- Define and implement long term strategy in alignment with GD and Janssen R&D strategies to position the country for success.
- Accountable for attracting, planning, execution and monitoring of clinical trials through all phases (from feasibility to close-out) in conformance to ICH-GCP, relevant SOPs, other procedural documents and local regulations, ensuring inspection-readiness in UK.
- Primary point of contact for Health Authority agencies for activities related to clinical operations.
- Country legal representative for GCO related activities (authorized to sign contracts and agreements).
- Accountable for functional budget and affiliate funding in compliance with relevant financial processes
- Shape and maintain strong relationships within GD and Local Operating Company (particularly with Medical Affairs). Might participate in Local Operating Company Management Board and Regional Management Teams
- Develop country capabilities for effective study placement
- Champion a culture of continuous improvement and innovation. Contribute to development and evaluation of new processes and standards to improve clinical trial management as well as lead their rollout in the country
- Ensure quality and performance oversight in the country
- Model Credo-based culture within the local GCO team
- Contribute to shaping environment for clinical trials in UK (e.g. through involvement in pharma industry associations)
- Provide line management to direct reports including setting goals and objectives, performance evaluation and talent development
- Evaluate and forecast overall resource needs for the country
- Ensure an efficient utilisation of flex model at the country
- Interview, hire, develop and train staff
- Strongly demonstrate leadership behaviors demonstrative of J&J Leadership Imperatives
- Champion an environment that encourages sharing of ideas, information and share findings
- Provide coaching or mentorship as needed
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Country Head UK, Global Clinical Operations - High Wycombe, United Kingdom - Johnson & Johnson
Description
Country Head UK, Global Clinical OperationsJohnson & Johnson Innovative Medicine has an ambitious vision to integrate digital into the core of how we work amplifying our core capabilities and making a positive difference to the lives of patients, healthcare professionals, our employees and our communities. We have an exciting opportunity for a Country Head located within commutable distance of High Wycombe, UK, to lead our Global Clinical Operations (GCO) team in the UK within our wider Global Development (GD) business.
The Country Head UK GCO is accountable for strategic and operational management of clinical research and development activities in the UK and the successful country execution of all phases of clinical trials, including resource allocation, adherence to timelines and budget, compliance with relevant Standard Operating Procedures (SOPs), policies, Health Care Compliance (HCC) and local regulatory requirements. The Country Head UK GCO shapes and manages local organisational structure to ensure its optimal efficiency and demonstrates an effective issue management within the country and across countries. This role is responsible for line management of Functional Managers and other GCO staff, as required. Ensures alignment of local goals with organisational objectives. Drives innovative solutions and process improvements for the country/region or GCO/ Global Development (GD) overall.
Principal Responsibilities:
Key Working Relationships:
The incumbent will report directly to the Cluster Head or Regional Head, maintaining active collaboration with Functional Managers, Regional/Cluster Heads, and fellow Local R&D Heads within the cluster/region. Seamless interaction is also expected with other GCO staff across the country, including R&D and Local Operating Company teams, encompassing Medical Affairs. Additionally, the role involves establishing effective connections with various departments both within and outside of GCO/GD, such as Delivery Units, Regional Therapeutic Area Experts, Information Sciences, Data management, Quality and Compliance, Health Care Compliance, External Alliances, Contracts and Grants, and other relevant stakeholders. Externally, the Country Head UK will be responsible for managing relationships with flex providers, Health Authorities, local pharmaceutical industry associations, investigational sites, local vendors, and other pertinent entities as necessary.
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