Lead Data Manager: Clinical Data Management

8 - 10 Years
Bengaluru

Job Description

1. Responsible for end to end Clinical Data Management services for all clinical studies conducted/ outsourced by The Himalaya Drug Company (Clinical Database Set Up to Database Lock viz. Study Designing/Clinical Study Conduct/ Study Close Out).
2. Develop the SOPs, TOMs (Technical Operating Manuals), Presentations on all CDM system & process.
3. Review and provide inputs in the clinical trial documents related to Clinical Data Management sections (eg. Protocols, Case Report Forms, SAE reconciliation etc)
4. Evaluate and validate the CDM Tools (paper based CDMS or EDC systems) as in-house or outsourced model.
5. Responsible for the development of the Data Management Plan (DMP) across projects and maintain throughout lifecycle of study project to ensure DMP is followed according to study design and requirements.
6. Develop/ contribute/ Review study data specifications, including eCRF design, user requirements, edit rules/checks, query logic and data validations.Oversee the User Acceptance Testing (UAT) by team and Coordinating UAT of eCRF build and validation documents, included but not limited to: edit check document, issue logs, UAT summary report.
7. Assist in reconciling AE/SAE data in Safety DB and/or other Data Management DB
8. Highlight the need for training programs (technical and professional skills) for clinical Data Management staff and ensure staff training is conducted and properly documented.
9. Support recruitment of resources. Provide leadership to team, setting team KRAs, completing task allocation and completion sheet, determine resource needs, identify and justify.
10. Identify gaps and suggest process improvements (internal/external) on an ongoing basis.
11. Ensures data system compliance by following the established guidelines of national and international regulatory authorities. Helps to identify and troubleshoot operational problems, issues, obstacles, and barriers for studies and programs; Working with appropriate teams towards action and ensuring resolution

Required Candidate profile

  • Bachelors or higher degree with minimum 10 years of progressive experience in clinical data management within Pharmaceutical, Biotech or CRO industry.
  • Hands on experience in developing the system and process related to data management activities for clinical trials.
  • Experience working in an in-house and outsourced data management model
  • Knowledge of and experience with EDC databases, CDASH/SDTM standards, medical terminology, medical coding dictionaries (MedDRA, WHO-DD), and quality control processes
  • Familiarity with GCP, ICH and FDA requirements as applicable for clinical data management

Keyskills

Desired Candidate Profile

Please refer to the Job description above

Education-

Doctorate:Doctorate Not Required

Company Profile

The Himalaya Drug Company

Working in Himalayas means to learn and grow continuously.Opportunities to work on the finest ever products in the herbal space, competitive salaries and excellent benefits. We offer challenging assignments, a world class working environment, professional management and ample prospects to train and learn along with exceptional rewards.
View Contact Details+

Recruiter Name:HR TEAM

Contact Company:The Himalaya Drug Company

Salary

Not Disclosed by Recruiter

Functional Area

Other

Employment Type

Full Time, Permanent