Global Clinical Project Manager
2 months ago
**Global Clinical Project Manager**
**Canada Remote Worker**
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 Associate Global Clinical Project Manager (AGCPM) is critical to the successful conduct of Biopharmaceutical-sponsored clinical trials as a matrix leader of the core project team. The AGCPM 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 AGCPM 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**
- 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.
- May serve as the primary point of contact for assigned 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 manages 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.
- Assists in presenting in bid defense meetings in collaboration with Business Development for assigned clients.
- 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.
**Experience**
- Bachelor’s degree in a scientific discipline with a m inimum 4 years demonstrating scientific principles appropriate in managing a clinical research portfolio inclusive of 1 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
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