Company : Abbott Laboratories
Country: United States
Location : Alameda, California
Post: Sun, 05 Nov 2023 09:59:01 GMT
Expires: Sun, 03 Dec 2023 23:59:59 GMT
Apply Job : Apply Online
—————————— Job Description ——————————
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.
Meet Lingo, a new biosensing technology that provides users a window into their body. Lingo tracks key biomarkers – such as glucose, ketones, and lactate – to help people make better decisions about their health and nutrition. Biowearable technology will digitize, decentralize and democratize healthcare, enabling consumers to take control of their own health
At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:
Career development with an international company where you can grow the career you dream of .
Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
An excellent retirement savings plan with high employer contribution
Tuition reimbursement, the student debt program and 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.
This Clinical Research Manager position will report into the Manager Medical Affairs at Lingo in. This position works out of Alameda, CA location.
As a Clinical Research Manager you will be responsible for the Study Plan including key milestones, timelines cost and resources, Monitoring, Communication, IP, Recruitment & Retention Plans while providing 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
WHAT YOU’LL DO
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.
Qualifications
Bachelor degree in science or a related field is required.
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.
Scientific or clinical experience in a discipline(s) involving inflammatory and/or metabolic processes.
Knowledge of regulations governing medical devices.
Preferred
Master’s or PhD degree in science or a related field
Experience with quality management system GAP analysis and audit preparation
Experience with CAPA
Strong clinical operations background
Previously work in roles that require understanding of digital consumer behavior
WHAT WE OFFER
At Abbott, you can have a good job that can grow into a great career. We offer:
A fast-paced work environment where your contribution is essential to success
Training and career development, with onboarding programs for new employees and tuition assistance
Financial security through competitive compensation, incentives and retirement plans
Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
Paid time off
401(k) retirement savings with a generous company match
The stability of a company with a record of strong financial performance and history of being actively involved in local communities
Learn more about our benefits that add real value to your life to help you live fully:
Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity.
Connect with us at , on Facebook at and on Twitter @AbbottNews and @AbbottGlobal.
The base pay for this position is $(phone number removed) – $(phone number removed). In specific locations, the pay range may vary from the range posted.