Contract - Clinical Project Manager en Ocular Therapeutix
Ocular Therapeutix · Bedford, Estados Unidos De 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 Contract Clinical Project Manager (CPM) executes and/or oversees the coordination of activities associated with the set-up, management and closure of clinical studies and is responsible for the successful completion of studies on schedule, within budget and with high quality standards.
Principal Duties and Responsibilities include the following:
(Other duties may be assigned)
- The scope of study responsibilities includes effectively coordinating the activities of the clinical trial team and manage project information and communications to all stakeholders through the lifecycle of drug development
- Manage and/or oversee the execution of assigned studies
- Collaborates with internal and external stakeholders to ensure alignment of responsibilities.
- Manage the development and review of study documents (i.e., IB (Investigator Brochure), Protocol, ICF (Informed Consent Form), plans, manuals, site recruitment materials, CSRs (Clinical Study Report), etc.)
- Overall responsibility for the TMF (Trial Master File)
- Executes vendor identification, selection, and management activities
- Contribute to clinical Program Team meetings with internal stakeholders to establish effective information sharing and collaboration
- Main point of contact for CROs (Contract Research Organizations) and vendors and lead CRO/vendor meetings for assigned studies
- Oversee and manage study timelines / budgets / contracts and report/escalate issues as needed
- Ensure study training is planned, provided, and documented for all study team members
- Ensures study specific decisions, actions, issues and risks are identified and documented throughout the study's lifecycle and reviewed regularly. Escalate as appropriate
- Oversee use of systems to track and monitor clinical program objectives/goals
- Manage inspection readiness activities
- Perform other duties as required
- May conduct quality oversight engagement visits. Responsible to foster site relationships
Qualification Requirements:
- Bachelor’s degree in health profession or science field
- A minimum of 8 years of experience in the medical device or pharmaceutical industry, including 6 years of relevant clinical research experience
- Some monitoring experience is preferred
- Previous experience leading a clinical study 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 (Good Clinical Practice) 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.
