Associate Clinical Project Manager

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 114,000 colleagues serve people in more than 160 countries.

The Opportunity

The Associate Clinical Project Manager is responsible for managing and meeting the objectives of clinical projects. Internally interfaces with data management, biostatistics, regulatory, clinical research associates, Finance, field clinical specialists, and cross-functional team.

What You Will Do

• Assists in the management and execution of applicable clinical projects.
• Responsible for ensuring the clinical project is always “audit ready” (project team training records, central files, system validation, etc.).
• If applicable, ensures adequate monitoring is conducted on all clinical projects.
• Conduct clinical visits as needed to support applicable clinical project.
• Enlists support and specifies tasks for various team members to assure meeting objectives are completed on schedule.
• Provides oversight clinical projects to ensure safety concerns and/or adverse events or trends in Field Events Reporting are identified and appropriate responses are developed and executed.
• Provides clinical input and support for planning post-project activities and product market launch.
• Monitors project reports for accuracy and trending. Provides input to project budgets and project plans.
• Provide clinical scientific support to project teams.
• Evaluates clinical data in preparation of study summary reports for presentations, publications, and submissions.
• Develops and implements corrective actions as needed to address any noncompliance issues.
• Communicates with and provides updates to specific core teams.
• Oversees activities delegated by Clinical Research Manager or Director, Clinical
• Working under general supervision, is responsible for various duties related to Negotiating contracts and budgets with research sites, ensure contracts are written in accordance to associated Abbott and regulatory protocols, obtain necessary approvals from senior management for clinical agreements. Handling and oversite of Clinical site payments /financials associated with Clinical studies.
• Populates, compiles, and verifies required agreements (based on templates approved and provided by Legal) to ensure timely clinical trial start and compliance to internal and external regulations.
• Negotiates Master Clinical Trial Site Agreements (“MCTSA”), Facility Use Agreements, Statements of Work and accompanying amendments, and assignments.
• Coordinates with Legal the modification and assembly of the agreements and documents referenced above.
• In conjunction with Legal department, ensures agreements and related documents are compliant to Legal, regulatory and company guidelines.
• Tracks, routes, and files Financial and regulatory documents in designated area.
• Track clinical studies’ accruals and spending to ensure adherence to study budgets and Funding approvals.
• Review and approve invoices related to ongoing clinical projects.
• Communicate clinical affairs accrual and spending and financial metrics to appropriate business entities.
  
  

Experience And Background

Bachelor’s degree in engineering, biological sciences, or related medical/scientific field. Advanced degree is preferred.

A minimum of 8 years of experience in conducting clinical studies or related laboratory skills. 1-3 years’ experience managing projects and working with clinical professionals within a team, as well as working in a cross-functional product development setting.

Experience in medical device related studies is desirable.

High attention to detail and accuracy. Advanced written and oral communications skills. Able to manage multiple tasks. Proficient knowledge of medical terminology. Expertise with GCPs, and regulatory compliance guidelines for clinical trials (e.g. applicable ISO Standards, FDA). Strong problem-solving skills.

Strong computer skills. Demonstrated ability to work effectively on cross-functional teams. Able to travel as needed (

Must have demonstrated strong written and verbal communication, interpersonal, presentation, analytical, organizational, technical writing, and problem-solving skills. Able to interpret clinical data, meet deadlines and work effectively with all levels of employees.

Proficiency in Microsoft Office Suite and relevant clinical applications.

The base pay for this position is $98,000.00 – $196,000.00. In specific locations, the pay range may vary from the range posted.