Senior Research Consulting Manager
2 months ago
As a Senior Research Consulting Manager, you will be responsible for managing an international data management team and delivering data management services to clients and project teams related to Non-Interventional Studies. Your key responsibilities will include inspiring and leading the team, providing subject matter expertise for external client engagement and internal strategic projects, evaluating and monitoring resources, increasing operational efficiency and costs, and overseeing the implementation and management of data management systems and process improvements.
Key Duties:
- 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.
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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