Clinical Program Manager, Abbott Point of Care (Ottawa)

Job Description

At Abbott, we're committed to helping you live your best possible life through the power of health. For more than 130 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, 107,000 of us are working to help people live not just longer, but better, in the more than 160 countries we serve.

Abbott Point of Care is a worldwide leader in providing with-patient care solutions that are intuitive, reliable, and cost-effective for our customers. By delivering lab-quality results in minutes, our i-STAT® System family of with-patient products and services fosters a collaborative, patient-centered environment while driving operational performance. We are headquartered in Princeton, New Jersey, with more than 1,500 global employees and a presence in 84 countries. Our 46,500 square meter, state-of-the-art manufacturing facility, Abbott Point of Care, is located in Ottawa, Ontario, Canada.

Status: Full-Time/Permanent (Monday – Friday, 8:00am to 5:00pm)

Position Overview: The Clinical Program Manager is responsible for strategy, management and execution of the clinical studies / projects for regulatory submission or evidence generation within program(s).

Responsibilities:

Determines applicable program or study objectives, strategy, scope and schedule to meet business needs. Develops the project plan in consultation with the cross-functional program or project team, project stakeholders and the clinical team. Presents project plans, provides ongoing updates and presents project results to Division senior clinical management.

Manages and oversees the execution of the clinical program or projects (multiple clinical studies).

Ensures staff are trained on the requirements of the clinical project and the project plan.

Manages and directs the clinical team members (clinical project managers, CRAs) working on the clinical program.

Motivates and develops staff.

Responsible for ensuring the clinical project is audit-ready at all times (e.g. project team training records, central files, system validation, etc.)

Ensures adequate monitoring is conducted on all clinical projects.

Conducts clinical visits to support clinical projects.

Provides oversight of clinical project to ensure safety concerns and/or adverse events or trends in Field Events Reporting are identified and appropriate responses are developed an executed.

Controls device distribution and allocation.

Monitors project reports for accuracy and trending. Projects input to project budgets and project plans,

Provides 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.

Other miscellaneous duties as may be required.

Required Education and Experience:

Minimum of 7 years directly supporting clinical research or similar experience in a medical/scientific area

Minimum of 10 years managing projects and working with clinical professionals within a team as well as working in a cross-functional project development setting

High attention to detail and accuracy

Advanced written and oral communication skills

Able to manage multiple tasks and priorities

Proficient knowledge of medical terminology

Expertise with GCPs and regulatory compliance for clinical trials (e.g. applicable ISO Standards, FDA)

Strong problem-solving skills

Bachelor’s degree in Engineering, Science or related field

Advanced degree (Masters or Phd) is an asset

Abbott Canada is committed to the hiring, advancement and fair treatment of individuals without discrimination based on factors such as race, sex, colour, ethnic or national origin, religion, disability, age, citizenship, family or marital status, political beliefs, sexual preference or other factors included in human rights legislation.

Our diversity goals for recruitment, hiring, and retention are embedded in our corporate goals, and our diversity initiatives are supported by the highest level of the organization.

We strongly believe that a diverse workforce fosters more creative and innovative thinking throughout the organization. Creating an inclusive environment, where everyone is respected and valued, enables us to leverage our diversity as a business driver and strengthens our position as a global leader.

Abbott strives to promote and maintain an inclusive, high-performing culture that allows all employees to reach their full potential and contribute to Abbott’s success.

Join Our Talent Community to learn about upcoming job opportunities or connect with us at Abbott Canada, on LinkedIN, on Facebook and on Twitter @AbbottNews and @Abbott Global.