Project Manager (Sickle Cell Study)
The EMMES Corporation, established in 1977, is a privately-owned Contract Research Organization (CRO). Headquartered in Rockville, Maryland, Emmes employs over six hundred staff worldwide with offices located in Frederick, Maryland, 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. Emmes is seeking a Project Manager
The National Heart, Lung, and Blood Institute (NHLBI) provides global leadership in research, training, and education to prevent and treat heart, lung, blood and sleep disorders. The NHLBI is convening a Cure Sickle Cell Disease Initiative (CSCI), aimed at finding innovative ways to support discovery and development of efficacious genetic therapeutic approaches and bring them to scale in clinical populations to accelerate finding curative treatments for Sickle Cell Disease (SCD). The NHLBI is working with The EMMES Corporation to establish a Coordinating Center (CC) for the CSCI and to engage key staff of this initiative.
- Coordinates and directs activities of cross-functional team members for the completion of project deliverables. Develops and manages timelines for production and delivery of reports, deliverables, and other work products. Notifies the PI/CRM/Corporate Leader of deviations from the timelines and proposes revised timelines or corrective actions
- Serves as the Emmes project expert on assigned protocols/studies/activities and demonstrates ability to integrate, summarize and communicate project activities to internal and external teams
- Communicates and interacts with Emmes project staff regarding project requirements and deliverables. Communicates with and updates project team members on all relevant issues
- Prepares, critically reviews, and/or approves required deliverables and project materials (e.g., Manual of Operating Procedures). Verifies that deliverables meet applicable project and /or contract requirements
- Represents the project at NHLBI meetings and other client-directed activities
- Fosters a collaborative and respectful relationship with NHLBI, other external stakeholders and Emmes project team members. Earns the trust and respect of internal and external colleagues
- Leads, participates in, or contributes to staff performance evaluations
- Leads project process improvement and corporate quality assurance activities through interactions with the Internal Quality Audit Team (IQAT), project SOP and Compliance/Variance table development, participation in internal and external audits, staff training, and professional development activities
- Develops, oversees or participates in project budget and/or resource allocation management activities including short and long-term staffing plans and staffing assignments
Preparation and follow up with project activities (committee calls, web seminars, workshops, symposiums)
Attends and participate in weekly internal staff meetings for project updates and tasks assignments
Attends and participate in scheduled project sub-committee calls with NHLBI
Attends project Executive and Governance Committee calls with NHLBI
Attends scientific meetings on behalf of the project
Assists in the preparation of project conference calls and meeting minutes. Contributes in writing call and meeting minutes and follow up on action items
- Assists in the preparation of project-required reports Assists in writing, editing, and tracking project-related publications
- Ensures adherence to project and corporate standard operating procedures (SOPs), as well as Federal Regulations and ICH/GCP in maintaining data integrity and quality throughout the project
- Preferred: Bachelor’s degree and 4 years related experience or Master’s degree and 2 years related experience, and demonstrated working knowledge of scientific principles appropriate to the position
- Knowledge of clinical research including the critical elements for the development and execution of clinical trials or research studies
- Prior project leadership experience is preferred Prior knowledge of cellular & genetic therapy and sickle cell disease is a definite plus
- Strong skills in prioritization, organization, problem solving, decision-making, time management, mentoring and planning
- Good interpersonal skills and ability to deal with staff at all levels with sensitivity and tact
- Demonstrates ability to foster concepts of teamwork, research integrity, ethical conduct and personal responsibility
- Ability to self-direct and work independently and in a complex team environment Excellent oral and written communication skills with the ability to effectively communicate and coordinate with internal and external clients and colleagues
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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.