5 days old

Clinical Science Manager

Abbott
Alameda, CA 94501

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 103,000 colleagues serve people in more than 160 countries.

Responsible for the Study Plan including key milestones, timelines cost and resources, Monitoring, Communication, IP, Recruitment & Retention Plans.  Provide input to clinical regulatory documents (e.g. Investigator's Brochure (IB), Pre-IDE, IDE).  Responsible for the development of Protocol and related study documents with input from key stakeholders

Responsibilities:
 • Development of the Study Plan which includes key milestones, timelines cost and resources, Monitoring, Communication, IP, Recruitment & Retention Plans.  

• Provide input to clinical regulatory documents (e.g. Investigator's Brochure (IB), Pre-IDE, IDE).

• Author Protocol and related study documents with input from key stakeholders.

• Oversee and/or manage vendors (e.g. CROs, laboratories, etc.); may identify and select vendors as appropriate.

• Provide study status updates/progress reports to ensure key elements are clearly communicated to the appropriate cross-functional team members.

• Contribute to development and approval of study budget and contracts.

• Responsible for content development and delivery of internal and external study-related training.  

• Ensure effective study communications to internal and external stakeholders through meetings, presentations and other methods • Communicates regularly with extended study team including site status, issues, study timelines and ongoing data quality.

• Evaluate study-level issues and execute action plan to ensure resolution.

• Develop clinical strategy to support product development and market introduction.

• Coordinates the development of publications from clinical studies.

• Responsible for compliance with applicable Corporate and Divisional Policies.

Qualifications:

Bachelor’s degree in science or a related field is required. Master’s or PhD degree is preferred.  Minimum of 8 years of experience in Clinical research or relevant combination of clinical and laboratory experience is required. Experience in medical device related studies is desirable. Scientific or clinical experience in the field of diabetes is desired. Knowledge of regulations governing medical devices is desired.

Division: ADC Diabetes Care
Travel: Yes, 50 % of the Time
Medical Surveillance: Yes
Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

Categories

Posted: 2020-03-23 Expires: 2020-04-22

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Clinical Science Manager

Abbott
Alameda, CA 94501

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