Clinical Study Manager

Liquidia•,

6h•Hybrid

About The Position

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 Senior Director of Clinical Operations and may be based at Liquidia’s headquarters in Research Triangle Park, North Carolina, or remote.

Requirements

Bachelor’s with a minimum of five years of experience in clinical research, with at least two years of clinical project/study management.
Experience qualifying & managing external vendors (e.g. CRO, Call Center, Central labs, etc.)
Experience managing clinical project team personnel.
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 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.
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 international and domestic travel up to 30% at the request of the business.

Responsibilities

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.
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, CMC, PRINT Teams, and Quality Assurance management 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.
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
Plans for and manages 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.
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 maintenance of program files according to applicable regulations, guidelines, and corporate policy (e.g. GCPs and company SOPs)
Ensure Trial Master File (TMF) is updated on an ongoing basis, and all documents are accounted for by completion of clinical study report.
Perform, on a regular basis (e.g. quarterly), quality checks of the TMF.
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 participate in FDA or other regulatory authority inspections, as needed.
Work with the Director of Clinical Operations to ensure that internal program team members are trained appropriately on study conduct.
Serve as a liaison between vendors and internal team to ensure program specific information and ongoing updates are proactively communicated.
Draft and send periodic study Newsletters.
Attend off-site meetings and conferences, as needed.