Clinical Data Associate

Sitero is an emerging leader in Clinical services and software solutions for the life sciences industry. We have experience and expertise in a diverse range of therapeutic areas and focus on innovative, technology-enabled solutions that allow our clients to focus on their core strengths. For early phase studies through Phase III clinical trials, our experienced team delivers high-touch services and technology to ensure the safety of all stakeholders across the clinical research community with an emphasis on ethics, compliance, and innovation.

Job Title: Clinical Data Associate I (CDA I)

Location: Bengaluru /Mysuru
- Hybrid

Function: Clinical Data Management

ESSENTIAL DUTIES AND RESPONSIBILITIES

The Clinical Data Associate I is responsible for working with the Clinical Data Management team and other internal project team members to provide data management services for our customers to ensure on time and accurate deliverables. Responsibilities include providing data management guidance to internal project team members and customers; communicating with internal project team members and customers on all aspects of data management activities performed for a study; authoring data management documents; performing user acceptance testing on data management deliverables; and facilitating and verifying data clarifications and data changes.
- 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.
- 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.
- Having knowledge of Medidata Rave or any other EDC tool, and exposure to Business Object/JReview experience, which is an added advantage.
- Possessing knowledge of Clinical Protocol, data management plan, edit checks requirements, and data standards management.
- Producing project-specific status reports for management, PM, and/or clients on a regular basis and monitoring study metrics.
- Demonstrating strong verbal and written communication skills.
- Coordinating with the Medical Data Reviewer and/or Medical Monitor for the coding of medical terminology, as required.
- 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
- Preferably a life science graduate or equivalent qualification.
- 1-3 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 Sitero SOPs.
- Comprehension of study documentation standards including Trial Master File organization and archival processes.
- Cross functional collaboration & Stakeholder management.

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.

EMPLOYMENT TYPE

Full Time, Permanent

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.

DISCLAIMER

Sitero is an equal opportunity employer and welcomes all job applicants. All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.