Associate Clinical Data Manager

RXinsider LTD.; Maple Grove (MN); Hybrid; USD 61,000 - 123,000; Full time

Benefits offered by this job

Health insurance

Retirement plan

Tuition reimbursement

Job summary

Abbott in Maple Grove, MN is seeking an Associate Clinical Data Manager to execute data management activities across the life cycle of clinical studies. You will translate study requirements into data capture specifications and collaborate with the data review team to ensure data quality and compliance.

The role requires 3+ years in a clinical or research setting, experience with EDC and data management practices, and a CCD M or equivalent certification is preferred.

Qualifications

• Bachelor’s degree in a related field or equivalent experience.
• 3 years in a clinical, medical or research environment.
• Experience with clinical data management, data capture, and data management best practices.
• Knowledge of FDA regulations and Good Clinical Data Management Practices.
• CCD M or equivalent certification preferred.

Responsibilities

• Develop CRFs and edit checks with cross-functional input.
• Define data listings specifications for ongoing data review.
• Coordinate data transfer specs for external data imports.
• Create and test edit checks to detect illogical or missing data.
• Collaborate with study teams to resolve data issues.
• Support Clinical Database systems and data management validation activities.
• Perform UAT on study databases, reports, and notifications.
• Use SQL and database tools to identify data issues and drive resolutions.
• Attend Clinical Study Team meetings.
• Assist in audits and regulatory inspections related to data management.
• Contribute to data cleaning and data snapshot efforts for regulatory submissions.

Skills

Data management

SQL

EDC experience

Documentation

Analytical thinking

Communication skills

Education

Bachelor's degree or equivalent

CCDM certification or equivalent

Tools

EDC databases

Excel

SQL tools

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.

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.
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• 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.

For years, Abbott’s medical device businesses have offered technologies that are faster, more effective, and less invasive. Whether it’s glucose monitoring system, innovative therapies for treating heart disease, or products that help people with chronic pain or movement disorders, our medical device technologies are designed to help people live their lives better and healthier. Every day, our technologies help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine finger sticks.

The Opportunity

Our location in Maple Grove MN currently has an on‑site opportunity for an Associate Clinical Data Manager. The Associate Clinical Data Manager is responsible for performing data management tasks within defined established processes throughout the life cycle of the study including startup, conduct and reporting phases.

What You’ll Work On

Works with Data Review Manager in the study start‑up and planning, including contributing to the development of the Risk Assessment and Risk Mitigation Plan, Data Management Plan, Central Monitoring Plan and Data Review Plan.

Translates Clinical Study requirements into technical requirements for eCRFs, edit checks, study notifications and customizations in the study database in close collaboration with other members of the data review team.

• Able to develop CRF with cross functional support, incorporating appropriate feedback and finalizing the CRF.
• Able to develop specifications for data listings for continuous data review, and communicate with data analytics team members through their development and release.
• Able to work with external non‑CRF data, including developing creating Data Transfer Specifications, verification of external data structure for import into the data model.
• Able to develop edit check specifications to review for illogical, incomplete and inconsistent data including testing and troubleshooting of edit checks.
• Identifies, analyzes, proposes solutions, and effectively resolves complex data/database structure issues by exercising appropriate judgment and collaborating with the clinical project team members and other shared service functions.
• Contributes to the development and maintenance of Clinical Database systems, including EDC, Edit Checks, Reporting, Study Notifications, etc. through the following :
• Partner closely with Data Review Management, Study Database Manager, and Data Analytics and Systems and other Data Review team members.
• Perform and document functional and/or user acceptance testing on study databases, reports, study notifications, and database customizations.
• Utilize existing tools/reports, SQL, and database UI to identify data issues and drive resolutions with the Clinical Study Team in a timely manner.
• Attend Clinical Study Team meetings.
• Contribute technical expertise to cross functional teams through CRF changes and the impact on databases and propose implementation strategies.
• Assists in FDA and Quality System audits that involve Clinical Database and Data Management

Follows data management standards and best practices and assures Standard processes are followed for Data Management activities.

Contribute to data cleaning and data snapshot efforts for regulatory submissions and other business needs as requested by the Clinical Study Team through the following :

• Generate database snapshot and prepare datasets for Biometrics.
• Contribute to data review meetings with the Clinical Study Team and Biometrics to identify data cleaning issues and strategize cleaning efforts.
• Monitor overall data management tasks to ensure that timelines are met and that any issues are proactively identified and resolved.

Perform other duties as assigned.

Required Qualifications

• Bachelor’s degree in a related field OR an equivalent combination of education and work experience.
• Minimum 3 years’ in clinical, medical or research setting.
• Education and work experience in computer science, life sciences or technical field.
• Knowledge of data collection best practices for clinical trials.
• Knowledge of global clinical operations.
• Intermediate therapy specific knowledge of anatomy, physiology, pathophysiology, therapy and device.
• Intermediate medical knowledge related to common medical histories, medical terminology, diagnostics (imaging, laboratory), and medications (class, dose, route).
• Certified Clinical Data Manager (CCDM) or equivalent.

PreferredQualifications

• Bachelor’s degree in business administration, data science, statistics or life sciences.
• 3 years’ experience in clinical operations or healthcare related field.
• Knowledge of data management practices from CRF design to database development and study closure.
• Experience with using Electronic Data Capture (EDC) databases and advanced skill level working in Excel.
• Knowledge of documentation practices in-line with Good Clinical Data Management Practices, and other FDA regulations and guidelines is required.
• Ability to leverage and/or engage others to accomplish projects.
• Solid oral and written communications skills and analytical/problem-solving skills.
• Must be able to effectively manage multiple projects and timelines.
• Requires the ability to sit or stand while working on a computer for a long period of time.

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.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 $61,300.00 – $122,700.00. In specific locations, the pay range may vary from the range posted.