Clinical Data Manager - Pharmaceutical

Industry - Healthcare / Medical / Hospital

Category - IT & Systems

Job Type - Permanent

Job Description :

- Clinical Data Manager is responsible for managing the clinical database of TPCL, customizing the data formats/ systems based on clinical requirements, ensuring data accuracy and quality, undertaking analysis to track the progress and outcomes, and issuing periodic reports on clinical studies.

Client Details

Our client is a Fortune 500 organisation and is ranked amongst Top 20 Pharmaceutical Companies in the World. By business revenue they are the largest in Asia, earning to the tune of 19.29 billion US Dollars. Currently looking at expanding their operations in India they are actively looking out for experienced professionals in the clinical trial & research space.

Description

- Planning and Development of Clinical Database

- To support clinical operations team in planning, designing and development of clinical database management processes/ systems. To supervise and coordinate with the CRO team to customize clinical database, as required

- To develop Data Management Plan (DMP), according to clinical study design / requirements and quality and regulatory requirements, and ensure that it is followed throughoutlifecycle of clinical study

- Data Collection, Quality Review and Query Generation

- To collate and review the data received from multiple sources for all ongoing/ closed clinical studies, and update the database, in case of errors. To highlight any discrepancies in the data to CA Team/ CROs and ensure that these are addressed in a timely manner

- To cross-reference database records against paper records or contact details of person(s) who can verify the accuracy of specific data, as required

- To run queries, based on the clinical study requirements, and analyse the data to track progress and outcomes of the clinical studies

- To ensure that the protocol for data management is followed and data is reported accurately and as per schedule, and scientific integrity of the data collected is protected and verified

- To support in development and sign-off on Data Transfer Agreement(s) (DTAs) with the CROs, external data vendors and other stakeholders, as required

- To regularly update eTMF (electronic Trial Master File) and CTMS (Clinical Trial Management System) for all clinical studies, as per the guidelines

- To perform close-out audit, as specified, for closing of study trial through the clinical database management system

Profile

- B. Tech./ M.Sc. (Computer Science or IT) 8-10 years experience in Healthcare/ Life sciences/ clinical trial industry

Knowledge of clinical operations

- Trained or Certified in clinical trial SOPs (Phase II-Phase IV), ICMR, ICH-GCP, Schedule Y and Indian regulatory guidelines

- Trained in data management SOPs, CTMS

- Analytical skills

Job Offer : 

An opportunity to work with a Leading Multinational Brand within the Pharmaceutical & Clinical Research Industry

An opportunity work closely with the Senior Leadership team in a dynamic & progressive work environment

To apply online please click the 'Apply' button below. For a confidential discussion about this role please contact Rhea Nair on +91 124 452 5488

Contact - Rhea Nair - +91 124 452 5488

The Apply Button will redirect you to website. Please apply there as well.