Title: Clinical Research Project Manager
Location: Naples, FL
The Clinical Research Project Manager Associate is responsible for managing and resolving issues related to the time, budget, and resource allocation for clinical studies. The Clinical Research Project Manager Associate will track timelines, developing budgets, oversee study progress, interacting with all aspects of the study team (data management, monitoring, medical writing, biostatistics, etc.).
Essential Duties and Responsibilities:
Under supervision of direct manager, works to lead a project team conducting assigned clinical research studies.
Moves project forward while ensuring quality, timelines, and budget management.
Coordinates activities and deliverables with all study conduct partners and is accountable for all project deliverables for each project assigned.
Prepares high-level budget estimates in response to internal study requests followed by detailed budget proposals.
Ensures accurate trial budget management, updates for scope changes, and reconciliation of assigned trials.
Drive study compliance by maintaining and updating trial management systems, using study tools and management reports available to analyze trial progress.
When necessary, escalates corrective and preventive actions (CAPA) when the trial deviates from plans and communicates study progress and issues to study management teams, business partners, and clinical research leadership.
Ensures accurate finance reporting and trial delivered within budget by adhering to finance reporting deliverables and timelines.
Development and implementation of project plans.
Prepare project management reports for research management.
Expected to be proactive in managing projects and in communications with key stakeholders around attaining project goals, deliverables, timelines, budget, and quality
Utilizes Workfront templates/processes and other tools for work management
Works to improve processes and solve routine problems of limited scope and complexity following established policies and procedures
The above statements describe the general nature and level of work being performed in this job. They are not intended to be an exhaustive list of all duties, and indeed additional responsibilities may be assigned, as required, by management.
Education and Experience:
5 years of clinical research experience is required.
1 year project management experience required.
Bachelor’s Degree required, preferably in life sciences or another relevant field.
Experience working for a medical device manufacturer, pharmaceutical manufacture, or clinical research organization (CRO) is required.
Direct orthopedic therapeutic area expertise is preferred.
Experience with multiple study types, including real-world evidence (RWE), post-marketing, interventional, and observational is preferred.
Knowledge and Skill Requirements/Specialized Courses and/or Training:
Strong knowledge of Good Clinical Practice/ICH guidelines and applicable regulatory and ethical requirements.
Strong organizational skills and ability to manage time and work independently.
Ability to embrace new technologies.
Excellent communication, presentation, interpersonal skills, both written and spoken.
Strong technology skills in project management and clinical trial software.
Ability to effectively communicate project planning requirements to all stakeholders, including task assignments, duration, and resource requirements.
Strong strategic thinker, excellent collaboration, and careful attention to detail.
Awareness of orthopedic surgery principles, theories, and products preferred.
Strong accountability to project deliverable timing and budgets required.
Continuously seeking ways to improve complex systems of people and processes
Machine, Tools, and/or Equipment Skills:
PC, database, research tools, internet research tools.
All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
To apply for this position or to learn more, please click "Apply Online" below.
SOCRA Exp: 2/1/2022