The Clinical Data Manager is responsible for overseeing all data management activities pertaining to the conduct of Phase I-IV clinical trials in accordance with ICH/Valuable Clinical Practices (GCP) and other relevant procedures and guidelines to ensure that a quality work product is produced and timelines and deliverables are met.

Job Responsibilities

Participate

- - T As the primary data management representative on the QED multidisciplinary project teams.
- As the primary point of contact for all data management interactions with the Sponsor.
- In protocol developments and review
- In review of clinical study reports and statistical analysis plan
- In the development of data dictionaries complete with variables, value specifications and coding standards
- In monitoring the quality of data management processes, data and performance

Review and provide
- - Inputs to CRF design and CRF Completion Instructions
- Database design, data management/data validation plans and data entry guidelines
- Revisions to the Standard Operating Procedures

Manage
- - Resource planning methodologies and project management
- To ensure study deliverables and timelines are met in collaboration with the Sponsor
- The Sponsor change order process




- To ensure effective communication exchange between the multidisciplinary project teams

Assist/Work with Sr. Management
- - In identifying, developing and implementing processes to improve/enhance time and cost efficiencies
- To provide current information and potential impact of changes on project deliverables and timelines
- To identify trouble-shoot issues and provide proposed solutions for problem resolution
- To evaluate future potential data management solutions (e.g functional service provider models, EDC systems) and prepare a business plan
- To individual development, training, knowledge and expertise through research, technical bulletins and attending appropriate seminar

- Endorse and convey QED's corporate mission statement

Qualifications/Experience

- Bachelor's/Master's degree in a computer science, statistics, clinical research, biotechnology, from an appropriately accredited institution..
- Minimum of 5 years of data management experience
- Project management experience is required.
- Work history at a Clinical Research Organization (CRO) or CRO management experience in data management is required.
- Direct management of employees within Clinical Data Management is preferred.

📌 Clinical Data Manager (India)
🏢 QED Pharmaceutical Services
📍 India