Project Leader - Ophthalmology- Remote (Full-time or Part-time)

Project Leader (Ophthalmology)

India 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

Project Leaders successfully execute clinical research projects while maintaining a positive, effective, and responsive relationship with clients. As an expert in the clinical research field, the Project Leader uses professional concepts in developing resolution to critical issues. Holding primary accountability for technical, scientific, fiscal and management oversight for one or more projects within the Subtance Use research unit, the Project Leader proactively communicates with internal and external stakeholders to provide timely resolution for strategic issues that impact upon project outcomes. As a leader in the organization, this position partners routinely with the business development team to generate and grow new business.

The MacTel Project is designed to identify the causes and possible treatments for Macular Telangiectasis Type 2 (MacTel Type 2), an uncommon and poorly understood retinal vascular disease. The Project is funded by the Lowy Medical Research Institute, a non-profit foundation.

Emmes serves as the CRO for the Natural History Observational Registry, the Phase II Bilateral Safety Study, and the Phase III International, Multicenter Clinical Trials to assess the safety, tolerability, and efficacy of Ciliary Neurotrophic Factor (CTNF), a class of molecules that has been demonstrated to slow the loss of photoreceptor cells during retinal degeneration. The clinical trials involve implanting a capsule into the vitreous of the eye that secretes the CNTF, thus making the molecules available to the photoreceptor cells of the retina. This capsule is called the NT-501 device.

The Natural History Observational Registry enrollment is ongoing, the Phase I and Phase II Extension Study is closed, the Phase II Bilateral Safety Study is in the start-up/enrollment period, and the Phase III Clinical Trials are in the follow-up period.

Emmes provides statistical services, regulatory document support, data management, medical monitoring, on-site monitoring, data/text/tables for IND/DSUR/DSMC/Safety Reports, and project management for approximately 60 Natural History sites in the US, Australia, and Europe and 45 Clinical Trial sites in the US, Australia, and Europe.

Responsibilities
  • Accountable for technical, scientific, fiscal, and overseeing of research projects working with staff at Emmes responsible for research support activities, including but not limited to Clinical Operations, Statistical and Scientific Innovation, Regulatory Affairs, and Pharmacovigilance
  • Proactively assesses client expectations and addresses client's needs for ongoing studies/support and engages with clients for new opportunities in support of future studies
  • Reviews, provides input on, and approves project and study documents and processes, as needed
  • Represents the project or company at client meetings and scientific conferences
  • Utilizes broad understanding of therapeutic, clinical trial design, and/or process expertise to influence and executes project decisions considering client needs, budget considerations and the current state of the research field
  • Defines solutions with input from team members that will be implemented to meet client's needs that address contractual aspects of projects (e.g., project contracts, scope of work, budgets, subcontracts, vendor agreements) to ensure delivery of high-quality contract deliverables
  • Defines solutions with input from team members that will be implemented to mitigate risk and communicate risks and contingencies with clients
  • Approves initial budgets and statement of work documents and subsequent modifications before distribution to clients.
  • Liaises with corporate services and leaders from other Emmes verticals and departments to ensure staff resources are adequate within the project team to successfully meet the client's requirements
  • Participates in project review meetings with TRU Directors and/or TRU Oversight, and Commercial and Service Project Oversight, if applicable
  • Uses established key performance metrics to assure successful delivery of the project that meet client requirements
  • Supervises, mentors, and supports lower level project leaders (if applicable) to ensure they are properly trained for their current positions and have growth and development opportunities
  • Mentors project staff from other verticals pursuing a Project Leader role within the Therapeutic and Research Units
  • Participates in relevant corporate meetings and provides information learned and best practices to project team as applicable
  • Implements relevant corporate initiatives directed towards Project Leaders and therapeutic research areas, taking into account project budget considerations
  • Provides support to the Chief Business Officer as a subject matter expert in a therapeutic or research area and discusses business opportunities with clients and study collaborators, as appropriate
  • Contributes to the development of operational strategy, budget, and proposal content for new business opportunities

Experience
  • Demonstrated working knowledge of the principles of clinical trial management and operations with at least 3 years of management experience in a research environment
  • Prior CRO/pharmaceutical management of late-stage clinical trials
  • Demonstrable track record of success delivering complex/high-priority clinical trials within the agreed time, quality, and cost
  • Demonstrated strong problem solving and analytical skills, combined with sound business judgment
  • Ability to work proactively and effectively, with creative problem-solving and collaboration skills
  • Highly motivated with ability to work independently and as part of a multi-disciplinary team
  • Strong cross-functional project management and time management skills
  • Excellent verbal and written communication skills
  • Experience with vaccine and infectious disease clinical trials is preferred

Education/Requirements
  • Bachelor's degree, preferably in a scientific discipline, with at least 8 years of experience within pharma and/or CRO; Master's degree with at least 6 years of experience within pharma and/or CRO; PhD with at least 3 year of experience within pharma and/or CRO
  • Demonstrated working knowledge of the principles of clinical research management with at least 3 years of management experience in a research environment
  • Demonstrated strong problem solving and analytical skills, combined with sound business judgment
  • Ability to work proactively and effectively, with creative problem-solving and collaboration skills
  • Highly motivated with ability to work independently and as part of a multi-disciplinary team
  • Strong project management and time management skills
  • Excellent verbal and written communication skills


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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.

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