Sr. Associate, Clinical Data Manager - Contractor bei Ocular Therapeutix
Ocular Therapeutix · Bedford, Vereinigte Staaten Von Amerika · Onsite
- Professional
- Optionales Büro in Bedford
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 Senior Associate, Clinical Data Management (CDM) works with cross-functional teams and vendors to deliver high-quality data for analysis, including leading CDM activities for in-house studies and the oversight of CDM vendors for outsourced studies.
Principal Duties and Responsibilities include the following:
- Designs in-house clinical databases, and/or assists the CDM vendor team, based on protocol and study needs, including queries and dynamics
- Designs reports and metrics to assist with data cleaning and oversight of CDM vendor performance
- Performs User Acceptance Testing of the clinical database
- Authors or reviews and approves study specific CDM documentation (DMPs, CCGs, DTAs, EDC specifications)
- Monitors study progress to ensure successful achievement of study milestones
- May assist in oversight of CDM vendors
- Ensures that all CDM operations are conducted according to applicable Standard Operating Procedures (SOP)
- Assists in the identification of potential risks/challenges based on protocol, timelines, forecasts, and study metrics for the assigned studies. Assists the study team in the implementation of solutions
- Ensures CDM study documents are filed in the TMF (Trial Master File) in a timely manner
- Performs other duties as required
Qualification Requirements:
- Bachelor’s degree in health profession, science, or related field.
- Five years of CDM experience
- Knowledge of SOPs, GCP (Good Clinical Practice) standards, and CDM standards and systems
- Experience with EDC systems
- Advanced MS Excel skills (formulas, pivot tables); basic SAS or other programming is a bonus, but not required
- Excellent written and oral communication skills
- Excellent organizational skills and attention to detail
- Ability to prioritize and multitask
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.
