Abbott Clinical Systems Project Manager II in Santa Clara, California
Abbott is a global healthcare company devoted to improving life through the development of products and technologies that span the breadth of healthcare. With a portfolio of leading, science-based offerings in diagnostics, medical devices, nutritionals and branded generic pharmaceuticals, Abbott serves people in more than 150 countries and employs approximately 73,000 people. Please note that candidates need to be eligible to work in the U.S. without Abbott sponsorship.
Primary Job Function:
The core function of the Clinical Project Manager II (CPM II) will entail the following:
Handling a primary project of notable complexity and critical to the business, while assisting with other projects as needed. Examples of a primary project would include managing end to end deployment of a system or solution to support latest industry innovation.
Command management of multiple projects, in addition to acting as a consultant to business units and other teams, based on demonstrated proficiency in all areas of clinical project management.
Core Job Responsibilities:
Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
A CPM II should demonstrate excellent quality of work in the following activities:
Demand high standards of performance from project team;
Lead risk management activities by working with team to identify risks to systems/solution implementation and outcomes, present findings to management, and implement basic mitigation;
Act as point person in working with outside vendors and research partners such as EDC vendors, angiographic/IVUS/clinical core labs in contract development and negotiation;
Excellent knowledge of CFR, GCP, local regulations and internal procedures required for clinical trials;
Proven record of compliance with, and enforcement of, regulations in clinical trials;
Set quality and compliance goals for the projectl and monitors/manages compliance as part of clinical project management;
Prepare and update project budget using existing tools and with input from manager;
Monitors spending against specific parts of project budget;
Ensure compliance with applicable Corporate and Divisional Policies and procedures.
Position Accountability / Scope:
In this role the CPM II would:
Be recognized by the project team as a leader, which would be reflected in the broadened scope of work and communication
Interact with the immediate supervisor and Clinical Development team members locally and internationally as required. Will need to have in-depth knowledge of business in order to understand the issues and propose an appropriate solution
Communicate with associates across other departments (i.e., Marketing, Legal, and R&D teams) and site leaders (i.e., Principal/Primary Investigators, Key Opinion Leaders, etc.)
Mentor more junior CPMs on certain aspects of the CPM role
Demonstrate the ability to influence others to achieve positive results and collaboration through demonstrated diplomacy 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 project schedules, 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
Complete work is reviewed upon completion for adequacy in meeting objectives
Use excellent writing skills (i.e., content, logic, story, minimal redlines) and presentation skills (adept at handling tough audience questions with poise; presents clear messages, demonstrates knowledge of subject) to communicate the logic and process of the solution
Systems experience such as CTMS, CDC, EDC, IVRS, any applicable clinical research systems highly preferred
Bachelor’s degree required, or an equivalent combination of education and work experience. Master's degree preferred.
Minimum Experience / Training Required:
Advanced degree (MD, PhD, MS, DVM) and 2-3 years clinical trial experience, or
BS and minimum of 3+ years clinical trial experience, or
3-5 years clinical trial management experience and has experience in cardiovascular area.
Superior knowledge of clinical trial requirements, patient treatment modalities/risks, and full working knowledge of Abbott Vascular processes pertaining to clinical trial management.
(Optional) University certification in project management with advanced coursework or certified associate in project management (CAPM).
JOB FAMILY: Clinical Research-General
DIVISION: AVD Vascular
LOCATION: United States - California - Santa Clara
WORK SHIFT: Standard
TRAVEL: Yes, 10 % of the Time
MEDICAL SURVEILLANCE: Yes
SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.
EEO is the Law link - English: http://188.8.131.52/content/common/External/EEO_English.pdf
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Abbott is about the power of health. For more than 125 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 150 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health.
The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges.
We invite you to explore opportunities at Abbott , to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.