OptymEdge - Ophthalmic Certification Project Associate

Emmes Global

Bangalore, Karnataka
Permanent
Full-time

2 months ago

Overview:Ophthalmic Certification Project AssociateIndia - BangaloreEmmes 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 stive 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!This requirement is for our OptymEdge division. OptymEdge sets the gold standard for training and certification in ophthalmic clinical trials and brings experience and expertise from having the largest and longest-standing certification organization in the industry. Pioneering visual acuity certification from conception, we have developed proven solutions for training and certification of Visual Function Examiners and Visual Function Rooms, and partner with study teams to provide visual function certification that ensures a high level of quality and consistency for ophthalmic clinical trial data. OptymEdge has certified over 2000 sites worldwide since 1995, working on Phase I through post-marketing trials in clinical Ophthalmology, Optometry, and other therapeutic areas.Primary PurposeThe Ophthalmic Certification Project Associate (OCPA) is critical to the successful conduct of ophthalmic certifications in Biopharmaceutical-sponsored clinical trials. The OCPA supports the Manager, Ophthalmic Certification Project Management Group (OCMPG) and Ophthalmic Certification Project Managers by providing logistical support for electronic document filing and archiving, reporting requirements and other duties required by the statement of work. The OCPA will be site-facing through the life cycle of the study, and contributes to team and financial efficiency, work product quality, and client satisfaction through strong relationship management. Responsibilities:

Leads project-specific certification activities at the direction of the Manager, OCMPG and Ophthalmic Certification Project Managers
Performs certification data entry and works in the certification database at the direction of the Manager, OCMPG and Ophthalmic Certification Project Managers
Assists with providing support in tracking, compiling, and submitting project deadlines and deliverables
Assists with the collection of electronic and paper-based project files and archives
Assists with the review of study related documents, certifications and data to ensure quality and accuracy
Supports the coordinating of conference calls and meetings
Edits, formats, tracks and distributes technical and non-technical reports
Attends and participates in department team meetings
Performs other duties as assigned

Qualifications:

Bachelor’s degree preferred or equivalent experience will be considered

2 years demonstrating related experience
Demonstrated experience with MS Office Suite, particularly MS Word
Time management and decision-making skills
Attention to detail and the ability to address several assignments simultaneously
Excellent oral and written communication skills
Some knowledge of clinical trials in ophthalmology preferred

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