07 Aug
|
Siro Clinpharm
|
Hyderabad
07 Aug
Siro Clinpharm
Hyderabad
Job Title: Data Coordinator, Clinical Data Management
Location - PAN INDIA
Experience - 5+ years
Key Accountabilities
Under the direction of the CDM Lead or delegate, performs data management tasks according to applicable SOPs (Standard Operating Procedures) and processes. These activities may include the following categories:
Data Review
Performs data review of clinical trial data, including query management.
Performs reconciliation review of external data against EDC data.
May assist in creating study documents or assist in running study reports and metrics.
Performs additional review activities for interim and final database locks as needed.
Documentation & Filing
Files study documentation in electronic Trial Master File (eTMF) and department project files.
Performs periodic quality review of eTMF documents.
Assists with taking meeting minutes and documenting/tracking study data management activities.
Performs data archival activities.
Performs inspection readiness activities and supports the CDM team during internal and regulatory inspections.
Data Collection Systems
May support the set-up and testing of study data collection tools.
Additional Activities
Assists with quality review of the above activities performed by the CRO, as needed.
Ensures compliance with own Learning Curricula, corporate and/or GxP requirements.
Performs other duties as assigned.
Special Skills/Abilities
Strong attention to detail and organizational skills.
Valuable time management skills.
Quick learner and comfortable learning new technologies and systems.
Positive knowledge of Microsoft Office.
Behavioral Competencies
Comfortable working in an ambiguous setting.
Excellent teamwork, organizational, interpersonal, conflict resolution, and problem-solving skills.
📌 Clinical Data Coordinator Hyderabad
🏢 Siro Clinpharm
📍 Hyderabad