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Algorics

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3.6

based on 7 Reviews

17 Algorics Jobs

Clinical Data Associate/Senior Clinical Data Associate

Algorics

3.6

based on 7 Reviews

1-3 years

Bangalore / Bengaluru

1 vacancy

Clinical Data Associate/Senior Clinical Data Associate

Algorics

posted 1d ago

Job Role Insights

Key skills for the job

Data Entry Medical Coding Cron SAP CO Healthcare Clinical Research

+ 3 more

Job Description

Support the Lead DM as a back-up and/or team member, ensuring continuity, responsiveness,
and that tasks are performed in a timely manner
Perform data entry for paper-CRF studies, as needed
Perform quality control of data entry.
Provide input into timelines. Ensure that clinical data management deadlines are met with quality. May assess resource needs for assigned projects, as needed.
Assist in developing CRF specifications from the clinical study protocol and coordinate the
review/feedback from all stakeholders
Assist in building clinical databases.
Conduct database build UAT and maintain quality controlled database build documentation. May
oversee overall quality of the clinical database.
Assist in specifying requirements for all edit check types e.g., electronic, manual data review, edit checks, etc.
Responsible for creating, revising, appropriate versioning and maintaining data management documentation.
Train clinical research personnel on the study specific CRF, EDC, and other project related items
as needed.
Review and query clinical trial data according to the Data Management Plan
Perform line listing data review based on the guidance provided by the sponsor and/or Lead DM
Run patient and study level status and metric reporting.
Perform medical coding of medical terms relative to each other in order to ensure medical logic and consistency
Assist with coordinating SAE/AE reconciliation.
Assist with liaising with third-party vendors such as external data and EDC vendors in a project manager capacity in support of timelines and data-related deliverables
Assist with SAS programming and quality control of SAS programs used in the Data Management department.
Identify and troubleshoot operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholders.
Assist in reviewing and providing feedback on protocols, Statistical Analysis Plans (SAP) and
Clinical Study Reports (CSRs), if required by the project
Assist in participating in the development and maintenance of Standard Operating
Procedures (SOPs) and corresponding process documentation related to data management and
database management activities
Trains and ensures that all data management project team members have been sufficiently trained.
Communicate with study sponsors, vendors and project teams as needed regarding data, database or other relevant project issues.
Present software demonstrations/trainings, department/company training sessions, present at project meetings
Perform other duties as assigned.

Qualifications

Minimum Required:

4+ years experience within Data Management
Bachelors within scientific/science background and combination of related experience

Other Required:

Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook.
Able to handle a variety of data management task and oversight.
Excellent organizational and communication skills
Professional use of the English language; both written and oral.
Basic knowledge of drug, device and/or biologic development and effective data management
practices

Preferred:

Experience in a clinical, scientific or healthcare discipline.
Dictionary medical coding (MedDRA and WHODrug)
Understanding of CDISC standards (CDASH, SDTM, ADaM, etc.)
Oncology and/or Orphan Drug therapeutic experience

Skills:

Demonstrates strong knowledge of ICH-GCP, relevant Precision Oncology SOPs, and regulatory guidance, as well as the ability to implement and drive outcomes

Competencies:

Motivates project team members to meet timelines and project goals
Focuses on continuous improvement, including the ability to make proactive assessments on how to make processes more efficient and people more effective
Resolves project related problems and prioritizes workload to meet deadlines with minimal support
Exhibits a high degree of self-motivation, and can work and plan independently as well as in a team environment
Demonstrates an acceptable degree of professionalism, as evidenced by punctuality, ability to deliver on commitments, an understanding of the service culture and positive interactions with customers and teammates, including good interpersonal skills

Employment Type: Full Time, Permanent

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