Abbott Senior Project Manager, Clinical Research in Santa Clara, California
At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.
We are recruiting an experienced Senior Project Manager to support our Clinical Research division.
The selected candidate will be responsible for global project management of clinical trials projects and will interact with all Abbott four business units. As a Clinical Project Manager, you will provide project management expertise throughout the development and implementation
of clinical trials projects. You will interact with various study support groups and the business unit in order to assist in clinical strategy, the development of study project plans and project deliverables.
Facilitating site selection process by conducting meetings with appropriate departments and individuals to review and revise draft site list as necessary
Managing clinical project timelines, budget by utilizing the appropriate project management tools, selecting providers, managing vendor contracts and ensuring expenditures are within budgetary guidelines
Facilitating regulatory submissions and communications
Facilitating the development of clinical execution strategy by conducting meetings with the appropriate departments and individuals to obtain feedback/direction
Overseeing compliance to study requirements
Develop project plans/budgets and manage Japan Foreign Data Submissions
Develop project plans/budgets and facilitate Label Expansion projects using non-standard clinical data sources.
Facilitate Process Improvement, Standardization and Information Sharing Projects for Project Management group
Required skills and experiences:
Ability to apply clinical trial knowledge and experience to new project paradigms to ensure GCP compliance while minimizing the clinical project requirements
Completed Bachelor’s degree. Degree preferred in biological sciences or related medical/scientific field.
Proven experience in project management with 1 to 3 years of experience
Minimum 3 years’ experience in clinical trial management
Fluency in English (any other language is an asset)
Flexibility combined with excellent interpersonal skills
Ability to influence others to achieve positive results and collaboration
Good knowledge of FDA regulations for clinical trials and OUS knowledge is helpful
Knowledge of clinical trials in medical device or other industry preferred and outcomes research study design
Demonstrated ability to work effectively on cross-functional teams.
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 firstname.lastname@example.org