Lead Clinical Data Specialist

1 week ago

Bengaluru, Karnataka, India Excelya Full time

We are seeking a highly skilled Senior Clinical Data Manager to join our team in Bangalore, India.

About Excelya

Excelya is one of the leading Contract Research Organizations (CROs) in Europe, founded in 2014 and headquartered in Paris. Our global team consists of over 900 experts who understand the critical needs of clients and provide trial solutions across a broad spectrum of therapeutic areas.

We take a collaborative approach to work, where our shared success is the result of teamwork at every stage of a project, from regulatory affairs and clinical operations to quality assurance and strategic development.

Our vision is to achieve new advances in the field of healthcare and expertise in research development. We aim to help our clients deliver life-changing therapies collaboratively, so we can transform tomorrow together and become the clinical research leader in Europe.

We commit to giving each Excelyate the means to express their natural talents, develop their full potential, and invest their unique selves in our unique projects.

To learn more about us, please visit our website.

Senior Clinical Data Manager Job Description

The Senior Clinical Data Manager will be responsible for performing data management tasks per client work orders to high regulatory standards and Client SOPs.

Key Responsibilities:

  • Deeply acknowledges and strictly follows applicable Excelya and Client's SOPs.
  • Responsible for data cleaning, data review, discrepancy management, and data reconciliation activities on the studies assigned.
  • Works closely with the Lead Data Manager responsible for the study.
  • Generates study metrics and status reports within and across several studies.
  • Participates in EDC database build and testing through go live.
  • May act as a Lead Data Manager on simple studies.
Requirements

To be successful in this role, you will need:

  • A Bachelor's degree qualification in a Scientific discipline.
  • Five or more years of experience as a Data Manager or equivalent combination of education, training, and experience.
  • Knowledge and understanding of ICH GCP and other relevant ICH, EU, or FDA guidelines to maintain regulatory compliance.
  • Understanding of recommended CDM best practices and associated documentation.
  • Experience in clinical trial databases and applications, clinical data flow, data review, and eCase Report Form design.
  • Understanding of clinical trials and study lifecycle (start-up, maintenance & closeout).
  • Proficient in computer technology used in an office environment (Word, Excel, PowerPoint, MS Project, etc.).
  • Ability to maintain a high level of professionalism, ethics, and compliance at all times.
  • Effective verbal and written communication skills.
  • Fluent in local language and English (written and verbal).

We offer a competitive salary range of ₹1200000 - ₹1800000 per annum based on experience, plus additional benefits including health insurance, retirement plan, and opportunities for professional growth and development.

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