Purpose/Objective of the job
This role will be the strategic and operational partner to the Head of Regional Clinical Operations Asia/Americas/Europe and specifically support the management of budget, resources, study country allocation, study execution performance, strategic efforts and communications.
Key Responsibilities and Major Duties
- Assist functional leaders in delivering transformative operating model enhancements that improve pipeline delivery and enhance business performance
- Assisting functional leaders in the design and implementation of short- and long-term business strategies
- Manage resourcing model for the region and help manage workforce management plan in collaboration with CTP&OE and RDSP
- Manages regional budget to ensure proper and efficient use of allocated budget
- Support communication flow and plan for the region, including creating materials for regional and global meetings. Work with Country Clinical Operations Heads to plan annual Lead Country Unit Meetings
- Assure that initiatives within the region are kept on track and managed effectively through use of formal Charter review and approval process, and oversight involvement in key global initiatives
- Drive & coordinate regional input to the synopsis, country allocation & site identification at the country-level with CTP&OE & Country Clinical Operations Head, and be responsible for the creation of the operational execution plan across the region in collaboration with CTP&OE
- Line management of one or more Vendor Operations Managers, assuring the application of a unified and robust Vendor management & oversight process for countries with challenging clinical outsourcing environments in the region.
- Drive & coordinate regional review of study execution progress and overall performance metrics.
- Work with RCO Head to implement strategies to develop people and culture in alignment with GCO and company
(Disclaimer: The responsibilities listed above are only a summary and other responsibilities will be requirements as assigned)
Direct line management of Vendor Operations Manager(s)
Major customers are study teams across R&D including senior managers as well as external customers e.g. CROs, academic institutions, and other external suppliers.
List of minimum requirements
Bachelors or Masters Degree within life sciences or equivalent
- Minimum 8-10 years of relevant commercial experience in pharmaceutical or healthcare related industry required.
- Proven project management experience, with a strong background in the operational aspects of clinical research studies.
- Experience in resource planning, budgeting techniques and process improvement preferred.
- An in-depth understanding of clinical research processes and regulations.
- Ability to work independently in a fast moving and increasingly complex environment with limited direction is required
- Position requires very strong written and oral communication skills, as well as strong interpersonal and organizational skills.
- Individual must possess the ability to build alignment and drive performance across matrix teams through personal influence.
- Demonstrates the ability to lead and motivate team members according to strategic goals.
- Good verbal and written communication skills (both in English and local language).
Software that must be used independently and without assistance (e.g., Microsoft Suite)
- Microsoft Suite
- Clinical Trial Management Systems
Travel Required –
- Domestic travel to clinical trial sites
- International travel where required