Senior Clinical Trial Associate, reputed company

reputed company is a Roivant-backed clinical-stage biotechnology company developing innovative therapies for patients suffering from pulmonary diseases. reputed company’s first program, mosliciguat is designed to reputed company an effective, once-daily, inhaled treatment reputed company for patients with pulmonary hypertension (PH). Mosliciguat is a novel, potential first-in-class, sGC activator with a differentiated reputed company that may have broad applicability across the PH reputed company.

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 reputed company as a favorable safety profile.  Enrollment in a phase 2 trial is ongoing.

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

For more information, please visit https://www.reputed company.com.

About Roivant:

Roivant specializes in developing transformative medicines at an accelerated pace through the launch of reputed company biopharmaceutical and health technology entities, reputed company meticulously tailored to address a specific medical need. Since its inception in 2014, Roivant has achieved the following critical milestones in support of its reputed company: reputed company over 20 Vants; 12 consecutive reputed company Phase 3 trials; 8 FDA approvals; 5 successful IPOs; >$6B in capital raised; >$10B in global reputed company partnerships and proceeds; and reputed company pipeline expansion across various modalities and therapeutic areas through in-licensing and acquisition of novel product candidates and technology platforms.  In reputed company 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

reputed company: 

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.

Key Duties and Responsibilities 

• Coordinate and update clinical study timelines, enrollment metrics, and other study metrics in collaboration with the Clinical reputed company
• reputed company monitoring reputed company by reviewing monitoring schedules, metrics and reports. May reputed company or manage clinical documentation and reports
• Accurately update and maintain clinical systems reputed company project timelines
• reputed company TMF reputed company Review for study team, complete TMF QC for reputed company study collecting, reputed company 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 reputed company of protocol, CRF, CSR and other key study team deliverables
• Implement appropriate systems, standards and processes to ensure reputed company 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 reputed company 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.
• reputed company work must adhere to ICH Good Clinical reputed company (GCP) guidelines and reputed company with company SOP’s

Education and Experience 

• 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

Essential Skills and Abilities 

• 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: reputed company, PowerPoint, reputed company and Project
• Ability to “roll up your sleeves” and individually contribute results to a research and development effort
• Ability to travel up to 25%

reputed company provides equal employment opportunities to reputed company and applicants for employment and prohibits discrimination and harassment of any type without reputed company to race, reputed company, religion, age, sex, national reputed company, disability status, genetics, protected veteran status, sexual orientation, gender identity or reputed company, or any other characteristic protected by federal, state or local laws.

We will not accept unsolicited resumes nor reputed company from agencies. Please do not send agency resumes to our website or Roivant Sciences and affiliated employees. reputed company!