The Emmes Company, LLC (“Emmes”) is searching for Global Clinical Project Managers. Emmes provides flexibility for the office location or work remote preference dependent upon position.
Emmes is a Contract Research Organization (CRO). Headquartered in Rockville, Maryland, Emmes employs over nine 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.
Primary PurposeThe Global Clinical Project Manager (CPM) is critical to the successful conduct of Biopharmaceutical-sponsored clinical trials as a matrix leader of the core project team. The CPM is responsible for the successful delivery of a Biopharmaceutical project(s) from the development of the RFP including study budget, proposed staffing and timelines. The CPM will be client-facing and serve as the internal lead of the project through the life cycle of the study, ensuring effective project delivery in agreement with contracted project timeline and budget. The CPM directs project delivery by driving team and financial efficiency, work product quality, and is responsible for client satisfaction through strong relationship management.
- Serves as a primary lead in developing RFPs for biopharma clients, identifying appropriate staff, preparing proposal language, and developing budget and timelines in collaboration with leaders and key subject matter experts (SMEs)
- Ensures that deliverables for the assigned project/s are completed according to the contract budget, schedule, and quality standards. Projects will be effectively managed in all areas of performance
- Develops successful working relationships with clients, executive management, and project staff and collaborate to manage project issues, proactively identify and mitigate risks and drive milestone achievement
- Serves as the primary point of contact for biopharma clients and demonstrate proficiency in knowledge and understanding of client needs
- Tracks project deliverables against contract using Emmes’ tools. Proactively prepare/present study metrics to maintain transparency for internal/external stakeholders. Monitor trends and drive changes to the plan as needed; identify risks to delivery and agree mitigation plans with the project team to be presented to the client
- Ensures adherence to quality control expectations and milestone timelines for delivery of contractually required reports and deliverables
- Oversees all project resources (i.e., budget, personnel, and subcontracts)
- Identifies and manage changes to scope and requests for out-of-scope activities. Collaborate with Business Development, Contracts Department, and executive management to ensure timely execution of contract amendments/change orders. Prospectively manage client expectations
- Presents in bid defense meetings in collaboration with Business Development
- Develops study management plans in collaboration with Clinical Study Manager (CSM)/Clinical Team Lead (CTL), Clinical Research Manager (CRA) and other core team members
- Identifies and documents lessons learned from study successes and challenges to promote development of best practices
- Models and propagates Emmes’ commitment to a culture of quality in all aspects of our deliverables, utilizing a solution-based, science-driven, value-added approach in collaborating with clients
- Other duties as assigned
- Bachelor’s degree in a scientific discipline with a minimum 8 years demonstrating scientific principles appropriate in managing a clinical research portfolio inclusive of 3 or more years in a pharmaceutical and/or CRO setting, serving in a global Clinical Trial Team Lead or CPM role or equivalent position.
- Demonstrable track-record of success delivering complex/ high priority clinical trials within agreed time, quality and cost working across multiple therapeutic areas, phases 1-3, in a global capacity
- Demonstrated experience in developing and fostering strong client and internal relationships
- Thorough understanding of ICH GCP and all applicable global regulatory regulations and guidelines
- Skilled in MS Office Suite of products and working knowledge of Clinical Trial Management Systems, electronic Trial Master File, and electronic Data Capture systems and solutions
- Demonstrated experience in managing diverse staff and leading successful teams with direct and indirect supervision responsibilities
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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.