Clinical Project Manager

This position will manage clinical research projects, including key activities of landmark, global clinical trials, in a fast-paced environment with a focus on planning, execution and management of all operational aspects. Interfaces with the VP and Director, Clinical Affairs, and senior managers to provide tactical/operational leadership to members of the clinical study team, including cross-functional departments which support the clinical development process. [e.g., Clinical Research Associates (CRAs), Regulatory Affairs, Medical Affairs, Scientific Affairs, Biostatistics, Statistical Programming, Medical Writing, Data Management, Quality Assurance, Safety].

• Leads, executes, and monitors progress and performance of assigned clinical studies and programs globally, in accordance with strategy, project plans, and budget following applicable regulatory and standard operating procedures.
• Oversees the development of and collaborates with the study team on key team trial deliverables, such as protocols, informed consent documents, case report forms, trial guidelines, annual progress reports and final reports, including sponsor required regulatory submissions.
• Drives identification, qualification, and selection of clinical sites.
• Ensures clinical studies maintain a continuous state of audit readiness.
• Leads proactive identification, assessment, and management of clinical study risks.
• Informs and presents study progress and known risks to senior leadership.
• Selects and manages ongoing relationships with external vendors (i.e., CROs, core labs, central IRB, etc.) or contractors.
• Oversees contracts & other agreement for all aspects of assigned clinical studies.
• Oversees development of Clinical Monitoring Plan(s) and adequate monitoring of clinical study sites.
• Responsible for the conduct of site trial training and investigator meetings.
• Provides support to clinical investigators and site coordinators to resolve site-related issues.
• Manages day-to-day project activities of CRAs assigned to specific projects & provides project direction.
• Manages escalation of study related issues and establishes appropriate course of action/mitigation plans.
• Ensures adequate clinical data collection and follow-up compliance.
• Participates in study data review and interpretation, as well as oversight of clinical report writing.
• Thorough understanding of project management tools/techniques.
• Serves on various teams & represents the clinical department as needed.
• Participates in departmental developmental initiatives (e.g., training, SOP development, audit preparedness, etc.)
• Comprehensive knowledge of ISO (International Organization for Standardization), GCP (Good Clinical Practice), ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA (Food & Drug Administration) & other applicable regulations governing the conduct of clinical trials.

• Ability to remove roadblocks, manage study teams directly and indirectly to drive clinical studies and projects to on-time and within budget completions.
• Ability to gather information from multiple sources, analyze, integrate, and resolve any conflicting requirements, and drive the clinical affairs organization through any challenges to result in a successful clinical study.
• Regular and predictable work performance.
• Ability to work under fast-paced conditions.
• Ability to make decisions and use good judgment.
• Ability to prioritize various duties and multitask as required.
• Ability to successfully work with others.
• Ability to understand deliverables form cross-functional teams.
• Ability to manage clinical affairs cross-functional team without direct influence.
• Additional duties as assigned.