Clinical Data Management Associate I

Requisition Number: 1408

Position Title: Clinical Data Management Associate I

External Description:

SUMMARY:  The Clinical Data Management Associate I, under the guidance and supervision of the Manager, Clinical Data Department, is responsible for monitoring, management, and processing of clinical data to ensure the quality and integrity of the overall conduct of clinical trials.
 
Tasks may include but are not limited to:

• Builds and develops the study database to ensure accurate creation of eSource and case report forms for data collection.
• Export clinical data listings and completed eCRF to vendors as required.
• The review study protocol and supporting documents for each study.
• Monitor data collection in real-time and post-collection for quality and completeness.
• Review, examine, and perform manual and automated quality checks of data to identify discrepancies and resolve data integrity issues.
• Assist and Perform database lock and or unlock procedures.
• Provide support and training for staff utilizing the database.
• Manages the archival of clinical trial documents (paper and electronic records) and complete requests for the on-site and off-site archive.
• Prepares documents for the final study report inclusion and assists in managing any identified discrepancies.
• Develops an understanding of ICH-GCP Guidelines.
• Responsible for requesting, scheduling, and completing any training required for this position.
• Identifies areas for process improvement and provides information to management.
• Performs additional assignments as warranted by upcoming and ongoing clinical research studies.
•  The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.

 OTHER SKILLS AND ABILITIES:

• Excellent written and oral communication skills. 
• Ability to understand complex written and oral instructions. 
• Computer systems and applications knowledge
• Strong interpersonal skills. 
• Excellent attention to detail. 
• Exceptional organizational skills. 
• Ability to set and meet multiple deadlines
• Knowledge of the clinical research process, including Good Clinical Practice
• Possible equipment includes, but is not limited to: computers, rolling carts, fax machines, photocopiers, telephone, mop/broom, scales, calculators, vital signs equipment, ECG equipment, and other medical equipment.

REQUIREMENTS:
Required: Bachelor’s degree with at least 2 years of clinical research or quality control experience.
 
Preferred: Bachelor’s degree (preferably in the field of Health); at least 3 years of clinical research experience and/or experience with Regulatory documents and/or Quality

City:

State: Texas

Employment Type: Regular

Community / Marketing Title: Clinical Data Management Associate I

Company Profile:

We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.

Location_formattedLocationLong: San Antonio, Texas US

CountryEEOText_Description: Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law. Worldwide is committed to working with and providing reasonable accommodations to applicants with disabilities. We are proud to be an equal opportunity workplace where people thrive by being themselves and are inspired to do their best work every day.