Senior Manager Clinical Affairs Process Improvement- 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.

Position Overview:

Responsible for strategy, management, execution and implementation for all divisional continuous improvement programs to drive excellence within the Global Clinical Affairs group in concordance with GCP, APOC quality and regulatory compliance. The role will work in close collaboration with the other functions within Clinical group such as Data Management, Statistics, Contracting, Logistics and Writing to deliver improvements from the application of process improvement methodologies and change management

Responsibilities:

• Experienced clinical leader responsible for identifying and leading the implementation of internal process optimization and system/process improvement programs including but not limited to: Developing tools, systems and dashboards to monitor effectiveness and enhance quality and efficiency in all areas of the Clinical group.
• Work cross-functionally with the Data Management team, Statistics team, Project Managers and CRAs to evaluate and streamline existing processes
• Continue to evaluate, develop and implement best practices across all functional areas of the group.
• Oversee compliance of clinical study sites selection, CRO selections and study monitoring
• Be proactive to provide risk mitigation strategies
• Accountable for delivering results from the application of continuous improvement methodologies and effective change management.
• Ensure close communication and working relationship with R&D, regulatory, quality, PMO and other functional teams
• Ensure compliance with GCP, quality and regulatory compliance and other APOC site specific compliances
• May lead a team of Clinical Affairs professionals.
• Responsible for hiring and retaining a diverse team, providing career coaching, growth and personal development. Accountable for staff development; instructs, mentors, evaluates and ensures staff is appropriately trained in processes and procedures, ensures established processes and procedures are being followed and documented. Accountable for the performance of subordinates and work output of managed subcontractors.
• Other miscellaneous duties as needed

Required Education and Experience:

• Master’s degree Science or Engineering is required, PhD is strongly preferred coupled with MBA
• A minimum of 15 years of experience in Clinical Research or related field
• A minimum of 5 years demonstrated people leadership experience and experience with budgetary responsibility.
• Experience across the areas of clinical, regulatory and quality (six-sigma) is a strong asset.
• IVD Experience preferred
• Knowledge of Six Sigma tools and process improvement techniques.
• Certification in process improvement methodologies strongly preferred
• Well-developed leadership track record in process improvement required
• Proven leadership and project management capabilities required
• Excellent communication skills (written and spoken)

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.

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