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Emmes · 5 days ago

Global Project Manager - Ophthalmology

United States

Full-time

Remote

Senior Level, Lead/Staff

8+ years exp

Emmes Group is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients. The Global Project Manager (GPM) is responsible for the successful delivery of Biopharmaceutical projects, ensuring effective project delivery in agreement with contracted project timelines and budget.

BiopharmaBiotechnologyClinical TrialsHealth CareMedical

Responsibilities

May serve as a primary lead for project bids and multi trial initiatives

Ensures that deliverables for assigned project(s) are completed according to the contract budget, schedule, and quality standards. Effectively manages projects in all areas of performance

Develops effective working relationships with clients, executive management, and project staff. Collaborates with stakeholders to manage project issues, proactively identify and mitigate risks and drive milestone achievement

Serves as the primary point of contact for biopharma clients. Demonstrates proficiency in knowledge and understanding of client needs

Tracks project deliverables against contract using Emmes’ tools. Proactively prepares/presents study metrics to maintain transparency for internal/external stakeholders. Monitors trends and drives changes to the plan as needed; identifies risks to delivery and collaborates with the project team to develop mitigation plans to be presented to the client

Ensures adherence to quality control expectations and milestone timelines for delivery of contractually required reports and deliverables

Manages project resources (i.e., budget, personnel, and subcontracts)

Identifies and manages change to scope and requests for out-of-scope activities. Collaborates with Business Development, the Contracts Team, and executive management to ensure timely execution of contract amendments/change orders. Prospectively manages client expectations

May present in bid defense meetings in collaboration with Business Development

Develops study management plans in collaboration with core project 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

Performs other duties as assigned

Qualification

Clinical trial managementClient relationship managementProject managementICH GCP knowledgeMS Office SuiteClinical Trial Management SystemsCommunication skillsTeam leadership

Required

Bachelor's degree in a scientific discipline

Minimum 8 years demonstrating scientific principles appropriate in managing a clinical research portfolio including multi-phase research experience in a broad range of indications and client types

At least 3 years working in a pharmaceutical and/or CRO setting, serving in a global Trial Team Lead or Global Project Management 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 1-4, in a global capacity

Demonstrated experience in developing and fostering client and internal relationships

Thorough understanding of ICH GCP and 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

Successful record in managing diverse staff and leading strong teams

Strong verbal and written communication skills