Senior Clinical Trial Associate, Pulmovant

Pulmovant

13h

About The Position

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. For more information, please visit https://www.pulmovant.com. About Roivant: Roivant specializes in developing transformative medicines at an accelerated pace through the launch of nimble biopharmaceutical and health technology entities, each meticulously tailored to address a specific medical need. Since its inception in 2014, Roivant has achieved the following critical milestones in support of its vision: built over 20 Vants; 12 consecutive positive Phase 3 trials; 8 FDA approvals; 5 successful IPOs; >$6B in capital raised; >$10B in global pharma partnerships and proceeds; and continued pipeline expansion across various modalities and therapeutic areas through in-licensing and acquisition of novel product candidates and technology platforms. In addition to a robust clinical stage pipeline, Roivant also incubates discovery-stage companies and health technology startups complementary to its biopharmaceutical business. Position: Senior Clinical Trial Associate Summary: 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.

Requirements

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
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%

Responsibilities

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