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Clinical Trial Associate

Remote:

Full Remote

Contract:

Full time

Experience:

Mid-level (2-5 years)

Work from:

United States

Offer summary

Qualifications:

Bachelor’s degree in health or science, Minimum 3 years in medical device/pharmaceutical industry, 1 year clinical research experience, Proficiency in MS Office suite and relevant software.

Key responsabilities:

Execute and manage clinical trial activities
Coordinate study documents and relate administrative tasks
Assist with vendor selection and management
Document decisions, actions, and risks
Ensure training documentation for team members

Ocular Therapeutix, Inc. Pharmaceuticals SME

51 - 200 Employees

See more Ocular Therapeutix, Inc. offers

Job description

Ocular Therapeutix, Inc. (NASDAQ:OCUL) is a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary bioresorbable hydrogel-based formulation technology, ELUTYX™. Ocular Therapeutix has built a robust product pipeline of drug delivery solutions developed to reduce the complexity and burden of the current standard of care and position itself to become a leader in the ophthalmic space.

Outside of the ophthalmic realm and behind the doors of our headquarters in Bedford, MA, we strive to build a strong culture where employees can flourish and achieve their career goals. We encourage out of the box thinking, cross-functional collaboration, and creativity.

Position Summary:

In this role you will execute and coordinate activities associated with the set-up, management, and close-out of clinical trials. Collaborate with other functional areas to facilitate administrative tasks including invoices and contracts for processing. Assist in oversight of outsourced activities.

Responsibilities:

The scope of study responsibilities includes supporting the effective coordination of the activities of the clinical trial, management of project information and communications to all stakeholders through the lifecycle of drug development.
Assist the Clinical Project Manager in management, execution, and oversight of assigned studies/tasks incl.
- Coordinate the development and review of study documents (i.e., posting study specific training documents in MC, IB, Protocol, ICF, plans, manuals, site recruitment materials, CSRs, etc.)
Assists with vendor selection and management activities, incl. management of applicable documentation and systems.
Functional contact for CROs and vendors. Documents meetings as assigned.
Assists with the development and maintenance of study timeline and processing of 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

Qualification Requirements:

Bachelor’s degree in health profession or science field
A minimum of 3 years of experience in the medical device or pharmaceutical industry, including 1 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
Office or remote based. Some travel may be required for educational seminars, on-site study oversight and site engagement visits. Ability to travel approximately 5%.

Ocular Therapeutix is an Equal Opportunity Employer and complies with all applicable federal, state, and local laws regarding nondiscrimination. Ocular Therapeutix provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, or status as a veteran. For information on how Ocular Therapeutix collects, stores, and utilizes candidate information please see our privacy policy found at https://www.ocutx.com/privacy-policy/.