Job at a glance
POSITION OVERVIEW The Site Operations Manager I is a member of the Clinical Operations department accountable for on-time and on-budget delivery of clinical studies using the highest quality standards. The Site Operations Manager I will have a broad therapeutic knowledge leading the multifunctional study management team within a matrix environment. The study management team is collectively responsible for planning, solutioning, recruiting, executing, and close-out of clinical studies, within the scope of the client agreement.
In doing so, the Site Operations Manager I will oversee all operational aspects of clinical trials according to and in compliance with corporate and project Standard Operating Procedures (SOPs), Good Clinical Practice (GCP)/International Conference on Harmonisation (ICH) guidelines and other applicable federal (FDA) and state regulations, to achieve established goals within timelines and budget. The Site Operations Manager I is the single point of contact to client study teams working with internal and external stakeholders.
This individual is accountable for the delivery of the project objectives on-time and on-budget and is responsible for end-to-end execution of clinical trials to ensure effective and timely internal and external communication of study progress, issues, and plans for resolution. The Site Operations Manager I is also responsible for efficient resourcing and financial management of studies under their supervision. DUTIES AND RESPONSIBILITIES Duties include but are not limited to: Project Guidelines and Communication: Develops a project management plan in conjunction with the appropriate cross-functional teams, outlining planning, execution, and closeout milestones in addition to communication and contingency plans Leads multi-disciplinary Study Management Team End-to-end management of clinical studies to ensure appropriate resourcing and timely and high-quality delivery by all functional areas.
Ability to identify and organize resources and services needed to accomplish tasks, sets objectives, plans for contingencies, and manages time effectively. Develops and monitors study metrics to continuously assess study progress Acts as the primary point of contact between Science 37 and sponsor project team, and independently leads internal and external project team meetings Project Analysis and Management Identifies critical project success factors for tracking, analysis and reporting including impact and probability of project risks Monitors and tracks study status, timelines, and budget expenditures; identifies opportunities and recommends implementation plan for efficiency measures Ensures timely data entry, query resolution and prompt resolution of data issues Coordinates assignment of needed resources for study conduct and completion with functional area leaders; ensures appropriate staffing to accomplish project goals within budget Identifies out-of-scope work and reports the scope change process to leadership Assists with the development of a budget/ contract change order as appropriate in conjunction with the Director, Clinical Operations, and the business development teams. Responsible for review of study budget, expense reports and financial records (invoicing/units/expenses) in conjunction with appropriate project team members Ensures that study activities are properly tracked and entered into the company’s time tracking/project management/resource planning software tool in a timely manner Ability to analyze data and information to derive conclusions and drive critical decision-making Assists and supports study audit preparations Leadership Accountable for development, oversight and delivery of team training for specific projects Applies expertise in day-to-day Clinical Operations activities, collaborates with internal and external cross-functional team members to develop study documents and manuals, including ICFs, manuals, presentation decks, risk plans, et