Clinical Data Management Supervisor
Location: San Antonio, Texas, United States
Requisition Number: 3213
Position Title: Clinical Data Management Supervisor
SUMMARY: The Clinical Data Management Associate Supervisor, is responsible for eSource database design and development, electronic case report form design and the monitoring, management and archival of clinical data for all trials conducted at Worldwide Clinical Trials Early Phase Services Phase I Unit. Primary role is to trouble shoot for clinic and other areas of CPU as well as to present ClinSpark to potential new clients of the CPU. This role will also be a liason between our Data Management team and our Clinical Data Management Team. Secondary role is to assist other Clinical Data Management Associates in study building. This position has direct reports and will report to the Site Director.
Tasks may include but are not limited to:
- Manages ClinSpark, an off the shelf, electronic source for Phase 1 Clinical Research.
- Design study databases to ensure accurate creation of eSource and case report forms for data collection.
- Adheres to ICH-GCP Guidelines and C-DISC standards.
- Export clinical data listings and completed eCRF to vendors as required
- Assists and performs database lock or unlock procedures.
- Reviews study protocol and supporting documents for each study.
- Regularly attend study initiation visits and study planning meetings.
- Develops eSource database for capture of clinical data and manage required mid study updates.
- Identify appropriate transfer fields for development of Case Report Form.
- Assists in the tracking of and drive departmental timelines and milestones.
- Prepared documents for final study report inclusion and assists in managing any identified discrepancies.
- Create eCRF completion guidelines and access instructions per study.
- Create study specific Data Management Plan as required.
- Create Database Specifications document.
- Perform verification/acceptance testing of configured databases.
- Perform medication/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 monitor and Sponsor representatives utilizing the eSource system.
- Manage archival of clinical trial documents (paper and electronic records).
- Prepares documents for final study report inclusion and assists in managing any identified discrepancies.
- Liaise with both internal and external data management or biostatics teams.
- Manages data collection library.
- Participate in system upgrades and validation testing as required.
- Identifies areas for process improvement and provides information to management.
This role will present ClinSpark capabilities to potential new clients in conjunction with other staff during Bid Defense meetings and or to support winning potential work.
- The Clinical Data Management Associate III will have contact with Sponsors and internal staff. Professionalism in behavior and appearance and customer service will be of the utmost importance as a representative of Worldwide. The Clinical Data Management Associate III must acquire and use exemplary skills in working with Worldwide staff regarding data and compliance issues.
- Always represents Worldwide in a professional manner (verbal, written and in appearance) when interacting with Sponsors, volunteers, outside vendors and fellow employees.
- The Clinical Data Management Associate III, is responsible for planning and managing his/her daily workload with the goal of meeting set study timelines. He/she must be must be able to coordinate with other clinical staff to communicate priorities and maintain an efficient workflow.
- Responsible for requesting, scheduling and completing any training required for this 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.
OTHER SKILLS AND ABILITIES:
- Strong ability to troubleshoot issues, identify errors, and assist/train others on process and resolution.
- Self-motivated and able to manage multiple tasks and deadlines in a fast-paced environment to ensure that all timelines are met.
- Strong sense of urgency and the ability to balance priorities and meet deadlines.
- Strong computer skills, including knowledge of database management.
- Excellent Written and oral communication skills. Should be comfortable presenting to internal and external clients.
- Exceptional attention to detail.
- Knowledge of clinical research process, including Good Clinical Practice.
- Bachelor’s degree
- 1-3 years of Data Management experience
- Must be familiar with medical terminology.
- 1-3 years of clinical research background.
- 1-3 years of general quality control experience.
Employment Type: Regular
Community / Marketing Title: Clinical Data Management Supervisor
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 Clinical Trials is an equal opportunity employer, dedicated to a policy of non-discrimination in employment on any basis including age, sex, color, race, creed, national origin, religion, marital status, sexual orientation, political belief or disability.