HiringSr. Clinical Data Associate - Immediate AvailabilitySitero

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• Sitero
• Sr. Clinical Data Associate - Immediate Availability

Sr. Clinical Data Associate - Immediate Availability
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Engineering · Full-time · Bengaluru, India

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Job description
IMMEDIATE JOINERS REQUIRED
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.

· 5-10 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.

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