Ph3Job Summary /h3 pThe Clinical Study Manager (CSM) will 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 CSM is a proven leader in clinical development with study management experience in the pharmaceutical or device industry. The CSM provides leadership and support to members of the multidisciplinary program teams, internally and externally, and can successfully thrive in a virtual clinical model. The CSM reports to the Senior Director of Clinical Operations and may be based at Liquidia’s headquarters in Research Triangle Park, North Carolina, or remote. /p h3Specific Duties, Activities, and Responsibilities /h3 ul liAct as a patient advocate throughout the clinical development project lifecycle, with a mindset to minimize patient and site burden when participating in clinical trials. /li liUnderstand and support trial milestones including site identification and assessment, patient/subject recruitment, Key Opinion Leader (KOL) and Steering Committee development, and medical affairs support as required. /li liCoordinate internally with Medical and Quality Assurance to identify risks to clinical trial projects. /li liParticipates in the development of study timelines, in coordination with the internal study team and external partners. Manages the trial according to agreed timelines. /li liDevelop Requests for Proposals for vendors (CRO, Bioanalytical Labs, Central Safety Labs, Data Management groups, etc.) required to support clinical studies. /li liAssist or lead the vetting of vendors and sites for study participation. /li liIn collaboration with Program Leaders, lead the development and updates of study specific protocols, consent forms, and other trial related materials (e.g., Study Monitoring Plan, Data Management Plans, CRFs, site training materials, Advertising Materials, etc.) as required. /li liOversee the work of CROs and other vendors (Central Labs, Clinical Supply Distributors, etc.) as assigned to clinical trials. /li liIdentifies potential risks to timelines, budgets, and quality, and participates in establishing and overseeing mitigation strategies with the internal team members and external partners, as applicable. /li liManage and track clinical trial budgets to include forecasting, review, and approval of vendor and site payments. The CSM is also responsible for notifying management of anticipated change orders and/or budget adjustments proactively. /li liAssumes primary accountability for assigned clinical trial execution according to protocol requirements, trial plans, company SOPs, ICH-GCP, FDA regulations, and applicable regulations in other regions. /li liCollaboratively work with the project team and other CRO/vendor resources and timelines associated with all study activities, including CRO/investigator agreements, central IRBs, database development and maintenance, monitoring strategy, QA audit plan, and coordination of Clinical Safety Review Teams when applicable. /li liSupports material planning and management to ensure appropriate execution of the clinical projects, including but not limited to distribution of documents, forms, supplies, equipment, and investigational product. /li liReviews reports from study data systems which show progress of data collection, source document verification, and query resolution. Reports untimely data entry to Program lead. /li liCollaborates with Program Lead and medical monitor to ensure adverse event review and coding review occur on the timelines detailed in study plans. /li liAssists 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. /li liEnsure the Trial Master File (TMF) is maintained and up to date and all documents are accounted for by completion of clinical study report. /li liGenerate compelling periodic trial Newsletters to communicate important trial aspects to trial sites. /li liEnsure the development and maintenance of trial-specific tracking systems to enable proper study management and monitoring activities, as required. /li liWork with the Senior Director of Clinical Operations, or similar to ensure that internal program team members are trained appropriately on study conduct. /li liServe as a liaison between external partners and internal team to ensure program specific information and ongoing updates are proactively communicated. /li liParticipates in the development, review, and implementation of departmental SOPs, processes, and initiatives. /li liAttend off-site meetings and conferences, as needed. /li liMentorship of junior colleagues in Clinical Operations and other departments in areas of oversight to foster development and expansion of junior colleague skill sets. /li /ul h3Education and Experience /h3 ul liBachelors with a minimum of five years of experience in clinical research, with at least two years of clinical project/study management. /li liExperience qualifying managing external vendors (e.g. CRO, Call Center, Central labs, etc.). /li liExperience managing clinical project team personnel. /li liExperience leading operational teams through the start-up, study conduct, data management, and report writing of clinical studies. /li liExperience liaising cross-functional teams internally and with external partners to align on program expectations. /li liExperience reviewing and editing protocols and clinical study reports. /li liDemonstrates knowledge of Good Clinical Practices and all applicable US regulations governing clinical research, as well as working knowledge of the FDA submission process. /li liExperience in Global clinical studies and country/region specific regulations governing clinical research outside of the US. /li liExcellent organization and communication skills, including experience dealing with decision makers such as physicians and IRB members. /li liDemonstrates problem-solving and interpersonal skills. Must have a ‘can-do’ attitude and a strong desire to take ownership of many different projects. /li liAbility to work independently and manage multiple timelines, while maintaining the team focus. /li liDemonstrated ability to exercise judgment and determine appropriate action to a variety of problems of varying complexity. /li liDemonstrated ability to manage multiple deadlines. /li /ul h3Knowledge, Skills and Abilities /h3 ul liStrong desire to join a small company and work in a fast-paced environment. /li liAbility to work with remote teams and to negotiate with external providers. /li liMust be detail oriented, highly organized, reliable, and accurate. /li liMust be a motivated self-starter, adaptable, and capable of working within a matrix environment. /li liMust display sound judgment and discretion as well as problem solving abilities especially within a team environment. /li liExperience with tools and systems for managing clinical trials (CTMS, TMF, EDC, ePRO database, Microsoft suite, etc.). /li liCompelling interpersonal verbal, written and presentation skills in communication with internal and external customers. /li liMust have the ability to accommodate international and domestic travel up to 30% at the request of the business. /li /ul /p #J-18808-Ljbffr