Overview:
Emmes Group: Building a better future for us all.
Emmes Group is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients. Emmes Group was founded as Emmes more than 47 years ago, becoming one of the primary clinical research providers to the US government before expanding into public-private partnerships and commercial biopharma. Emmes has built industry leading capabilities in cell and gene therapy, vaccines and infectious diseases, ophthalmology, rare diseases, and neuroscience.
We believe the work we do will have a direct impact on patients lives and act accordingly. We strive to build a collaborative culture at the intersection of being a performance and people driven company. We're looking for talented professionals eager to help advance clinical research as we work to embed innovation into the fabric of our company. If you share our motivations and passion in research, come join us!
Primary Purpose
The Global Clinical Project Manager (GCPM) is critical to the successful conduct of Biopharmaceutical-sponsored clinical trials as a matrix leader of the core project team. The GCPM 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 GCPM 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 GCPM directs project delivery by driving team and financial efficiency, work product quality, and is responsible for client satisfaction through strong relationship management.
Responsibilities:
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.Qualifications:
Bachelor's degree in a scientific discipline
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 GCPM 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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