Clinical Study Manager
Liquidia is deeply passionate and committed to the discovery, engineering, and development required to bring novel therapies to patients who need them most, and to the healthcare providers who care for them. Our current drive is toward improving the treatment of pulmonary hypertension (PH). We will continue to combine our proprietary, innovative PRINT® Technology with new and established medications, offering the potential for both better precision and improved clinical outcomes. Our team members include some of the industry’s top scientists, clinicians, business strategists, engineers, and pharmaceutical executives. We work together to help people lead longer, healthier, and happier lives.
Liquidia is hiring a Clinical Study Manager (CSM) to be part of the Clinical Operations Department, which is responsible for planning, executing, managing, and closing studies associated with the company clinical development plans. The ideal candidate is a proven leader in clinical development with study management experience in the pharmaceutical or device industry. We are looking for a strong communicator who is passionate, engaging, and detail oriented as this role will be expected to balance strategic management of partners, vendors and sites, as well as tactically providing clinical study support internally and externally. The CSM will report to the Senior Director of Clinical Development and may be based at Liquidia’s headquarters in Research Triangle Park, North Carolina or remotely.
Principle Duties and Responsibilities
Vendor& Site Management
- Develop Requests for Proposals for vendors (CRO, Bioanalytical Labs, Central Safety Labs, Data Management groups, etc.) required to support clinical studies and serve as lead for vetting vendors and sites for study participation
- Serve as point of contact for CRO and vendor management
- Collaboratively work with the project team and other CRO/vendor resources and timelines associated with all study start-up activities, including CRO/investigator agreements, central IRBs, database readiness, monitoring strategy, QA audit plan, and coordination of Clinical Safety Review Teams when applicable
- Initiate and train sites to the study protocol. Ensure proper site adherence to clinical research regulations.
Clinical Operations Management & Support
- Understand and support global program goals including site identification and assessment, patient/subject recruitment, Key Opinion Leader (KOL) and Steering Committee development, and medical affairs support
- In collaboration with Program Leaders, lead the development of study specific protocols, consent forms, and other trial related materials (e.g., Study Monitoring Plan, Data Management Plans, Advertising Materials, etc.)
- Follow approved clinical study protocols and help the project leader maintain operational plans, which are consistent with strategic corporate and R&D objectives and support the project lead in primary accountability for the ongoing progress of those plans on assigned studies
- Coordinate with Medical and Quality Assurance to identify risks to clinical study projects
- Plans for and manage all materials to support the appropriate execution of the clinical projects, including but not limited to distribution of documents, forms, supplies, equipment, and investigational product
- Reviews reports from study data systems which show progress of data collection, source document verification, and query resolution. Reports untimely data entry to project lead
- Collaborates with Program Lead and medical monitor to ensure adverse event review and coding review occur on the timelines detailed in study plans.
- Assists with review of study data reports during the cleaning phase of a study (i.e. prior to interim analysis or database lock) and aligns with team on any issues needing escalation
- Ensure Trial Master File (TMF) is updated on an ongoing basis and all documents are accounted for by completion of clinical study report.
- Ensure the development and maintenance of program-specific tracking systems to enable proper study management and monitoring activities, as required
- Ensure operational and regulatory integrity of assigned studies and participates in FDA or other regulatory authority inspections, as needed
Liquidia offers a competitive compensation package (base salary and commission) as well as a comprehensive benefits package that includes Medical, Dental, Vision, STD, LTD, 401(k) Savings Retirement Plan, ESPP, Unlimited Paid Time Off and more!
Liquidia is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. Reasonable accommodation may be made to enable qualified individuals with disabilities to perform the essential functions of this position.
Recruiting Agencies, Please Note:
Liquidia will not accept unsolicited assistance from recruiting/search agencies for this employment opportunity. Please, no phone calls or emails. All resumes submitted by recruiting or search agencies to any employee at Liquidia via email, the Internet or in any form and/or method without a valid written search/recruitment agreement in place for this position will be deemed the sole property of Liquidia. No fee will be paid in the event the candidate is hired by Liquidia as a result of the referral or through other means.