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Clinical Data Associate II - 2306148649W

Description

Abiomed is recruiting for a Clinical Data Associate II. This is a field-based role.

The Clinical Data Associate II (CDA II) will support data management activities for Abiomed sponsored studies throughout the lifecycle of the clinical study including start-up, maintenance and completion activities. The CDA facilitates information sharing across the various functional study team members to facilitate high quality and timely study execution. She/he will assist with data management activities including development of Case Report Forms (CRFs) and associated CRF Completion Guidelines, conducting User Acceptance Testing (UAT) to ensure the clinical study database adheres to functional requirements, status reporting and metric gathering, conducting data review and associated query generation/resolution, reconciliation of Core Lab and external data sources, and maintenance of all data management quality record archiving. The CDA II may need to engage and work closely with CROs and Vendors that execute the data management and Core Lab services.

Key Responsibilities:

• Performs data management activities and facilitates task completion within the data management team.

• Reviews data and manages queries based on programmed edit checks and Data Management Plan.

• Work independently to provide data review listings as requested by clinical and medical teams.

• Reviews data listings to clean data and issue queries if needed.

• Contributes to preparation and maintenance of DM documents.

• Works with clinical programming team/vendor to develop eCRF and associated Completion Guidelines.

• Performs EDC User Acceptance Testing (UAT).

• Supports and provides cross-functional collaboration and communications to increase quality of data management deliverables.

• Performs external vendor (i.e., Core Labs) data processing and external vendor data reconciliation.

• Provides data review metrics, query metrics and other metrics on a scheduled and ad hoc basis as requested.

• Examines data to identify trends/anomalies beyond scope of initial review.

• Ability to perform additional responsibilities as requested.

Qualifications

Required:

• Minimum of two years experience in CRO, pharmaceutical, biotechnology, or medical device industry.

• Experience with Electronic Data Capture (EDC) technology and process required. Medidata Rave experience preferred.

• Experience with JReview and/or reporting tools required.

• Knowledge of GCP and regulatory compliance guidelines for clinical trials required.

• Bachelor’s degree from an accredited university required; BS preferred in Life Sciences, Nursing, Computer Sciences, Data Science/Analytics, Mathematics, or related medical/scientific field. An equivalent combination of education, experience and performance may be considered.

• Ability to travel 5%.

Preferred:

• Experience with Veeva Vault electronic Trial Master File (eTMF) desired.

• Must be computer savvy and highly proficient in Microsoft Office.

• Able to acquire and apply new technical skills.

• High attention to details and accuracy; ability to work independently and to prioritize and organize work to meet deadlines.

• Excellent interpersonal communication skills; Works effectively on cross-functional teams.

The anticipated base pay range for this position is $70,000 to $112,700.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.

Primary Location NA-United States

Organization ABIOMED Inc.(6942)

Job Function Clinical Data Management

Req ID: 2306148649W