Associate, Clinical Project Management

October 20

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Ocular Therapeutix, Inc.

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ocular drug delivery • surgical sealants • sustained delivery • ophthalmic therapies • ophthalmology

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Description

• The Associate, Clinical Project Management assists with the execution and coordination of activities associated with the set-up, management, and closure of clinical studies with high quality standards. • The scope of study responsibilities includes supporting the effective coordination of the activities of the clinical trial team and manage project information and communications to all stakeholders through the lifecycle of drug development. • Assist in management, execution, and oversight of assigned studies. • Maintains task ownership matrix to document internal and external stakeholders’ responsibilities. • Coordinate the development and review of study documents (i.e., IB, Protocol, ICF, plans, manuals, site recruitment materials, CSRs, etc.). • Conduct TMF review and QC tasks as assigned. • Assists with vendor identification, selection and management activities, incl. management of applicable documentation and systems. • May represent clinical operations at project team and other cross-functional meetings. • Functional contact for CROs and vendors. Documents meetings as assigned. • Assists with the development and maintenance of study timeline and budget/invoice/contracts and other trackers. • Ensure study training is documented for all study team members. • Document study specific decisions, actions, issues, and risks throughout the lifecycle of the study. • Maintain data in assigned systems. • Assist on inspection readiness activities. • Perform other duties as required. • May conduct quality oversight and site engagement visits.

Requirements

• Bachelor’s degree in health profession or science field • A minimum of 5 years of experience in the medical device or pharmaceutical industry, including 3 years of relevant clinical research experience • Some monitoring experience is preferred • Excellent written and oral communication skills • Computer literacy, proficiency in MS Office suite, TEAMS, SharePoint etc. • Excellent organizational skills and attention to detail • Ability to work virtually • Ability to apply knowledge of GCP and applicable regulations and guidance’s appropriately