SUMMARY: The Clinical Data Management Associate, under the guidance and supervision of the Manager, Clinical Data Department, 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.
Tasks may include but are not limited to:
- Always represents Worldwide in a professional manner (verbal, written and in appearance) when interacting with Sponsors, volunteers, outside vendors and fellow employees.
- Review study protocol and supporting documents for each study.
- Regularly attend study initiation visits and study planning meetings.
- Develop 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.
- 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.
- Monitor data collection for quality and completeness.
- Review, examine, and perform manual and automated quality checks of data to identify discrepancies and resolve data integrity issues.
- Perform database lock and unlock procedures.
- Export clinical data listings and completed eCRF to vendors as required.
- 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) and complete requests for on-site and off-site archive.
- 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.
- Develops understanding of ICH-GCP Guidelines and C-DISC standards.
- 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.
- Performs 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:
- 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.
- Ability to phrase queries in an understandable and impartial manner.
REQUIREMENTS:
Required: Bachelor’s degree with at least 3 years of clinical research experience.
Other: Possible mental demands include, but are not limited to: reading, math, intense concentration, verbal communication, written communication, and client contact, exceptional attention to detail, multi- tasks, frequent interruptions, and fluctuation in work load.
The Clinical Data Management Associate, 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 must acquire and use exemplary skills in working with Worldwide staff regarding data and compliance issues.
Possible physical demands include, but are not limited to: Extended periods of time at a computer; lifting and carrying of objects weighing 5-50 pounds; hearing; seeing; gross and fine motor use of upper extremities; kneeling; walking; standing; leaning over for extended periods; squatting; eye strain/fatigue; climbing; pushing; pulling; reaching; exposure risk to potentially infectious blood and/or body fluids, and/or hazardous fumes or chemicals.
The Clinical Data Management Associate, is responsible for planning and managing his/her daily workload with the goal of meeting set study timelines. He/she must be self-motivated and able to manage multiple tasks and deadlines to ensure that all timelines are met. Must be able to coordinate with other clinical staff to communicate priorities and maintain an efficient workflow. Must be able to follow written and verbal communication.