Clinical Database Programmer

Skill Required:

• Clinical Data Services - Clinical Reports Management

Designation:

Clinical Data Svs Specialist

Qualifications:

• BE/BTech/MCA

Years of Experience:

• 7 to 11 years

Job Overview:

You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world's leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.

Clinical Data Management Team Responsibilities:

• Collection, integration, and availability of data at appropriate quality and cost.
• Performing data management activities including discrepancy review, query generation, and resolution.
• Creating CRF Completion Guidelines (CCG) and SAE reconciliation guidelines.
• Identifying and raising protocol deviations in the database.
• Performing edit check validation by creating test cases, writing test scripts, and carrying out database validation (UAT) against the specified CRF/ECRF.
• Managing clinical data management projects.

Role Specific Responsibilities:

• Develop clinical trial reports using SAS, J-review, Cognos, SQL, and PLSQL as per study requirements.

Skills and Competencies:

• SAS Clinical
• Oracle Procedural Language Extensions to SQL (PLSQL)
• Python (Programming Language)
• R Programming
• Clinical Database Programming
• Adaptable and flexible
• Ability to perform under pressure
• Problem-solving skills
• Agility for quick learning
• Ability to establish strong client relationships

Roles and Responsibilities:

• Analyze and solve moderately complex problems.
• Create new solutions, leveraging and adapting existing methods and procedures as needed.
• Understand the strategic direction set by senior management as it relates to team goals.
• Primary upward interaction with direct supervisor.
• May interact with peers and/or management levels at a client and/or within the organization.
• Receive guidance when determining methods and procedures on new assignments.
• Decisions made will often impact the team.
• Manage small teams and/or work efforts (if in an individual contributor role) at a client or within the organization.
• This role may require you to work in rotational shifts.

Education

• BE
• BTech
• MCA