Clinical Program Analyst

Abbott Laboratories hiring for Clinical Program Analyst jobs in Alameda, CA, US

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 114,000 colleagues serve people in more than 160 countries.

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.

Working at Abbott

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 Freedom 2 Save student debt program and FreeU 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.

At Abbott, we believe people with diabetes should have the freedom to enjoy active lives. That’s why we’re focused on helping people with diabetes manage their health more effectively and comfortably, with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology.

The Opportunity

This position is responsible for implementation and management of project management activities within Systems/IT mainly (data management secondly). Incumbent will be supporting Senior Manager to achieve metrics related to activities in support of clinical trials, including design and maintenance of clinical databases using OpenClinica EDC, Veeva ETMF, decentralization tools, SAS; review of data collection forms; generation of data tables, listings and reports; establishment and documentation of data management processes.  This candidate will be exposed to designing, programming, installing, and maintaining quality databases for the clinical studies. They will also provide technical support for assigned databases responding to database and user problems, determines causes and resolutions of problems when they arise to ensure continued operations. to analyze the data. The candidate should be very flexible and strong in assisting leadership to document and structure the management of complex and often changing environments.

What you’ll work on

• Project Management toolkit

• Ensure that database design is consistent with 21 CFR part 11.

• Provide input to the development of case report forms, in conjunction with Clinical Research and Clinical Data Specialists.

• Annotate CRFs and develop study clinical databases using Oracle Clinical or other clinical database.

• In conjunction with Clinical Data Specialists, write study specific data entry work instructions.

• In conjunction with the Validation team, ensure databases are validated and data entry training has been provided before the database is activated.

• With Clinical Research staff and Clinical Data Specialists, contribute to the development of data edit check rules.

• Program edit checks and provide documentation of data validation checks.

• Contribute to Data Management Plan to document study specific data management activities that will ensure data integrity.

• Participate in efforts to standardize, streamline and enhance DM processes, write SOPs.

• Generate data tables, listings, reports, and ad hoc queries from Oracle Clinical and related databases using SAS or other software tools.

• Maintain clinical databases according to change control procedures.

• Oversee query generation and resolution and resolve issues with validation rules.

• Provide programming support to the CRAs as needed.

• Act as a resource for database related questions.

• Prepare and review reports clearly communicating results in a manner suitable for both technical and nontechnical customers.

• Support software requirements including development, maintenance and validation of software for Clinical Affairs Group as required.

• Provide general (statistical) software support to the Clinical Affairs Group and other departments as required.

• Collaborate with companywide groups as and when required.

• Provide supervision to staff, including setting direction and goals, performance reviews and development plans as and when required.

• Must be able to tap into appropriate resources when specific expertise is needed that cannot be achieved individually.

• Support relevant training activities, presenting data and results in a suitable format.

Required Qualifications

• Bachelors’ degree required.  Management, Psychology, Information science, public health, or life science preferred.  

• Minimum of 3 years’ experience in clinical research and database programming; prefer at least 1 year in device or pharmaceutical clinical trials as a clinical programmer performing mentioned above functions using SAS, Oracle Clinical or Clintrial and/or ACCESS

• If applicant has strong project management background other requirements may possibly be waived.

Preferred Qualifications

• PMP is a big plus.

• Experience building at least one major clinical database  Coordinates and monitors activities/projects  Able to set up, clearly communicate and follow project plans 

• Participated in SOP, WI and other guidelines design 

• Provides technical support to all the members of the team

• Shares resources, knowledge, and accountability, leads others 

• Must have experience in using SAS, word processor applications, spreadsheets, and databases. 

• Must be accurate and organized in work approach and have good attention to detail. 

•  Must have good oral communication skills to be able to present to staff and report and present progress to Senior Management. 

• Must have good written communication skills to be able to prepare appropriate reports and prepare effective summaries.

Apply Now

* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:  www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

The base pay for this position is $83,600.00 – $167,200.00. In specific locations, the pay range may vary from the range posted.