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 115,000 colleagues serve people in more than 160 countries.

About the role

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 management 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 and budget by utilizing the appropriate project management tools, selecting providers, managing vendor contracts and ensuring expenditures are within budgetary guidelines.
• Identifies resource needs and elevates/resolves resource constraints with management.
• 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, and 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.

Requirements

• Bachelor’s Degree (± 16 years), preferably in Life Sciences OR an equivalent combination of education and work experience.
• Minimum 5 years of medical devices, clinical research experience, or related industry.
• Prefer at least 3 years of related work experience in a Quality role in the medical device area and/or clinical trial environment.
• Prefer GCP audit experience.
• 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 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.

Benefits

• 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.

Pay

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.