Clinical Study Manager

Job not on LinkedIn

🔥 3 minutes ago

🌲 North Carolina – Remote

🌲 North Carolina – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧪 Clinical Research

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

Liquidia Corporation

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2004

🧬 Biotechnology

💊 Pharmaceuticals

💰 $75M Post IPO equity on 2024-02

Biotechnology • Pharmaceuticals

Liquidia is a biopharmaceutical company focused on developing inhaled therapies for rare cardiopulmonary diseases, particularly pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). The company leverages its proprietary PRINT® particle engineering technology to create proprietary formulations and delivery methods aimed at improving efficacy, tolerability, and convenience of inhaled medicines; its pipeline includes inhaled treprostinil (commercial product) and clinical-stage candidates such as L606. Liquidia emphasizes patient support, clinical development, and advancing therapies for improved respiratory outcomes.

📋 Description

• Act as a customer advocate throughout the clinical development project lifecycle • Support global program goals, including site identification and assessment, patient/subject recruitment, KOL and Steering Committee development, and medical affairs support • Lead development of study-specific protocols, consent forms, monitoring plans, data management plans, advertising materials, and other trial materials • Develop requests for proposals for CROs, laboratories, data management groups, and other vendors • Assist with or lead vetting of vendors and study sites • Manage CROs and other vendors supporting clinical studies • Develop, manage, and track clinical trial budgets, including vendor and site payments • Proactively notify management of anticipated change orders and budget adjustments • Support operational plans and ongoing progress of assigned studies • Coordinate with Medical, CMC, PRINT Teams, and Quality Assurance management to define study goals and scope • Initiate and train sites on study protocols and ensure regulatory adherence • Coordinate study start-up activities, agreements, IRBs, database readiness, monitoring strategy, QA audit plans, and Clinical Safety Review Teams • Manage materials required for clinical project execution, including documents, forms, supplies, equipment, and investigational product • Review study data-system reports covering data collection, source document verification, and query resolution • Assist with study data review during cleaning phases and escalate issues as needed • Maintain program files and ensure ongoing Trial Master File updates and document completeness • Perform regular TMF quality checks • Maintain program-specific tracking systems for study management and monitoring • Ensure operational and regulatory integrity and participate in FDA or other regulatory authority inspections as needed • Ensure internal program team members are appropriately trained on study conduct • Liaise between vendors and internal teams to communicate program information and updates • Draft and send periodic study newsletters • Attend off-site meetings and conferences as needed

🎯 Requirements

• Bachelor’s degree with a minimum of five years of experience in clinical research, including at least two years of clinical project/study management • Experience qualifying and managing external vendors, including CROs, call centers, and central laboratories • Experience managing clinical project team personnel • Experience leading program operational teams through study start-up, conduct, data management, and clinical study report writing • Experience reviewing and editing protocols and clinical study reports • Knowledge of Good Clinical Practices and applicable US regulations governing clinical research • Working knowledge of the FDA submission process • Strong understanding of clinical trial budget/resource forecasting and management • Excellent organization and communication skills, including experience with physicians, IRB members, and FDA staff • Problem-solving and interpersonal skills • Ability to work independently and manage multiple timelines and deadlines • Ability to exercise judgment and determine appropriate action for problems of varying complexity • Ability to work with remote teams and negotiate with external providers • Detail-oriented, highly organized, reliable, and accurate • Motivated self-starter, adaptable, and capable of working within a matrix environment • Strong computer skills, including Microsoft programs and project management software • Strong verbal, written, and presentation skills • Ability to accommodate international and domestic travel up to 30% at the request of the business

🏖️ Benefits

• Competitive compensation package • Medical insurance • Dental insurance • Vision insurance • Short-term disability (STD) • Long-term disability (LTD) • 401(k) Savings Retirement Plan • Employee Stock Purchase Plan (ESPP) • Equal opportunity employment • Reasonable accommodation for qualified individuals with disabilities