Observational Research Leader / Clinical Lead (RWE - Observational)
Parexel International Corporation
Spain - Any Region - Home Based
We are recruiting for a European based Observational Research Leader, otherwise known as Clinical Lead for RWE. You 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.
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:
o Represent the Clinical function with input to project specific documents/ tools e.g. PL project plan, Central File Maintenance Plan (CFMP), client reports etc.
o Participate in client meetings (teleconference/ face to face).
o Responsible for the authorship of the Site Management Plan (SMP).
o 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.
o Oversight of resourcing needs through study lifecycle.
o 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.
o Address identified and escalated site issues and drive to closure.
o Oversight of productivity targets for Clinical function including revenue forecasting.
o Responsible for identification of changes from original scope for the Clinical function.
o Support delivery of a quality Central File.
o Support activities as necessary in relation to audits and inspections.
o May be required to perform or support with site visits as per project needs.
o Assessment of junior staff including shadow/ assessment of calls/ visits as part of ORS
- Excellent interpersonal, verbal and written communication skills in English (and local language as
- Excellent customer focus and able to interact professionally with a client organization and study
- 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
- 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
- Willing to travel locally and internationally as necessary.
-Seeks opportunities to develop experience and knowledge making suggestions to enhance
- Effectively applies knowledge to provide advice or solution based on expertise and experience.
Ability to provide support and constructive support to study team members and dept colleagues.
History of leadership and responsibility with substantial Clinical Monitoring, Data Management and /or Research Experience.
Solid understanding of Observational /Non Interventional Research methodology and terminology.
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