Ocular Therapeutix, Inc.
Contract - Clinical Project Manager
Ocular Therapeutix, Inc., Jackson, Mississippi, United States
Overview
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 hydrogel-based ELUTYX technology. The company has built a robust product pipeline of drug delivery solutions to reduce the complexity and burden of the current standard of care and aims to be a leader in the ophthalmic space. The company values 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. Responsibilities
Coordinate 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. Collaborate with internal and external stakeholders to ensure alignment of responsibilities. Develop and review study documents (e.g., Investigator Brochure, Protocol, Informed Consent Form, plans, manuals, site recruitment materials, Clinical Study Reports). Maintain overall responsibility for the Trial Master File (TMF). Identify, select, and manage vendors; conduct vendor management activities. Contribute to clinical Program Team meetings to establish effective information sharing and collaboration. Serve as main point of contact for CROs and vendors and lead CRO/vendor meetings for assigned studies. Oversee study timelines, budgets, contracts and escalate issues as needed. Ensure study training is planned, provided, and documented for all study team members. Identify and document study decisions, actions, issues and risks; monitor and 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 and foster site relationships. Qualifications
Bachelor’s degree in a health profession or science field. 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 is preferred. Excellent written and oral communication skills. Excellent organizational skills and attention to detail. Ability to work virtually. Ability to apply knowledge of GCP and applicable regulations and guidance 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.
#J-18808-Ljbffr
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 hydrogel-based ELUTYX technology. The company has built a robust product pipeline of drug delivery solutions to reduce the complexity and burden of the current standard of care and aims to be a leader in the ophthalmic space. The company values 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. Responsibilities
Coordinate 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. Collaborate with internal and external stakeholders to ensure alignment of responsibilities. Develop and review study documents (e.g., Investigator Brochure, Protocol, Informed Consent Form, plans, manuals, site recruitment materials, Clinical Study Reports). Maintain overall responsibility for the Trial Master File (TMF). Identify, select, and manage vendors; conduct vendor management activities. Contribute to clinical Program Team meetings to establish effective information sharing and collaboration. Serve as main point of contact for CROs and vendors and lead CRO/vendor meetings for assigned studies. Oversee study timelines, budgets, contracts and escalate issues as needed. Ensure study training is planned, provided, and documented for all study team members. Identify and document study decisions, actions, issues and risks; monitor and 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 and foster site relationships. Qualifications
Bachelor’s degree in a health profession or science field. 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 is preferred. Excellent written and oral communication skills. Excellent organizational skills and attention to detail. Ability to work virtually. Ability to apply knowledge of GCP and applicable regulations and guidance 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.
#J-18808-Ljbffr