Associate Clinical Project Manager

About this role

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. JOB DESCRIPTION: Working at Abbott    

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life.  You’ll  also have access to:   

Career development with an international company where you can grow the career you dream of   

Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.   

An excellent retirement savings plan with high employer contribution   

Tuition reimbursement, the  Freedom 2 Save  student debt  program  and  FreeU  education benefit - an affordable and convenient path to getting a bachelor’s degree   

A company recognized as  a great place  to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune   

A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists   

For years, Abbott’s medical device businesses have offered technologies that are faster, more effective, and less invasive. Whether   it’s   glucose monitoring system, innovative therapies for treating heart disease, or products that help people with chronic pain or movement disorders, our medical device technologies are designed to help people live their lives better and healthier. Every day, our technologies help more than  10,000 people  have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than   500,000 people   with diabetes from routine   fingersticks .   

The Opportunity  

· Will be   required   to manage at least one primary project; Depending on scope and phase of project, may support multiple projects.    

· Provides project management   expertise   throughout the development and implementation of clinical studies. Interacts with various study support groups and the business unit   in order to   assist   in clinical strategy, the development of study plans, and project deliverables.    

· Is also assigned to other non-trial related activities such as process and procedure teams.    

· May support and mentor junior-level project managers.    

·   Facilitates   communication between R&D, Regulatory Affairs, Sales and Marketing, Training, Senior   Management   and investigational sites by conducting team meetings,   drafting   and sending routine correspondence (e.g., newsletters) and by presenting regular updates to   mgmt   staff.    

·   Facilitates   site selection process by conducting meetings with   appropriate departments   and individuals to review and revise draft site list as necessary, and by communicating the final site list to team members.    

· Manages clinical study timelines, budget by   utilizing   the   appropriate project   management tools, selecting providers, managing vendor   contracts   and ensuring expenditures are within budgetary guidelines.    

·   Identify   resource needs and elevates/ resolves   resource constraints with mgmt.    

·   Facilitates   regulatory submissions and communications by communicating with Regulatory Affairs during the submission process.    

·   Facilitates   the development of clinical strategy and trial design by conducting meetings with the   appropriate departments   and individuals to obtain feedback/direction.    

· Provides input to protocol design, case report form design, data management plan,   monitoring   plan.    

· Organizes Steering Committee meetings and communication; Coordinates investigator and research coordinator meetings.    

· Oversees compliance to study requirements; Reviews compliance to protocol and elevates critical protocol deviations    

· Works with Study Team to coordinate activities for all milestones; database locks, annual reports,   presentation   and publications    

· Provides study-specific training to internal team members and site personnel.  

Required Qualifications  

• Bachelors   Degree (± 16 years), Preferably in Life Sciences OR an equivalent combination of education and work experience  

• Minimum 5 years,   Medical   devices, clinical research experience, or related industry. Prefer at least 3 years   of  related   work experience in Quality role in medical device area and/or clinical trial environment. Prefer   GCP  audit   experience.  

• Specific requirements: Fluent in English, any   additional   major language is a preferred asset; Excellent Communicator; Computer Literate.  

Preferred Qualifications  

· Exercises authority and judgment to determine   appropriate action .    

·   Demonstrates   diplomacy and respect for others. Acts as a buffer for the team, providing focus and   appropriate prioritization . Facilitates decision making.    

·   Demonstrates   ability   to influence others to achieve positive results and collaboration.    

· Excellent knowledge of ISO and local regulations and   required   for clinical trials. Proven record of compliance with, and enforcement of, regulations in clinical trials.    

· Sets quality and compliance goals for the trial and monitors/manages compliance as part of clinical project management.    

· Develops   additional   project management tools to improve clinical trial performance.  

The base pay for this position is $90,000.00 – $180,000.00 In specific locations, the pay range may vary from the range posted.       JOB FAMILY: Clinical Affairs / Statistics DIVISION: MD Medical Devices LOCATION: United States > Sylmar : 15900 Valley View Court ADDITIONAL LOCATIONS:

WORK SHIFT:

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