[Hiring] Senior Clinical Trial Associate @Pulmovant

Role Description

Assist in managing the day-to-day operations of assigned studies to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements.

• Coordinate and update clinical study timelines, enrollment metrics, and other study metrics in collaboration with the Clinical Lead
• Provide monitoring oversight by reviewing monitoring schedules, metrics and reports. May oversee or manage clinical documentation and reports
• Accurately update and maintain clinical systems within project timelines
• Oversee TMF Quality Review for study team, complete TMF QC for each study collecting, quality review and submitting documents to the TMF
• Performing QC of TMF as appropriate
• Participate in developing study plans and system set-up; participate in preparation and ensure operational excellence of protocol, CRF, CSR and other key study team deliverables
• Implement appropriate systems, standards and processes to ensure quality at the level of investigative sites, vendors and data; maintain clinical study files per ICH guidance
• Participate in preparation of vendor requirements and project scope and selection of study vendors; effectively manage interactions with vendor study team
• Work on study feasibility assessments and selection of countries and sites for study conduct
• Review and track study invoices against executed scope of works
• Support planning and logistics for meetings including investigator meetings, study team meetings, and meetings with CROs and other vendors
• Generate, finalize and distribute study team agendas and meetings
• All work must adhere to ICH Good Clinical Practice (GCP) guidelines and comply with company SOP’s

Qualifications

• BA/BS degree with at least 2 - 4 years’ clinical trial management experience, or advanced degree (MS) with at least 2 years’ clinical trial management experience
• Must have strong knowledge of ICH/GCP guidelines
• Must have strong knowledge of protocol and clinical drug development processes, clinical study design, study planning and management, and monitoring
• Strong experience in management of CROs and other vendors

Requirements

• Proven project management skills and study leadership ability required
• Must have excellent interpersonal, written and verbal communication skills, and administrative skills
• Excellent computer skills in the following programs: MS Word, PowerPoint, Excel and Project
• Ability to “roll up your sleeves” and individually contribute results to a research and development effort
• Ability to travel up to 25%

Company Description

Pulmovant is a Roivant-backed clinical-stage biotechnology company developing innovative therapies for patients suffering from pulmonary diseases. Pulmovant’s first program, mosliciguat is designed to provide an effective, once-daily, inhaled treatment option for patients with pulmonary hypertension (PH).

Mosliciguat is a novel, potential first-in-class, sGC activator with a differentiated mechanism that may have broad applicability across the PH spectrum.

Mosliciguat has been extensively characterized across a robust Phase 1 program with 170 participants dosed to date including patients with PH in the Phase 1b ATMOS study which has produced highly compelling and clinically meaningful efficacy data, as well as a favorable safety profile. Enrollment in a phase 2 trial is ongoing.

As part of the Roivant family of companies, Pulmovant leverages the power of collaboration and innovation to drive progress.