Research Consulting Snr Manager

2 weeks ago


Singapur, Singapore Oracle Full time

Senior Research Consulting Manager, Clinical Data Management

Location: Singapore

Key Purpose:

The Senior Research Consulting Manager Clinical Data Management & Safety is responsible for managing an international data management team and delivering data management services to clients and project teams related to Non-Interventional Studies.

The Senior Research Consulting Manager is responsible to manage and motivate the team in a spirit of a growth mindset for people. Inspirational and open to a global culture, The Senior Consulting Manager acts as a leader within the global RWE/Clinical domain.

The Senior Research Consulting Manager develops and implements data management strategy and organization to increase productivity and quality, while decreasing cycle times and costs. As part of his role, The Senior Consulting Manager provides oversight of project-related data management tasks and is part of different governance groups linked to strategic projects and customers. He is, as well, responsible for optimizing the work allocation across the team, and for adapting the activity to any new regulations.

As part of the strategy, The Senior Research Consulting Manager has an innovation mindset when it comes to integrate new technologies in Data Management activities.

Primary Duties + Responsibility:

Inspire and lead an international Data management team. Subject Matter Expert (SME) for external client's engagement & internal strategic projects. Interact with clients, to provide a high standard of customer service and ensure complete understanding data management / database development and Safety responsibilities. Evaluate and monitor resources. Increase operational efficiency and costs. Oversee the implementation and management of data management systems and evaluate process improvements and innovative methods for clinical data management. Oversee projects, actively part of escalation processes and involve in clients' audits. Support the development and implementation of Data Management & Database Development Standard Operating Procedures (SOPs), guidelines, policies, procedures and requirements, and ensure personnel are trained appropriately. Represent Data Management in marketing efforts by developing project bid proposals, participating at bid defense meetings or performing client presentations as requested.

Experience & Minimum Requirements:

Thorough knowledge of International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) guidelines and other applicable regulatory rules and guidelines as well as of medical terminology, clinical trials, and clinical research. Working knowledge of the relationship and regulatory obligation of the contract research organization (CRO) industry with pharmaceutical / biotech companies. Skilled in use of computer technology, including clinical trial databases and applications and ability to learn new applications. Experience in C-DISC requirements Demonstrated ability to lead by example and demonstrated skill for technical and supervisory leadership of staff. Excellent interpersonal, communication, and organizational skills with the ability to work independently and in a global team environment. Computational knowledge and knowledge in HEOR, Market access and secondary data would be a plus.

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