Regional Manager, Clinical Study Support, Open to flexibility
Regional Manager, Clinical Study Support, Open to flexibility
The Regional Manager, Clinical Study Support position is accountable for providing leadership, oversight, development, direction and coordination of clinical study support activities and also direct relationship management of our FSP supporting CSS and TMF activities.
This is a position in the Global Clinical Study Support team, reporting to the Head of Global Clinical Study Support. The Regional Manager, Clinical Study Support will help set the strategy and direction for the management of interfaces internal to PCPS TA Units, and external FSP/FSO Suppliers and Partners and coordination with clinical documentation operations.
- Leads a team that will be supporting GSK sponsored, Phase I - IV studies and projects. Interacts with internal matrix partners and our Full Service Providers. In addition they will also have responsibilities for direct line management of a large team.
- Accountable for the implementation and embedding of the Clinical Study Support flexible resource model and eTMF support model supported by our FSP. This includes but is not limited to the implementation and embedding of standard systems, processes and procedures for the requesting of Clinical Study Support resource, eTMF support resource and workload forecasting and capacity planning and assignments for eTMF support and clinical study support activities.
- Have a broad understanding of TMF and experience working with CROs.
- Accountable for implementing the new eTMF support model. Act as a POC for FSP and conduct a review / evaluation of the FSP who provide Clinical study support staff to ensure that they are able to perform on the agreed activities to the expected standard.
- Accountable for the identification of appropriate capable resources to support the workload and personal development opportunities for eTMF support model and for global Clinical Study Support staff to support R&D strategies within PCPS.
- Accountable for building strong collaborative partnerships with FSP and internal stakeholders ie: GCSO, CPSSO, and CDO to enable in-stream, end to end process flow
- Ability to prioritize business needs and flexibly address them; lead through change
- Accountable for ensuring that their team adheres to appropriate Regulatory e.g. ICH GCP, GSK Policies, SOPS, standards and have relevant documentation in place and tracked to demonstrate this.
- Drive and ensure an effective model is in place to support the implementation of eTMF across Pharma R&D
- Responsible for ensuring staff work to the highest quality that enables study teams to be 'Inspection ready' at all times.
- Accountable for ensuring that global Clinical Study Support staff and eTMF support apply their specialized knowledge of GSK systems processes and procedures, when conducting GSK sponsored studies and projects to agreed quality, timelines, milestones and budget.
- Responsible for ensuring that Clinical Study Support staff and eTMF supports staff share best practices and serve as a change agents for GSK both internally and externally.
- B.S degree or equivalent experience with at least 5 years working in the pharmaceutical /healthcare industry / academia / hospital /clinic in clinical development role.
- Experience or expertise working in a Clinical Study Support leadership role e.g. as a Supervisor/Manager.
- Experience leading relatively large teams in a matrix environment.
- The person should have held a Managerial or leadership position in pharma or health care and had positions which included developing staff and leading and implementing change.
- Strategic thinking and the ability to manage a large team
- Organisational, planning, and business acumen skills
- Communication skills, both written and oral
- Ability to prioritise business needs and flexibly address them; lead through change
- Ability to flex/adapt to changing business priorities and customer needs
- Ability to integrate and distill complex information into simple actionable conclusions
- Working across boundaries and geographies
At GSK, our mission is to improve the quality of human life by enabling people to do more, feel better and live longer. Our three world-leading businesses research and deliver innovative medicines, vaccines and consumer healthcare products. We need a talented and motivated workforce to deliver against our strategy. To achieve this, we strive to attract the best people and to create an environment that empowers and inspires.
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