Senior Project Manager - Real World Evidence

Senior Project Manager - Real World Evidence

Germany Remote - Munich office-based (preferred)

The Emmes Company, LLC ("Emmes") is a global, full-service Clinical Research Organization dedicated to excellence in supporting the advancement of public health and biopharmaceutical innovation. We believe in the power of truth, so much so that we named our company Emmes, which means truth. Through decades of experience we have learned that collaborative relationships thrive and human health benefits when truth is our compass.

Our "Character Achieves Results" culture is driven by five key values that guide our actions in the way we conduct research and distinguish us as an organization: Integrity, Agility, Passion for Excellence, Collaborative Partnerships and Intellectual Curiosity. We are a trusted partner to clients who share our passion for improving public health in a world of ever-changing scientific research.

If you share our motivations and passion in research, come join us! You will be joining a collaborative culture that empowers every Emmes employee — from entry level through top executive — to contribute to our clients' success by sharing ideas openly and honestly.

Primary Purpose

The Senior Project Manager, Real World Evidence (Sr PM, RWE) is critical to the successful conduct of Biopharmaceutical-sponsored clinical trials as a matrix leader of the core project team. The Sr PM, RWE is responsible for the successful delivery of Real World Evidence project(s). The Sr PM RWE 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 Sr PM directs project delivery by driving team and financial efficiency, work product quality, and is responsible for client satisfaction through strong relationship management.

Responsibilities

• 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 Leads from Data management, Biostatistics and Pharmacovigilance
• 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

Experience

• Bachelor's degree in a scientific discipline
• Minimum 3 years demonstrating scientific principles appropriate in managing a clinical research portfolio inclusive of 2 or more years in a CRO setting, serving in a Real World Evidence Project Manager role
• Demonstrable track-record of success delivering complex / high priority clinical trials within agreed time, quality and cost working across multiple therapeutic areas, Phase IV and Real World Evidence Studies, in a multi country capacity
• Demonstrated experience in developing and fostering strong client and internal relationships
• Thorough understanding of ICH GCP, GEP and all applicable RWE 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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