Abbott Field Clinical Specialist – Clinical Affairs (Western Canada) in Vancouver, British Columbia
At Abbott, we're committed to helping you live your best possible life through the power of health. For more than 125 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, 94,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.
Status : Regular, Full Time
Territory : Western Canada (British Columbia, Alberta, Saskatchewan and Manitoba). The candidate should be based in either Alberta or British Columbia.
Position Overview :
Assist with execution of all aspects of Clinical Study activities.
Attend and provide technical support and direction to physicians for all study related procedures in operating, procedure rooms, and clinic areas.
Works with physician KOLs on all aspects of Abbott sponsored studies.
Works independently and with the teams to identify and develop sites and investigators capable of delivering required data quality and study participation levels.
Develops and maintains knowledge of clinical sites in the assigned territory to best understand and assess investigators’ interests and capabilities as defined by study specific requirements and by the applicable regulatory code (e.g., IDE, ITA etc.).
Proactively, and with very little guidance, look for ways to facilitate strong performance and capabilities of study sites within their territory.
Independently trains all physicians and staff regarding protocol requirements (technical, medical and scientific) and the relevant study technologies.
Provides continuous communication of study progress with Marketing, Sales and Study teams.
Independently accountable for all aspects of study progress:
Identifies site-specific strategies to promote appropriate patient enrollment.
Identifies site successes and failures and assist in troubleshooting techniques that promote success.
Regularly provides feedback to the site on their progress.
Support local account team to help drive patient recruitment and technology adoption.
Protocol and Regulatory Compliance:
Identifies site-specific strategies to avoid deviations.
Identifies likely barriers to good compliance.
Provides tools to the site to facilitate good compliance.
Regularly provides feedback to the sites on their progress.
Provides expertise for the integration of new technology and features into the Canadian market (training and education of Abbott employees), where applicable to Clinical Studies.
Cultivates and nurtures strong collaborations with Investigators, and academic partners.
Review site visit reports; ensure tracking, follow up and resolution of site issues have been completed in a timely manner.
Independently looks for ways to prevent or correct issues at sites to enhance appropriate enrolments in Abbott clinical studies.
Maintains regular communication at investigational sites regarding planning and progress of studies and to best understand investigator’s interests and capabilities.
Provides outstanding clinical and technical expertise to proctor (if site not yet independent) or cover (if site independent) applicable procedures.
Trains all physicians and staff regarding protocol requirements (technical, medical and scientific) and the relevant study technologies.
Provides ethics committee submission details and contract negotiation details as required.
Provides comprehensive technical troubleshooting of equipment, devices, and clinical procedures for physicians and clinicians at study sites, including study follow-up visits.
Identifies and adapts to shifting priorities and competing demands.
Maintains relevant certifications (where appropriate).
Applies Standard Operating Procedures (SOP), Good Clinical Practice (GCP) and ISO standards as defined in Clinical Investigation of Medical Devices legislation including adverse event and safety reporting according to Abbott SOPs and as required by law.
Assists with the preparation of materials for Health Canada, FDA, and other audits and attends at site when necessary.
Applies latest developments in GCP and any applicable regulatory and/or legislative requirements in Canada and locally that could impact Abbott business.
Role models Abbott values and ensures personal contribution to clinical study activities.
Travel to visit investigational centers and to attend meetings as needed. This position may require approximately 60-70% travel within Canada.
Required Education and Experience:
University degree required
Good Clinical Practice (GCP) and ISO standards as defined in Clinical Investigation of Medical Devices legislation
Five to eight years’ clinical experience preferred
Possesses strong analytical and problem-solving skills
Computer competency in MS Office and other related programs
Knowledge and understanding of human physiology, relevant diagnostic and device technologies
Superior interpersonal skills
Attention to detail
Ability to work alone and with a team
Excellent communication and presentation skills
Superior organizational skills
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 email@example.com