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Observational Research Lead
hace 3 semanas
We are currently hiring an Observational Research Lead, who will be accountable for leadership of the Clinical function study team members and successful implementation of the Clinical Operations strategy on Observational/ Non-interventional studies in accordance with relevant Standard Operating Procedures (SOPs), study-specific procedures and applicable regulations.
**Key Accountabilities**:
- Establish efficient and effective working relationships with other functional team members.
- Provide leadership and direction to Clinical function study team members including providing performance feedback as necessary.
- Depending on assignments key accountabilities can include the following with involvement of ORL/ PL as necessary:
- Represent the Clinical function with input to project specific documents/ tools e.g. PL project plan, Central File Maintenance Plan (CFMP), client reports etc.
- Participate in client meetings (teleconference/ face to face).
- Responsible for the authorship of the Site Management Plan (SMP).
- Responsible for the authorship of the study specific training relating to the Clinical function and contribution to other functional training e.g. Contracts, Data Management.
- Oversight of resourcing needs through study lifecycle.
- Monitor study progress and take action as necessary to ensure the successful outcome of the study supporting early recognition of potential problems, escalation and implementation of contingency plans where required.
- Address identified and escalated site issues and drive to closure.
- Oversight of productivity targets for Clinical function including revenue forecasting.
- Responsible for identification of changes from original scope for the Clinical function.
- Support delivery of a quality Central File.
- Support activities as necessary in relation to audits and inspections.
- May be required to perform or support with site visits as per project needs.
- Assessment of junior staff including shadow/ assessment of calls/ visits as part of ORS Certification activities.
**Skills**:
- Excellent interpersonal, verbal and written communication skills in English (and local language as necessary).
- Excellent customer focus and able to interact professionally with a client organization and study site.
- Strong computer skills, familiar with MS-Office products including Excel, Word and PowerPoint, Clinical Trial Management and EDC systems.
- Thorough knowledge of Observational/ Non-interventional study research and relevant regulations including Good Pharmacoepidemiology Practices (GPP).
- Ability to build and lead a 'virtual' team within different cultural environments.
- Ability to work independently, seeking guidance as appropriate.
- Ability to negotiate and influence in order to achieve results whilst maintaining working relationships.
- Consistently delivers work to 'First Time Quality' whilst managing time effectively to meet metrics and/or team objectives.
- Sound problem solving and analytical skills and able to prioritize multiple tasks and achieve study timelines.
- Willing to travel locally and internationally as necessary.
- Seeks opportunities to develop experience and knowledge.
**Knowledge and Experience**:
- History of leadership responsibility with substantial Clinical Monitoring, Data Management and/or research experience.
- Solid understanding of Observational/ Non-interventional research methodology and terminology.
**Education**:
- Degree in a life science, nursing qualification or other relevant experience required.
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