Senior Study Director-CRO
The Emmes Corporation is searching for Senior Study Directors with CRO experience 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 Study Directors will be responsible for managing one or more commercially-funded multicenter clinical trials. The Senior Study Director 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 ophthalmology, transplantation or cellular therapy trials is preferred.Responsibilities
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
- 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
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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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