Manager, Clinical Data Management
Ocular TherapeutixBedford, MA
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Overview
Schedule
Full-time
Career level
Director
Remote
Remote
Job Description
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.
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FAQs About Manager, Clinical Data Management Jobs at Ocular Therapeutix
What is the work location for this position at Ocular Therapeutix?
This job at Ocular Therapeutix is located in Bedford, MA, according to the details provided by the employer. Some roles may also include multiple work locations depending on the requirement.
What pay range can candidates expect for this role at Ocular Therapeutix?
Employer has not shared pay details for this role.
What employment applies to this position at Ocular Therapeutix?
Ocular Therapeutix lists this role as a Full-time position.
What experience level is required for this role at Ocular Therapeutix?
Ocular Therapeutix is looking for a candidate with "Director" experience level.
Does Ocular Therapeutix allow remote work for this role?
Yes, this position at Ocular Therapeutix supports remote work, giving candidates the flexibility to work outside the primary office location.
What is the process to apply for this position at Ocular Therapeutix?
You can apply for this role at Ocular Therapeutix either through Sonara's automated application system, which helps you submit applications 10X faster with minimal effort, or by applying manually using the direct link on the job page.