Senior Clinical Project Manager

Job Duties

• Leads and drives the project team in the planning, execution and management of all operational aspects of large-scale, complex, and/or business critical clinical trials.
• Leads, directs and executes clinical studies worldwide in accordance with strategy, project plans, approved budget and resource allocations following applicable regulatory and standard operating procedures.
• Tracks development of and collaborates with the project team on all internal and external project materials, processes, manuals, plans, committees, study systems and all sponsor required regulatory submissions.
• Owns and manages the clinical trial budget including developing the budget, forecasting, and accruals.
• Participates in the site qualification, activation and initiation process, including budget and contract management and review of site activation documentation.
• Ensures the project team maintains a continuous state of audit readiness.
• Prepares study related documents including clinical protocols, informed consent forms, case reports forms, monitoring plans, study manuals, and other study related tools.
• Assists in data management with query generation and resolution, and reporting of adverse events and protocol deviations.
• Assists with the development and implementation of site corrective actions as needed to address any compliance issues.
• Assists with study training for investigators and coordinators, contract research organization (CRO), Data and Safety Monitoring Board (DSMB) and/or Clinical Events Committee (CEC), or core labs.
• Manages partnership with CRO and other external vendors.
• In collaboration with the project team, leads the proactive identification, assessment, and management of clinical study risks.
• Informs and presents study progress and known risks to Senior Leadership.
• Assists in the planning of, and preparing materials for, investigator and coordinator meetings.
• Ensures that appropriate resources (personnel, tools, etc.) are maintained for Quality System compliance and audit readiness.
• May coordinate, schedule, and conduct monitoring visits at investigational sites to ensure compliance to the clinical protocol, regulations, and timely receipt of data including source document verification, writing or reviewing monitoring reports and follow up letters, and device accountability.
• Mentors and coaches all levels of the Clinical team.

Job Qualifications

Required: Bachelor's degree in health sciences or related field and Minimum of 5-7 years of clinical trial management experience or an equivalent combination of education and work experience.

• Able to communicate effectively, both orally and in writing, with excellent interpersonal and diplomacy skills and with high levels of emotional intelligence.
• Proficient computer skills: Electronic Data Capture, Microsoft Word, Excel, PowerPoint, MS Project.
• Strong organizational skills with high attention to detail and degree of accuracy.
• Skilled at collaborative and individual problem solving.
• Strong knowledge and understanding of Good Clinical Practices (GCP), FDA regulations, and current industry practices related to the conduct of clinical trials, which includes applicable ISO regulations for any trials conducted globally.
• Experience coordinating, prioritizing, setting timelines, and multi-tasking.
• Professional demeanor and appearance.
• Ability to expertly create and deliver communication to all levels of leadership with the appropriate level of detail for the audience.
• Demonstrate the ability to resolve conflict, influence teams, and build relationships in meeting organizational objectives without formal authority.
• Ability to work independently and manage multiple tasks in a fast-paced environment.
• Ability to work with and effectively manage cross-functional teams.
• Ability to travel domestically up to 40% of the time. Some international travel up to 10% may be expected.
• Experience managing scope, budget and timeline.
• Leadership ability to influence.
• Has consistently delivered projects with broad business impact across multiple teams.
• Has experience tackling challenging business problems that impact multiple teams.
• Financial acumen required.
• Clinical trial budget management experience required.
• Expertise with complex clinical research guidelines: 21CFR 312/812, ISO 14155, GDPR, GCP.

Preferred

• Previous experience with medical device trials, preferably as a sponsor.
• MS/MPH degree in life sciences, or related field.
• Participation on a product development (PDP) core team representing Clinical. Strongly preferred.