About

• 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 Associate Clinical Document Manager will oversee trial master file (TMF) activities internally and externally with vendors. This position oversees TMF planning, set-up and maintenance activities including inspection readiness and remediation to ensure adherence to established industry processes and compliance with applicable global regulations.

Principal Duties and Responsibilities include the following

• Maintain internal data repositories for storage of departmental level information.
• Maintain current knowledge of the CDISC Trial Master File Reference Model, industry best practices and regulatory considerations.
• Ensure clinical trial documentation is consistent with TMF specifications, applicable SOPs (Standard Operating Procedures), ICH/GCP guidelines and other regulatory agency requirements.
• Collaborate in developing and maintenance of TMF SOPs and creating relevant training materials.
• May provide TMF educational workshops and training.
• Serve as eTMF systems administrator/supervisor and interface with eTMF vendor as superuser. Address TMF user questions and provide reporting support.
• Collaborates with trial execution teams on the proper use of repositories (Egnyte/TEAMS/TMF) and eTMF systems.
• Assist eTMF implementation/set-up activities with trial management and contribute to TMF Plan review.
• Collaborate with trial team to ensure the TMF is ‘inspection ready’ throughout the lifecycle of a trial by conducting inspection readiness assessments, consistency checks.
• Reports metrics to trial management as applicable to monitor and identify study specific TMF trends and escalate concerns to trial management lead.
• Facilitate communication of issues to applicable representatives to ensure documents that fail TMF quality requirements and/or TMF inspection readiness review are effectively remediated.
• Provide TMF status reports at study team meetings, participates in collaborative efforts and plays an important cross-functional role in TMF document retrieval and management.
• Coordinate and track the long-term storage /archival location of original documents.

Qualification Requirements

• BS/BA degree required
• Minimum 4 years clinical research experience with 2 years relevant document management experience
• Must be knowledgeable in domestic and global regulatory requirements and guidance’s
• eTMF experience required, including experience in study start-up, maintenance, close-out, and performing quality control and comprehensive completeness reviews
• Knowledge and application of ALCOAC standard, Good Clinical Practice, Good Documentation Practices, and International Council for Harmonization E6(R3) guidelines
• Knowledge of clinical study file documents, TMF Reference Model, clinical trial activities, and terminology
• Willingness to learn/manage and navigate multiple electronic TMF systems
• Computer literacy/ proficiency in MS Office suite, TEAMS, SharePoint etc.
• Ability to maintain a high level of accuracy and attention to detail in fast-paced environment with shifting priorities
• Approachable and builds constructive, positive, collaborative relationships with key internal stakeholders and external vendors
• Must be proactive, self-motivated, and able to work independently with minimal supervision
• Ability to work virtually
• Some travel may be required for educational seminars and departmental meetings. Ability to travel approximately 5%.
• 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.