Senior Clinical Data Associate

Location

Bangalore | India

Job description

• 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.

COMPENSATION BENEFITS

• Sitero proudly offers an impressive compensation package and benefits, including a competitive salary, Variable pay, paid time off, and healthcare and retirement benefits.

COMMITMENTS

• Standard Hours 40 hours per week, one hour lunch, Monday - Friday. Additional hours as needed.
• Willing to work in shifts as and when needed.

Job tags

Salary