Clinical Study Manager

Job Summary

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.

Specific Duties, Activities, and Responsibilities

• Act as a patient advocate throughout the clinical development project lifecycle, with a mindset to minimize patient and site burden when participating in clinical trials.
• Understand 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.
• Coordinate internally with Medical and Quality Assurance to identify risks to clinical trial projects.
• Participates in the development of study timelines, in coordination with the internal study team and external partners. Manages the trial according to agreed timelines.
• 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.
• In 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.
• Oversee the work of CROs and other vendors (Central Labs, Clinical Supply Distributors, etc.) as assigned to clinical trials.
• Identifies 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.
• Manage 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
• Assumes 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.
• Collaboratively 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.
• Supports 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.
• Reviews reports from study data systems which show progress of data collection, source document verification, and query resolution. Reports untimely data entry to Program 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 the Trial Master File (TMF) is maintained and up to date and all documents are accounted for by completion of clinical study report.
• Generate compelling periodic trial Newsletters to communicate important trial aspects to trial sites.
• Ensure the development and maintenance of trial-specific tracking systems to enable proper study management and monitoring activities, as required
• Work with the Senior Director of Clinical Operations, or similar to ensure that internal program team members are trained appropriately on study conduct
• Serve as a liaison between external partners and internal team to ensure program specific information and ongoing updates are proactively communicated
• Participates in the development, review, and implementation of departmental SOPs, processes, and initiatives.
• Attend off-site meetings and conferences, as needed.
• Mentorship of junior colleagues in Clinical Operations and other departments in areas of oversight to foster development and expansion of junior colleague skill sets.

Education and Experience

• Bachelors 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 operational teams through the start-up, study conduct, data management, and report writing of clinical studies.
• Experience liaising cross-functional teams internally and with external partners to align on program expectations.
• 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.
• Experience in Global clinical studies and country/region specific regulations governing clinical research outside of the US.
• Excellent organization and communication skills, including experience dealing with decision makers such as physicians and IRB members.
• 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.
• Experience with tools and systems for managing clinical rials (CTMS, TMF, EDC, ePRO database, Microsoft suite, etc.).
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• Compelling interpersonal verbal, written and presentation skills in communication with internal and external customers.
• Must have the ability to accommodate international and domestic travel up to 30% at the request of the business.
• Must be fluent in English