The Emmes Corporation is searching for a Senior Clinical Trial Manager/Commercial Project Leader located in our Frederick or Rockville, Maryland office. Emmes has offices located at the below locations and throughout the greater Washington, DC area with flexibility for office location preference, dependent upon position.
The Emmes Corporation, established in 1977, is a women-owned 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.
The Senior Clinical Trial Manager/Commercial Project Leader will be responsible for managing one or more commercially-funded multicenter clinical trials. The Manager must possess strong leadership, skill in managing personnel and projects, a strategic mindset, excellent communication and presentation skills, and a clear focus on delivery and client satisfaction to succeed in this role. Prior experience and a track record of success in leading and executing commercially-funded research studies is required. Experience with transplantation or cellular therapy trials is preferred.
Ensure that overall project deliverables, budgets, schedules, and performance standards are realistically set and attained, and that the project effectively fulfills all requirements.
Track project deliverables using appropriate tools
Develop and adhere to a timetable for production and delivery of contractually required reports and products
Manage project scope and resources (i.e., budget, personnel, and subcontracts) to ensure that project tasks are performed efficiently and on a timely basis
Proactively utilize both quality control and risk management activities to ensure project deliverables are met according to regulatory, client and Emmes requirements
Track and manage requests for out-of-scope activities; manage client expectations
Monitor and report on study status and progress towards deliverables, and escalate issues if needed, to the sponsor and/or Emmes executive management as appropriate
Overall efficient day-to-day management of the study including proactively managing study level operational aspects of the internal study team including management of study timeline, budget, resources and vendors
Serve as the primary point of contact for Clinical Operations aspects of designated projects and responsible for developing successful working relationships with clients and stakeholders
Responsible for risk mitigation strategies, associated action plan and issue resolution
Responsible for managing the project team, including ensuring all necessary project training is provided to assigned staff
Collaborate with Business Development, Contracts Department, and management staff to negotiate and ensure timely execution of change orders
Recognize the importance of, and create a culture of high quality deliverables and process improvement with a focus on streamlining our processes, adding value to our business and meeting client needs
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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.
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
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
Prior CRO/pharmaceutical management of clinical trials, preferably transplant, cellular therapy, ophthalmology or hematology/oncology trials
Highly experienced project manager with successful track record of delivering complex/ high priority clinical trials within agreed time, quality and cost
Knowledge of project management processes and tools. Qualification in Project Management (PMI certification) or equivalent is desirable
Experienced in developing, implementing and managing budgets
Excellent verbal and written communication skills, planning, decision-making, negotiation, conflict management and time management skills
Demonstrated experience of establishing strong client relationships and relationships with management staff
Experience in supervising staff and leading teams
Ability to build and maintain positive relationships with management, peers, and subordinates
Thorough knowledge of ICH GCP and relevant regulations for the conduct of clinical trials
Fluent in written and spoken English
Skilled in MS Office (Word, Excel, and PowerPoint) and MS Project
Internal Number: 1961
About The Emmes Corporation
The EMMES Corporation, organized in 1977, is a privately owned Contract Research Organization (CRO) located in Rockville, Maryland. EMMES is dedicated to providing statistical and epidemiological expertise, computer systems development, data management, study monitoring, regulatory guidance, and overall operational support to clients engaged in clinical and biomedical research.