Clinical Study Manager

Location
Rockville, Maryland
Salary
Competitive
Posted
Sep 19, 2020
Closes
Oct 16, 2020
Ref
2553
Function
Management
Industry
Science
Hours
Full Time
The Emmes Company, LLC ("Emmes") is searching for three Clinical Study Managers to join its growing Clinical Study Management department.

The Emmes Company, LLC is a 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.

Purpose

The Clinical Study Manager (CSM) is responsible for assisting with operational support activities for a protocol or group of protocols, including guiding study timelines for clinical research studies at external trial sites. The CSM will identify problems and propose solutions, while making decisions in consultation with others as relevant.

Responsibilities
  • Assist investigators with concept and protocol development, approval, and revision processes as required by the protocol team, pharmaceutical collaborators, correlative science collaborators, and other resources
  • Coordinate the development of and revision of protocol-specific documentation (e.g. Operations Manuals, Standard Operating Procedures, work instructions, and other required documentation)
  • Critically review and comment on study protocols, informed consents and other study documents
  • Triage incoming site inquiries to the appropriate team member and ensure follow up as needed Moderate monthly working group calls, protocol development calls and other relevant conference calls for assigned disease area
  • Contribute to the quality and accuracy of clinical study reports
  • Identify site staff training needs, support the development of training materials, and deliver training
  • Identify and track site and protocol related deliverables for the lifecycle of a study
  • Meet deadlines for deliverables to sponsor
  • Create and manage timelines (initiation, implementation and closeout) and other tasks as needed
  • Collaborate with internal and external team members to improve study conduct, monitoring and assure compliance with study procedures
  • Write study specific memoranda, major email communications, and other study specific communications
  • Assist with clinical study drug procurement and importation to clinical sites, as needed
  • Document workflow for assigned tasks
  • Support protocol safety reviews and cohort management for dose escalation/de-escalation trials, including preparation of summary memoranda and maintenance of screening lists

Experience
  • Bachelor's degree in a scientific discipline
  • Minimum 2 years of clinical research experience
  • Skills in prioritization, problem solving, organization, decision-making, time management, and planning
  • Prior knowledge of GCP, HSP, and regulatory guidelines and regulations helpful
  • Detail-oriented, excellent presentation, oral, and written communication skills required
  • Ability to function effectively on a team, providing and receiving constructive feedback
  • Communicates and coordinates effectively with internal project staff members, site staff, sponsors, clients and other external colleagues


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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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