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Job: Clinical Study Manager, Liquidia Technologies, Morrisville, NC
Clinical Study Manager
Morrisville, NC 27560 United States
Liquidia Technologies is a biopharmaceutical company transforming the development of new therapies by precisely engineering drug particles. Our proprietary PRINT technology is a simple, elegant solution that solves common problems with drug delivery and efficacy. PRINT technology is a scalable cGMP compliant process that creates particles and can apply to virtually any therapeutic area, molecule or route of administration. Liquidia is bringing more efficient, controlled development capabilities to the industry while enhancing the safety and quality of products for patients. Liquidia is advancing product candidates from its own pipeline. These initial product candidates, LIQ861 and LIQ865, apply the PRINT technology to better drug delivery in inhaled and pain therapeutic areas, respectively. The PRINT technology is also licensed with world-leading pharmaceutical companies that are developing future product candidates.
Summary of Major Responsibilities:
The 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 Executive Director of Clinical Operations and is based at Liquidia’s headquarters in Research Triangle Park, North Carolina.
Responsibilities include but are not limited to:
Act as a customer advocate throughout the clinical development project lifecycle.
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 as required.
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.) as required.
Develop Requests for Proposals for vendors (CRO, Bioanalytical Labs, Central Safety Labs, Data Management groups, etc.) required to support clinical studies.
Assist or lead the vetting of vendors and sites for study participation
Manage the work of CROs and other vendors (Central Labs, Clinical Supply Distributors, etc.) as assigned to clinical studies.
Develop, manage, and track clinical trial budgets to include review and approval of all vendor and site payments. The CSM is also responsible for notifying management of anticipated change orders and/or budget adjustments proactively.
Implement approved clinical study protocols and operational plans, which are consistent with strategic corporate and R&D objectives and assumes primary accountability for the ongoing progress of those plans on assigned studies.
Coordinate with Medical, CMC, PRINT Formulation, and Quality Assurance teams, to identify goals and scope of clinical study projects.
Initiate and train sites to the study protocol. Ensure proper site adherence to clinical research regulations.
Manage 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.
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.
Ensure maintenance of program files according to applicable regulations, guidelines, and corporate policy (e.g. GCPs and company SOPs).
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.
Work with the Executive Director of Clinical Operations to ensure that internal program team members are trained appropriately on study conduct.
Serve as a liaison between clients and internal team to ensure program specific information and ongoing updates are proactively communicated.
Manage study and program budgets
Attend off site-meeting and conferences, as needed.
Bachelor’s degree with a minimum of five years of experience in clinical research, with at least two years of clinical project/study management require
Phase II and Phase III clinical study management, CRO oversight, and monitoring experience required
Experience qualifying & managing external vendors (e.g. CRO, Call Center, Central labs, etc.)
Experience managing clinical project team personnel strongly preferred
Experience leading program operational teams through the start-up, study conduct, data management, and report writing of clinical studies.
Experience reviewing and editing protocols and clinical study reports.
Demonstrates knowledge of Good Clinical Practices and all applicable US regulations governing clinical research, as well as working knowledge of the FDA submission process.
Strong understanding of clinical trial budget/resource forecasting and management
Excellent organization and communication skills, including experience dealing with decision makers, such as physicians, IRB members, and FDA staff.
Demonstrates problem-solving and interpersonal skills. Must have a ‘can-do’ attitude and a strong desire to take ownership of many different projects.
Ability to work independently and manage multiple timelines, while maintaining the team focus.
Demonstrated ability to exercise judgment and determine appropriate action to a variety of problems of varying complexity.
Demonstrated ability to manage multiple deadlines.
Knowledge, Skills and Abilities
Strong desire to join a small company and work in a fast-paced environment
Ability to work with remote teams and to negotiate with external providers
Must be detail oriented, highly organized, reliable, and accurate
Must be a motivated self-starter, adaptable, and capable of working within a matrix environment
Must display sound judgment and discretion as well as problem solving abilities especially within a team environment
Strong computer skills, including Microsoft programs and project management software
Compelling interpersonal verbal, written and presentation skills in communication with the internal and external customers
Must have the ability to accommodate 30% international travel and 10% domestic travel at the request of the business
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