Medical Data Reviewer

2 weeks ago

Bengaluru Karnataka, India Stafford Information Technology Pvt. Ltd. Asconis Full time

**Key Responsibilities**:

- Conduct **Risk-Based Monitoring (RBM)** and Centralized Monitoring to identify data trends and potential risks early, addressing them proactively with relevant study teams.
- Support **SAE reconciliation, coding review, lab data analysis**, and ensure regulatory compliance across trials.
- Utilize tools such as **TIBCO Spotfire for data visualization and reporting**, Medidata Rave, and Oracle Clinical for effective data tracking and resolution.
- Collaborate with **Data Management, Clinical Operations, Biostatistics, and Pharmacovigilance teams** to ensure integrated data review processes.
- Contribute to database lock and close-out activities by validating data accuracy and completeness.
- Document and maintain detailed records, prepare Medical Data Review Plans (MDRPs), and provide insights to optimize data quality procedures.

**Qualifications**:

- Advanced degree in **Medicine (MBBS/MD), Dentistry (BDS/MDS), Life Sciences (BSc/MSc)**, or a related field.
- **5-9 years** of experience in Medical Data Review, ideally in **Risk-Based Monitoring and Centralized Monitoring settings**.
- Proficient in **CDMS, MedDRA, WHO-DD, and EDC platforms** (Medidata Rave, Oracle Clinical) and **data reporting/visualization tools like TIBCO Spotfire**.
- Solid understanding of **oncology therapeutic areas** (e.g., Non-Small Cell Lung Cancer, Small Cell Lung Cancer, Malignant Melanoma).
- Familiarity with **Pharmacovigilance principles** and strong attention to **safety and efficacy data review**.
- Excellent Web researching skills, Good Knowledge of MS-Office (Excel, Word, PowerPoint, etc.) and excellent written and verbal communication skills.

**Preferred Skills**:

- Experience with **oncology clinical trials** and medical coding standards.
- Strong analytical and problem-solving abilities with excellent attention to detail.
- Effective cross-functional communication and **collaborative mindset**.
- Good working knowledge of US and EU drug safety regulations, CIOMS and ICH guidelines.

**Other Skills**:

- Strong commitment to **data quality and compliance** with regulatory requirements.
- Ability to manage multiple projects with a proactive, solutions-oriented approach.

This position offers a unique opportunity to make a meaningful impact within a leading clinical research organization in Bangalore. If you have experience in medical data review with a focus on oncology and data management systems, we encourage you to apply.

**Job Types**: Full-time, Permanent

Pay: From ₹90,000.00 per month

**Benefits**:

- Health insurance

Schedule:

- Monday to Friday
- US shift

Supplemental Pay:

- Yearly bonus

**Experience**:

- total work: 1 year (preferred)

Work Location: In person

Expected Start Date: 15/11/2024

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