Abbott Clinical Project Manager in Lake Forest, Illinois
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries.
The core function of the Project Manager, Clinical Research will entail the following:
Along with leadership team, the Project Manager, Clinical Research will manage a primary project of notable complexity and critical to the business, while assisting with other projects as needed, within budget and timelines. Responsible for providing guidance, leadership and development of junior staff.
Provide scientific, clinical, and/or medical expertise throughout the development and implementation of clinical studies. May write/manage/oversee clinical evaluations (plans and reports) or clinical study protocols, protocol amendments, clinical trial registrations and results postings, clinical study project timelines and scientific publications. Interacts with various cross-functional teams in order to contribute to clinical strategy, the development of plans, reports and project deliverables. Interacts with regulatory agencies as needed, and will use their scientific, clinical, and/or medical knowledge in order to provide directives to staff as well as study sites as directed by your manager.
Core Job Responsibilities
Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
A Clinical Project Manager should demonstrate excellent quality of work in the following activities:
Plans, develops, and manages clinical studies on new or existing products, ensuring that such studies are ethical, scientifically valid, and legally acceptable in order to meet both corporate and regulatory requirements and is responsible for the completion and approval of all contractual agreements involving clinical sites and any additional vendors, as applicable.
Plans for and manages a constant flow of activities directed toward project completion and coordinates monitoring system based on study schedules to ensure effective and efficient study completion. Includes coordination of activities with Clinical Operations, Biostatistics and Data Management.
Manages a team that may include Clinical Research Associates, Senior Clinical Research Associates,
and Clinical Research Assistants; hires, trains, and motivates personnel to meet departmental needs; schedules appropriate training sessions; and coaches career development.
Act as point person in working with outside vendors and research partners in contract development and negotiation.
Demonstrates and shares advanced knowledge of CFR, GCP, local regulations and internal procedures required for clinical trials.
Evaluates and interprets clinical research data to ensure timely and accurate data analysis and completion of final record and scientific presentation of study data in a way that fairly and accurately reflects study results.
Prepares Clinical Project Charters with associated budgeting and personnel requirements and ensures that assigned projects operate within scope and budget.
Set quality and compliance goals for the study and monitors/manages compliance as part of clinical project management.
Prepare and update study budget using existing tools and with input from Sr. Manager, Monitors spending against specific parts of trial budget.
Participates in appropriate in-house meetings to represent the department and remain abreast ofdevelopments relating to current and planned clinical programs.
Note: This job description is not to be considered an exhaustive statement of duties, responsibilities or requirements and does not limit the assignment of additional duties for this role.
Supervisory / Management Responsibilities
Exempts/ Non-Exempts/ Contingent: Contingent
Direct Reports: 3-5
Indirect Reports: 0
Accountable for successful execution of assigned clinical study within budget and in conformance with global regulations and internal policies and procedures. Scope includes development of clinical trial protocols, final.
records, clinical brochures, negotiation and execution of clinical site agreements. Position reports to Associate Director of Clinical Research.
In this role the Manager would have a specified range of interaction and scope of work within the business unit:
Be recognized by the project team as a leader, which would be reflected in the broadened scope of work and communication.
Communicate with associates across other departments (i.e., Regulatory, Legal, and R&D teams) and site leaders (i.e., Principal/Primary Investigators, Key Opinion Leaders, etc.)
Mentor more junior managers on certain aspects of the Manager role
Responsible for clinical study report planning, interpretation of study results and generation of study reports for products for registration and product approvals; coordinates with Biostatistics group to develop statistical plan and execution of analyses for investigational products; oversee generation of clinical study final reports by other Clinical Research personnel, as needed.
Demonstrate the ability to influence others to achieve positive results and collaboration through demonstrateddiplomacy and respect for others, provision of focus and appropriate prioritization, and facilitation of the decision-making process.
Work under general direction with the ability to solve a variety of problems of moderate scope and complexity against more general specifications.
Administer more latitude in determining how to arrive at a solution.
Exercise authority and judgment within defined limits to determine appropriate action, with the understanding that failure to achieve results, or erroneous decisions or recommendations may cause delays in trial schedules, data integrity or compliance, and may result in the allocation of additional resources
Identify objectives of an assignment, independently plan work, determine and develop the approach to a solution, and identify tasks that should be delegated.
Use excellent writing skills (i.e., content, logic, story, minimal redlines) and presentation skills (adept at handlingtough audience questions with poise; presents clear messages, demonstrates knowledge of subject) to communicate the logic and process of the solution.
Bachelor's Degree (life sciences or clinical research preferred) or equivalent combination of education and work experience.
Minimum Experience / Training
Advanced degree (MD, PhD, MS, MBA), minimum of 2 years clinical research experience, with a minimum of 2 years of management experience, or BS and a minimum of 5 years of clinical trial management experience.
Clinical research experience involving IVD devices is highly desirable. Advanced and up-to-date knowledge of clinical trial requirements, pertaining to clinical trial management is essential.
Project management certification preferred.
Must be detail-oriented and efficient in time management.
Must have excellent written and verbal communication, organizational and presentation skills.
Must be able to work effectively with others.
Self-directed and able to work within a fast paced and constantly changing environment.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email email@example.com
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