Clinical Data Manager II

Posted 16 Hours Ago
Be an Early Applicant
Hyderabad, Telangana, IND
In-Office
Senior level
Healthtech • Biotech
The Role
Manage end-to-end clinical study data: design eCRFs/databases, create Data Management Plans, develop edits/derivations, integrate and extract data, produce reports/metrics, coordinate with sponsors and study teams, and ensure data quality and regulatory compliance.
Summary Generated by Built In

We’re on a mission to change the future of
clinical research. At Perceptive, we help the
biopharmaceutical industry bring medical
treatments to the market, faster.
Our mission is to change the world
but to do this, we need people like you.

Apart from job satisfaction, we can offer you:

HEALTH:

- Medical plan for you and your dependents.

- Personal Accident Insurance

- Life Insurance

- Critical illness cover

WEALTH:

- Salary structure and Flexi basket

- Provident fund of 12%

- Gratuity scheme

YOURSELF: Internal growth and development programs & trainings

The Clinical Data Manager II is an end-to-end data custodian and plays a key role in managing data and ensuring its accuracy, completeness, and compliance with regulatory standards while providing data management support to study teams. The Clinical Data Manager excels in defining overall data standards, data collection requirements, data import, extraction, reporting, and analysis methods. The incumbent shall demonstrate a strong working knowledge of Good Clinical Data Management Practices.

Key Responsibilities:

Primary

The Clinical Data Manager II plays an essential role in the efficient design of project databases, the integration of data from multiple sources, and the reporting and analysis of key study data metrics.  The incumbent will recommend and drive solutions for database design and data reporting.  This role is critical for meeting sponsor study data endpoints and requirements.

  • Design study CRFs and databases utilizing eCRF library

  • Create study Data Management Plan and deployment roadmap

  • Monitor study timelines and communicate risk

  • Develop database edits, rules, and derivations

  • Prepare tracking reports and metrics

  • Facilitate study team involvement in database development

  • Prepare data extracts and processing for sponsor deliverables

  • Communicate with sponsors regarding study data processes, endpoints, and overall data management process

Other

  • Carryout any other reasonable duties as requested.

Functional Competencies (Technical knowledge/Skills)

  • Technical project management and oversight

  • Task creation and tracking via ticketing software

  • Proficient with clinical data management systems

  • Experience working with research support or clinical team

Experience, Education, and Certifications

  • Bachelor’s Degree in Life Science (Biology, Medical Technology, Research Psychology, Math or Health Science or equivalent experience in a related field

  • 5-7 years practical work experience in a clinical or technical setting

  • Demonstrated experience in team settings to achieve goals

  • Demonstrated experience with clinical data management systems

  • Experience working with research support or clinical team

  • English: Fluent

Come as you are.

We're proud to be a Equal Employment Opportunity employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.

Skills Required

  • Bachelor's degree in Life Science or equivalent
  • 5-7 years practical work experience in a clinical or technical setting
  • Demonstrated experience with clinical data management systems
  • Experience working with research support or clinical teams
  • Fluent English
  • Technical project management and oversight experience
  • Experience creating and tracking tasks via ticketing software
  • Experience designing study CRFs and databases (eCRF library)
  • Experience developing database edits, rules, derivations, and data extracts
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The Company
5,000 Employees

What We Do

Expanding on their combined 50-year history, Perceptive provides best-in-class specialist support to global pharmaceutical, biotech, and clinical research organizations, spanning the complete R&D lifecycle, from discovery and preclinical through clinical development to post marketing. Perceptive’s offerings include imaging biomarkers and core lab services, as well as innovative technologies in randomization and trial supply management (RTSM), analytics, and software.

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