Manager, Clinical Data Management
Job Posting for Manager, Clinical Data Management at Ocular Therapeutix
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. Our robust product pipeline positions Ocular Therapeutix to become a leader in the ophthalmic space due to our ability to create drug delivery solutions that reduce the complexity and burden of the current standard of care by developing sustained release alternatives.
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 Clinical Data Manager is responsible to effectively execute the data management activities and assist in oversight of data management vendors.
Principal Duties and Responsibilities include the following:
- Perform Lead DM (Data Management) responsibilities for assigned studies.
- Assist with the design of the clinical database based on protocol and study needs, including queries and dynamics
- Perform User Acceptance Testing of the clinical database
- Author study specific DM documentation (DMPs, CCGs, DTAs, EDC specifications)
- May assist in data cleaning activities for assigned studies
- Monitor study progress to ensure successful achievement of study milestones
- Provide oversight of data management vendors for assigned studies.
- Ensure that all data management operations are conducted to Ocular Therapeutix SOPs or CRO (Contract Research Organization) SOPs if applicable.
- Identify and communicate potential risks/challenges to AD of Data Management and study CPM based on protocol, timelines, forecasts, and study metrics. Assist the study team in the implementation of solutions.
- Ensure data management study documents are filed in the TMF (Trial Master File) in a timely manner.
- Oversee tasks delegated to Associate Data Managers for the assigned studies.
- Perform other duties as required
Qualification Requirements:
- Educated to degree level (preferably Life Science), Nursing qualification, or relevant industry experience
- Five years of clinical data management experience.
- Minimum 3 years of Lead DM experience at a CRO is required
- Knowledge of SOPs, GCP (Good Clinical Practice) standards, and clinical data management systems
- Must have experience with EDC systems; Zelta/IBM Clinical and Medrio experience preferred
- Computer literacy, proficiency in MS Office suite, TEAMS, SharePoint etc., with expert skill in Excel required
- Excellent written and oral communication skills
- Excellent organizational skills and attention to detail
- Ability to prioritize and multitask is required
Working Conditions:
This position will be fully remote. The ability to travel less than 5% would be desirable, but not required.
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/.
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Job openings at Ocular Therapeutix
Richmond, VA
Full Time
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