning, execution and oversight of projects. Project management includes strategic planning, budget and resource management, data collection and clinical operational activities. The CRM establishes methods to implement and support clinical research, ensures timely submission of contract deliverables and processing of clinical agreements, and participates in the selection of subcontractors when required by scope of work. In collaboration with others, the CRM manages clinical trials by reviewing protocols for consistency, identifies forms for data collection and analysis and assures validation of data collection mechanisms. The Clinical Research Manager also oversees protocol-monitoring components of projects including oversight of external CRAs and/or internal protocol monitors. Clinical Research Managers may serve as Principal Investigators

Responsibilities
  • Independently selects, trains, develops and evaluates Emmes study personnel to ensure efficient project operation
  • Coordinates activities of cross-functional teams and oversees operational, data management, regulatory, monitoring, and protocol development processes associated with clinical trials
  • Serves as primary point of contact for the client's Project Officer/Sponsor, External Investigators or Laboratory site staff and internal Emmes staff members
  • Represents project at Sponsor, Investigator, Training or Safety Review meetings, and/or Data and Safety Monitoring Board meetings
  • Fosters a collaborative and respectful relationship with contract sponsors, other external stakeholders and Emmes project team members
  • Develops and adheres to a timetable for production and delivery of contractually required reports and products
  • Manages project resources (i.e., budget, personnel, and subcontracts) to ensure that project tasks are performed efficiently and on a timely basis
  • Prepares Emmes IRB materials for initial and continuing reviews and ensures project compliance with IRB requirements
  • Attends and participates in project and functional group meetings
  • Designs and implements efficient work processes, schedules and checklists to ensure routine clinical trial and other project activities are performed in accordance with corporate, project-specific Standard Operating Procedures (SOPs) and applicable regulatory agencies
  • Authors or contributes to study reports including Clinical Study Reports, manuscripts and/or scientific presentations
  • Provides major contributions to business development and proposal preparation
  • Demonstrates understanding of project and corporate SOPs by producing work in compliance with the SOPs
  • Maintains documentation required by corporate and project SOPs
  • Participates in project process improvement and corporate quality assurance activities through Internal Quality Audit Team (IQAT), project SOP and Compliance/Variance table development, participation of internal and external audits, and professional development activities
  • Promotes continued professional growth of staff by supporting attendance at internal or outside conferences and other educational opportunities
  • Makes or contributes to staff hiring and retention decisions and makes staff level assignments for defined job titles
  • Oversees the conduct of a clinical trial at the clinical centers, laboratories and the coordinating center, and communicates issues and recommends solutions to the appropriate oversight committees
  • Prepares, critically reviews and approves required study and project materials including Manual of Operating Procedures (MOPs), Project Management Plans, and project SOPs
  • Oversees subcontracted facilities, consultants, or other resources utilized by the project team
  • May performs data management, regulatory, protocol monitoring, protocol development and/or quality assurance duties, as appropriate

Experience
  • Master's degree in a scientific discipline and 8 years of demonstrated working knowledge of scientific principles appropriate to the position, including at least 2 or more years serving as a clinical research specialist or in an equivalent position or a bachelor's degree in a scientific discipline and 10 or more years of experience plus 2 or more years serving as a clinical research specialist considered in lieu of Master's degree
  • Expertise in one or more technical specialized areas of clinical research including clinical project management, data management, regulatory affairs, CRA services/protocol monitoring, protocol development, and/or quality assurance
  • Proven experienced, effective leadership of full-service clinical research teams as demonstrated through previous management roles
  • Strong skills in prioritization, problem solving, organization, decision-making, time management, negotiation, mentoring and planning including excellent oral and written communication skills
  • Self-motivated, proactive and detail-oriented
  • Proven ability to work independently, as well as in a complex team environment
  • Ability to travel as required by project needs
  • Hematology/oncology and/or hematologic transplant experience preferred


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The Emmes Company LLC 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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