Associate Clinical Project Manager na Ocular Therapeutix
Ocular Therapeutix · Bedford, Estados Unidos Da América · Remote
- Professional
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:
The Associate Clinical Project Manager assists with the execution and coordination of activities associated with the set-up, management, and closure of clinical studies with high quality standards.
Principal Duties and Responsibilities include the following:
(Other duties may be assigned)
- 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, including 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
Qualification 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
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/. For the Privacy Notice for California Job Applicants, please see CCPA Applicant Notice.
