Manager, Study Data
Bengaluru, Karnataka, in
3d ago
source : JobSearchine

Are you energized by a clinical education role that allows you to build industry-leading medical capabilities through an integrated professional development framework?

If so, this Clinical Support Manager role could be an exciting opportunity to explore.

To direct the data management activities at the asset, project or study level in support of GSK’s medicine development strategy.

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following :

Single point of accountability for data management deliverables at an assigned level (asset, project or study) within a given clinical development program.

Expert input to protocol and other plans e.g. Protocol Deviation Management Plan, Monitoring Plan and Reporting & Analysis Plan, at the development phase of a study.

Owner and author of Data Management Plan and accountable for the execution of this plan throughout the lifecycle of the study.

Determines the data requirements for a clinical study, including the eCRF, laboratory and eCOA Development and management of study validation and integration plans, including the, dataset definition for external data sources.

Lead role in the management of the data vendor deliverables and performance.

Ensures data integrity from source through to submission, publication and archiving. Accountable for the set-up and maintenance of TMF section 10 and DM TMF artefacts throughout the study life cycle.

Participates in due diligence activities and risk assessments with specific emphasis on the data management and data quality aspects for new acquisitions, in-licensing agreements and new partner relationships.

Subject Matter Expert for the Data Management Community in a specified area(s) of functional expertise, which can include expert input to the development, implementation and communication of control documents.

Why you?

Basic Qualifications :

We are looking for professionals with these required skills to achieve our goals :

Post Graduate Degree in Scientific Discipline

Clinical trial experience.

Knowledge of the principles of quality, safety, risk management and compliance (ICH and GCP). Understanding of the tools of the trade, such as standards.

End-to-end global medicine development experience.

Business acumen demonstrated by understanding the implications of decisions and uses this knowledge to plan, implement and manage data management issues, projects and processes that are aligned with business needs.

Pharma, CRO and / or ARO experience. Demonstrates expertise in the identification, evaluation and selection of key global preferred provider partnerships.

Ensures final contracts meet all technical and performance requirements for the appropriate business level, (asset, project or study).

Understanding of local regulatory environment and commercial needs at applicable country levels relevant to assigned studies and projects

Understanding and compliance with ICH GCP, and applicable policies and SOPs.

Knowledge of disease area. Demonstrates a current, in-depth understanding of the relevant medicine and associated therapy area.

Demonstrates the project management disciplines of planning, organizing and managing resources to bring about the successful completion of specific project goals and objectives in accordance with defined quality and time based metrics

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