Associate Clinical Data

About the job

HCLTech is a global technology company, home to more than 218,000 people across 59 countries, delivering industry-leading capabilities centered around digital, engineering, cloud and AI, powered by a broad portfolio of technology services and products.

We work with clients across all major verticals, providing industry solutions for Financial Services, Manufacturing, Life Sciences and Healthcare, Technology and Services, Telecom and Media, Retail and CPG, and Public Services.

Consolidated revenues as of 12 months ending September

• totaled $13.7 billion.

ROLE RESPONSIBILITIES

Perform activities, including but not limited to : the testing of CRF design, Database building, Acquisition & Processing of

electronic data such as external eData, Lab Data, ECG Data, PK / PD Data, etc.

Data extraction, Data Visualization; Data and

Documentation Processing, CRF and Database edit checks / validation and validation of exceptional reports / listings.

Accountable for high quality and on time delivery for assigned deliverables.

Ensure the consistent use and application of applicable data standard and ensures data quality and consistency across programs

and repositories.

Solid knowledge / understanding of the Software development, Lifecycle testing methodology; document management.

Participate in initial Data Management meetings with Clinical Data Scientist or Study Data Manager to understand the

expectation and scope of the study requirements.

Ensure work carried out in accordance with applicable standard operating procedures and working practices.

Understand the Protocol and provide input to Study Team on Database Design and Edit Check Specification as appropriate.

Review the Edit Check Specification, write UAT test Scripts.

May perform the peer review for programming checks.

May perform the QC on metadata listings.

Participate in UAT feedback meetings.

Streamline / Standardize the Scripts for Standard Forms / Edit Checks.

Validation of Manual queries / Listings (Standards / Therapeutic Specific).

Able to understand the Post Production Changes in Database during conduct and provide clinical / technical suggestion.

Track the lessons learned and share the knowledge across the team.

Complete all the documentation related to study and share it with study Team.

BASIC QUALIFICATIONS

Bachelor's degree minimum requirement.

Health Sciences experience or Technology degree preferred.

Zero to 4 years' experience in Clinical Data Management, performing complete data review activities, in a CRO or a Pharma Company.

Ability to learn clinical data management processes and principles in area of responsibility.

Demonstrates required verbal and written communication skills including ability to communicate remotely

Capable to learn technical data systems

Capable to learn how to use data visualization tools (e.g. Spotfire, J-Review)

Proficiency in the use of Microsoft Office Suite of tools (Outlook, Word, Excel, etc.)

PREFERRED QUALIFICATIONS

Experience writing test cases and performing UAT preferred

Experience within a database management role, understanding key processes and principles associated with CRF design, database set-up, edit check specification, data transfer activities is preferred

Awareness of clinical development and pharmaceuticals as a regulated industry

Awareness of healthcare regulatory authorities (e.g. FDA, Health Canada)

We offer a competitive package that includes

Life insurance

Major Medical Expenses Insurance

Minor Medical Expense Insurance

Savings Fund 13%

Food vouchers 10%

30 days as Christmas Bonus

12 days of vacation in the first year, increasing 2 days as dictated by law.

Additionally, we provide continuous training and development opportunities to help our employees achieve their professional goals.

We need Fluent English