Clinical Data Management Associate II - US - Remote- San Antonio, TX

Who we are We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence. We are Worldwide Clinical Trials, and we are a global team of over 3,500+ experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs – in the best possible way. Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit. Why Worldwide We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day. Join us! What the CDM Associate II does at Worldwide The Clinical Data Management Supervisor is responsible for eSource database design and development, electronic case report form (eCRF) design, and the monitoring, management, and archival of clinical data for all trials conducted at Worldwide Clinical Trials Early Phase Services Phase I Unit. The primary role is to troubleshoot for the clinic and other areas of the Clinical Pharmacology Unit (CPU), as well as to present ClinSpark to potential new clients. This role also serves as a liaison between the Data Management team and the Clinical Data Management team. A secondary responsibility is to assist other Clinical Data Management Associates in study building. This position has direct reports and reports to the Site Director. What you will do • Manage ClinSpark, an off-the-shelf electronic source system for Phase I clinical research • Design study databases to ensure accurate creation of eSource and eCRFs for data collection • Adhere to International Council for Harmonization - Good Clinical Practice (ICH-GCP) guidelines and Clinical Data Interchange Standards Consortium (CDISC) standards • Export clinical data listings and completed eCRFs to vendors as required • Assist with and perform database lock and unlock procedures • Review study protocols and supporting documents for each study • Attend study initiation visits and study planning meetings regularly • Develop eSource databases for capturing clinical data and manage required mid-study updates • Identify appropriate transfer fields for development of case report forms • Assist in tracking and driving departmental timelines and milestones • Prepare documents for final study report inclusion and assist in managing identified discrepancies • Create eCRF completion guidelines and access instructions for each study • Develop study-specific Data Management Plans as required • Create database specifications documents and perform verification/acceptance testing of configured databases • Perform medication and medical history coding as required • Review, examine, and perform manual and automated quality checks of data to identify discrepancies and resolve data integrity issues • Provide support and training for staff utilizing the eSource system • Provide support and training for monitors and sponsor representatives utilizing the eSource system • Manage archival of clinical trial documents, including paper and electronic records • Liaise with internal and external data management or biostatistics teams • Manage the data collection library • Participate in system upgrades and validation testing as required • Identify areas for process improvement and provide recommendations to management • Present ClinSpark capabilities to potential new clients in conjunction with staff during bid defense meetings and to support business development efforts • Maintain professionalism in behavior, appearance, and customer service when interacting with sponsors and internal staff as a representative of Worldwide Clinical Trials • Demonstrate strong collaboration with Worldwide Clinical Trials staff regarding data and compliance issues • Represent Worldwide Clinical Trials in a professional manner (verbal, written, and appearance) when interacting with sponsors, volunteers, vendors, and employees • Plan and manage daily workload to meet established study timelines • Coordinate with clinical staff to communicate priorities and maintain efficient workflow • Request, schedule, and complete required training for the position Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive. What you bring to the role • Strong ability to troubleshoot issues, identify errors, and assist or train others in processes and resolution • Self-motivated with the ability to manage multiple tasks and deadlines in a fast-paced environment • Strong sense of urgency and ability to balance priorities and meet deadlines • Strong computer skills, including database management knowledge • Excellent written and oral communication skills • Comfortable presenting to internal and external stakeholders • Exceptional attention to detail • Knowledge of the clinical research process, including Good Clinical Practice Your experience • Bachelor’s degree with at least three to five years of data management experience • Familiarity with medical terminology • Previous supervisory experience managing small or large teams • Prior customer-facing experience required • Preferred: One to three years of clinical research experience • Preferred: Three to five years of supervisory experience • Preferred: One to three years of general quality control experience • Data management certification and/or previous ClinSpark study design experience preferred Promotion to the next level is not automatic based on years of experience. Personnel are evaluated on proven competency, level of responsibility, and ability to work independently. At Worldwide Clinical Trials, we are committed to fostering an inclusive and equitable workplace by providing transparent compensation. The salary range for this position is annually (For hourly paid positions, the stated salary range reflects hourly rates): United States of America - $63,000.00 - $125,000.00 The salary range provided is intended to give candidates an understanding of potential earnings. Compensation will fall within the provided range, and it not a guarantee of exact salary. The final salary will be determined based on relevant experience, performance, education, and internal equity. In addition to base salary, we offer a competitive benefits package depending on location. We ensure pay equity and transparency and comply with all applicable labor laws. Salary information will be discussed during the interview process, and we encourage candidates to inquire about compensation at any stage. We love knowing that someone is going to have a better life because of the work we do. To view our other roles, check out our careers page at Discover a world of difference at Worldwide ! For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn .