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:
The Manager, Clinical Data Management (CDM), is responsible for effective execution of CDM activities performed in-house or outsourced. Provides oversight of CDM vendors and ensures data management activities meets Ocular quality standards.
Principal Duties and Responsibilities include the following:
- Performs Lead CDM role for assigned studies
- Designs and/or assists with design of the clinical database based on protocol and study needs, including queries and dynamics
- Performs User Acceptance Testing (UAT) of the clinical database
- Authors, reviews, and approves study specific CDM documentation (DMPs, CCGs, DTAs, EDC specifications)
- Performs data cleaning activities for assigned studies; provide oversight of data cleaning activities for outsources studies
- Monitors study progress to ensure successful achievement of study milestones
- Provides oversight of CDM vendors for assigned studies
- Ensures that all CDM operations are conducted according to applicable SOPs
- Identifies and communicates potential risks/challenges to head of CDM and study CPM based on protocol, timelines, forecasts, and study metrics.
- Collaborates with the study team to identify, develop, and implement risk-based solutions
- Ensures CDM study documents are filed in the TMF (Trial Master File) in a timely manner
- May oversee tasks delegated to other CDM staff for assigned studies
- Performs other duties as required
Qualification Requirements:
- Bachelor’s degree in health profession, science, or related field
- Six to eight (6-8) years of CDM experience. Minimum 3 years of Lead CDM experience
- Knowledge of SOPs, GCP (Good Clinical Practice) standards, and CDM systems
- Experience with multiple EDC systems
- Experience with other CDM systems such as analytics desired
- Advanced MS Excel skills (formulas, pivot tables); basic SAS or other programming is a bonus
- Computer literacy, proficiency in MS Office suite, TEAMS, SharePoint etc
- Excellent written and oral communication skills
- Excellent organizational skills and attention to detail
- Ability to prioritize and multitask
This position will be fully remote. The ability to travel less than 5% would be desirable, but not required.
Salary Range
$150,000—$165,000 USD
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.
