Job Title

Job Title - Clinical Trial Associate eTMF SpecialistReports to - Associate Director Clinical OperationsJOB PurposeThe Clinical Trial Associate supports the operational execution of clinical studies. This individual is responsible for the delivery of clinical studies according to agreed cost and timelines while ensuring patient safety and data integrity and quality per Ocugen and Industry standards.DUTIES AND RESPONSIBILITIESDevelops and directs clinical study and operational activities and manages their execution to ensure completion according to project timelines and budget.Leads the study execution team ensuring that studies are conducted in adherence to study protocols, applicable SOPs, ICH/GCP guidelines and government regulations.Reviews and contributes to development of protocols, amendments, case report forms and clinical study reports. Develops informed consents and may contribute to development of annual reports and investigational brochures.Manages TMF documents for all the studies from study startup to closeout and submission to regulatory agencies around the world.Manages the TMF documents for all the studies in audit issue free condition from the start up to close out and submission to regulatory agencies around the world.Efficiently communicates and collects all TMF necessary documents in a timely manner from the cross functional team so all the study documents in TMF are audit ready state in all phases of study conduct.Drives the identification, assessment, and qualification of clinical research sites. Ensures training of all investigational sites including planning of Investigator Meetings and development of stie training materials.Develops study operational documents which may include timelines, enrollment projections and study plans. Tracks performance relative to timelines and projections and ensures compliance with study plans.Works collaboratively with internal CRAs to ensure oversight of site initiation, interim monitoring, and site closure activities. Ensures the TMF is developed, maintained, reconciled, and archived.Assists in the identification and selection of CROs and clinical vendors. May manage the RFI and RFP process.Manages clinical vendors, including CROs including tracking of deliverables to ensure they are within timeline and budget.Provides study status updates to senior management and escalates study risks, as applicable.Works collaboratively with colleagues in Quality Assurance to develop and administer a study audit plan.Works collaboratively with colleagues in Finance to forecast, phase and manage study budgets.Ensures timely delivery of data for external safety board reviews as applicable.Proactively identifies risks, developing and implementing mitigation plans as applicable.May assist in developing policies and procedures (SOPs).Additional tasks and projects as requested.2. QUALIFICATIONSBachelor or master degree, in life sciences and related fields4+ years of progressive clinical research experience in the biotechnology/pharmaceutical industry is essentialExperience with eTMF, RTSM, CTMS and EDC are essential Must have CRO/vendor management experience.Experience in Ophthalmology and/or advanced therapy studies in Phases 1-3 highly desired.Strong knowledge of GCPs, ICH, and FDA regulatory requirements governing human clinical studies.Demonstrated attention to detail and outstanding organization skills.Self-motivated with a commitment to high quality, on-time deliverables.Excellent communication and collaboration skills with a team-oriented approach.Demonstrated ability to identify and resolve issues and effectively manage timelines.Veeva experience is preferred.3. WORKING CONDITIONSThis position operates in an office setting and may include 20% of travel to visit sites, vendors, or CROs. Job may require incumbent to be available outside of these hours to handle priority business needs.4. PHYSICAL REQUIREMENTSThis is a largely sedentary role.5.DIRECT REPORTSNA