Sr. Clinical Data Associate

ESSENTIAL DUTIES AND RESPONSIBILITIES 

You would be responsible for: 

·       Participating in the preparation/review of Data Management process control documents, including but not limited to the Data Management Plan, Data Validation Specification, User Acceptance Testing, Data Transfer Agreements/Specifications, External Reconciliation plans, SAE Reconciliation, CRF Completion Guidelines, etc. 

·       May serve as the Lead Data Manager (client-facing role) on assigned projects. 

·       Attending regular meetings with the Sponsor and project team for discussions relating to data management issues and providing status updates for the project with guidance from the Project Data Manager/Project Manager. 

·       Effectively managing all data management aspects of assigned project(s) from set up to database lock. 

·       Participating in in-house and external training courses, as required. 

·       Demonstrating strong project management skills, client management skills, and a focus on customer needs. 

·       Acting as a liaison to the leadership and client on all Data Management activities for the study. 

·       Supervising the Data Management team. 

·       Having knowledge of Medidata Rave or any other EDC tool, and exposure to Business Object/JReview experience, which is an added advantage. 

·       Having the ability to set and meet timelines or recognize and schedule changes in response to project demands. 

·       Having the ability to train, mentor, and direct the study team and perform ongoing quality control and data review. 

·       Possessing knowledge of Clinical Protocol, data management plan, edit checks requirements, and data standards management. 

·       Having TA-specific knowledge, SOP management, creation, and accountability of the process. 

·       Producing project-specific status reports for management, PM, and/or clients on a regular basis and monitoring study metrics. 

·       Coordinating and managing training and EDC access for investigators, coordinators, data entry, and CRAs on selected applications for data entry, cleaning, and running reports, as applicable to study parameters. 

·       Demonstrating strong verbal and written communication skills. 

·       Participating in eTMF audits as necessary and responding to auditors' comments in a timely fashion. 

·       Coordinating with the Medical Data Reviewer and/or Medical Monitor for the coding of medical terminology, as required. 

·       Having a solid understanding and implementation of CDISC standards. 

·       Demonstrating initiative and motivation. 

·       Being capable of directing and promoting teamwork in a multi-disciplinary team setting. 

·       Possessing excellent written and verbal communication skills. 

·       Having a strong knowledge of ICH guidelines. 

EDUCATION AND EXPERIENCE REQUIRED 

·       Minimum Educational Requirement: Preferably a life science graduate or equivalent qualification. 

·       8-10 years of clinical data management experience within Contract Research Organizations (CRO), Pharmaceutical, or biotech industries. 

·       Effective working knowledge of Microsoft Office Suite, including Word and Excel. 

·       Demonstrated proactiveness, problem-solving, analytical, organizational, and time management skills. 

·       Demonstrated flexibility and ability to work well in a fast-paced, growing organization. 

·       Demonstrated ability to work in a global team environment. 

·       Demonstrates a basic understanding of Clinical Trials and the flow of data. 

·   Demonstrated ability to comply with ICH-GCP/ regional regulatory guidelines and POI SOPs. 

·    Comprehension of study documentation standards including Trial Master File organization and archival processes. 

·     Familiarization of data standards, preferably CDISC STDM. 

·     Cross functional collaboration & Stakeholder management 

·    Coach/mentor new team members to support efficient and quick on-boarding.