Job Summary

Eccentric Clinical Research is seeking a talented and motivated Clinical Data manager to join the team in Gandhinagar, Gujarat. The successful candidate will be responsible for for leading internal and outsourced Data Management activities in support of our clinical trials. This includes managing Case Report Form (CRF) requirements, contributing to establishing defined company data standards, coordination of centralized data review activities, and is accountable for data integrity, quality, and consistency at database lock. The successful candidate will be a key interface with internal stakeholders and outside contract research organizations (CROs) for any data management-related activities. Knowledge of Industry and regulatory standards (CDISC, SDTM) with an ability to translate clinical team objectives into operational actions and maximizing the current technical platforms will be a heavily leveraged skill set.

About Us

We are a comprehensive Clinical Research Organization that offers a complete range of services to sponsors, covering every aspect from protocol development to the final submission of Clinical Study Reports (CSRs). The Eccentric Clinical Research is a trusted firm that specializes in providing clinical research services within India. Our extensive service portfolio includes clinical operations, site monitoring, data management, regulatory affairs, medical writing, and quality assurance. As experienced clinical research consultants, we assist our clients with proficient management of their clinical research projects and expert regulatory guidance. From project proposal evaluation to the successful completion of clinical trials, including necessary clearances and documentation, we provide continuous support and guidance to our clients at every stage of their projects.

Job Description:

· Provide leadership and content expertise for Clinical Data Management activities from start-up through statistical analysis stage of clinical studies to effectively manage data capture, review, and database lock activities.

· Participate in protocol review and ensure all protocol elements are accurately captured in the database

· Manage data activities for all clinical trials as well as the design, review, and validation of the clinical database

· Oversee or lead the design of electronic case report forms (eCRFs) as well as data management plans, data edit checks and aggregate check specifications with CROs, data transfer agreements and specifications, SDTM mapping, eCRF completion guidelines, Manual Review Guidelines, or Data Entry guidelines

· Oversee external data vendors with respect to key performance indicators, metrics, and program level deliverables and timelines.

· Oversee the development of any clinical database by the eDC/CRO vendor and manage the Sponsor user acceptance testing of the clinical database

· Review or perform external data reconciliation (i.e. laboratory data), and SAE reconciliation

· Proactively organize and perform on-going data review throughout the conduct of the study to ensure timely and appropriate identification of errors, trends, discrepancies, completeness, content, and quality issues

· Ensure proper closeout and archiving of data management study related materials, i.e. DMPs, database change documentation, validation documents, and final patient casebooks in paper or electronic format

· Proactively assess project and CDM issues and risks working with the Clinical Operations team

· Propose resolutions and mitigations to the Clinical Operations team and track issues and risks through to completion

· Define and monitor CDM related scope, cost, time and quality for all DM deliverables expected from CRO from project start up to close out

· Train sites at investigator meetings and data management staff on study database team

Qualifications & Required Skills:

5+ years of Clinical Data Management experience in biotech/pharma or CRO industry.

• EDC experience on multiple platforms.

• Excellent verbal, written, interpersonal and presentation skills are required

• Working knowledge and experience with Word, PowerPoint and Excel

• Working knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of routine clinical trials

• Must be able to prioritize multiple tasks, plan proactively, and accomplish goals using well-defined instructions and procedures

• Ability to develop tools and processes that increase measured efficiencies of the project

Job Types: Full-time, Permanent

Pay: From ₹800,000.00 per year

Benefits:

• Health insurance

Schedule:

• Day shift
• Monday to Friday

Supplemental pay types:

• Performance bonus

Education:

• Bachelor's (Preferred)

Experience:

• Data management: 5 years (Preferred)

Language:

• English (Preferred)

Work Location: In person

Expected Start Date: 22/04/2024