Veterans at Abbott
Abbott Clinical Project Manager in Santa Clara, California
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 103,000 colleagues serve people in more than 160 countries.
The Clinical Project Manager reports directly to the Senior Manager, Project Management
Basic Function :
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.
Essential job Responsibilities:
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 competencies :
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.
Minimum of Bachelor’s degree (health sciences field preferred)
Minimum of 2 years clinical project management experience (cardiovascular experience preferred)
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