Clinical Operations and Projects Manager

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Job description

We've got a great role with an expanding clinical research organisation (CRO) who have an exciting site network and technology platform. You should be a good team manager and project manager.

*Our client is looking for a Operational and Global Studies Lead who can join their team based in west London. Their clinical research has focused on Cardiovascular studies in late phase and Real World data but they are now growing across more operational areas and phases. They also have an innovative data platform to help connect and keep in contact with sites. *

*The role is to ensure that the client's operations team perform and deliver internal, external projects and studies in an efficient and effective manner and to the highest standards while remaining within the ICH-GCP guidelines.*.

*Key Responsibilities: *

* Lead the operations team by providing global oversight during the various stages of project delivery to ensure that projects are performed and conducted in compliance with ICH-GCP guidelines, SOPs and all applicable regulatory requirements

* Oversight of status reporting of study targets discussed and agreed by the operations team, includes the development of study timelines, communication, risk and quality plans, team training and oversight

* Accountable for status of study/ies and that these are communicated regularly with the study team and management and that unresolved issues are escalated appropriately

* Ensure specific and robust contracts are negotiated and set up

* Develop protocols in conjunction with Chief Operating Officer and Investigators

* Attend and contribution to Investigator meetings

* Support the operational team in the training of site ensuring they are trained in protocol specific procedures

* Liaise with external customers e.g. Steering Committees, Investigators, Study Nurses and Clinical Trial Pharmacists etc as required.

* Provide operational oversight/management of CROs and vendors ensuring delivery against contracted scope of work for the allocated region

* Provide support to the Clinical Project Managers during the planning and finalisation of study budgets

* Coordinate the development of program level documents, plans, and metrics reports

* Implement a culture & program of continuous improvement

* Monitor operational progress and address and manage obstacles/challenges

* Serve as primary contact for the operational team and liaise with senior management for the operational teams

* Provide operational oversight of internal projects improving process and delivery

* Drive and lead the successful execution of operational components across various functional teams using strong project management, communication and organizational skills.

*Desired Skills and Experience: *

* A highly experienced candidate having attained a senior position (AD/Dir) within a CRO / Pharma company

* Experience of independently leading clinical project management teams and / or cross functional operational teams and at least 3-5 years in a leadership position directing the operations of global clinical programs

* Strategic analytical thinking and decision making skills

* Strong program planning and project management skills, including project and business finances

* Proven clinical trials project management and leadership experience

* Proven practical experience in the areas of operations and project management

* Strong and proven customer engagement and executive communications

* Understanding of business strategy, technologies and their applications

* Ability to influence, build consensus and manage conflict in challenging situations

* Self-starter and proven team player

* Life science or other relevant degree

* Excellent organizational skills, including strong leadership skills and capabilities

* Proven ability to develop and update working practices

* Flexible and effective project management, communication and negotiation skills

* Ideally experienced in overseeing outsourced CRO work

* Ideally a strong understanding of cardio vascular disease and treatment

* Strong interpersonal skills

* Effective oral and written communication skills

* Proven teambuilding skills and ability to foster partnerships across projects and multidisciplinary teams

* Appropriate working knowledge of GPP, GCP and the regulatory framework for clinical research

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