Orthopaedics Senior Clinical Study Manager Role, Newbury

We are currently working with an instantly recognisable market leading medical device specialist based in Newbury who are looking to appoint a Senior Clinical Study Manager focussing on their market leading Orthopaedic Trauma and Extremities product range.

This client has an outstanding reputation and can offer amazing careers, they win countless awards as an employer and you will be able to develop within the business.

As a Senior Clinical Study Manager, you will interact directly with institutions and investigators, execute clinical research initiatives and ensure alignment with strategic goals.

You will be responsible for tasks that require a high degree of attention to detail and accuracy.

You will be working with an international team of colleagues and investigators who are driven to deliver high quality results that make an impact on the quality of healthcare around the world.

Key Duties

* Work in a virtual team environment, requiring that you be highly engaged, communicate effectively, and participate in project team meetings.
* Take lead roles in the development and execution of studies designed to support clinical evidence of device safety and performance.
* Demonstrate excellent organizational, decision-making, and time management skills in a fast-paced environment.
* Build and maintain excellent working relationships with clinical site staff, key opinion leaders and colleagues.
* Develop, maintain, and adhere to study project plans and timelines.
* Coordinate and execute research projects, including study training, site identification and initiation, ethics approval, contracting, invoicing, auditing and monitoring, and close-out activities.
* Liaise with vendors and directly managing CROs and other outsourced activities.
* Develop and track study budgets.
* Monitor study conduct and progress, proactively identify and resolve issues which may impact delivery of the study to the necessary regulations and standards, timelines, or budget.
* Ensure operational aspects of the studies are being conducted in accordance with all relevant ethical and government standards, GCPs, and Standard Operating Procedures.
* Maintain a high level of professional expertise through familiarity with scientific literature, product portfolio, and the competitive and healthcare environments.
* Execute clinical trial research, evaluate and analyze clinical data, prepare and review clinical study reports.
* Maintain clinical and regulatory files, accurate and timely tracking and documentation.
* Coordinate activities of associates and investigators to ensure compliance with protocol and overall clinical objectives.
* Support new and ongoing clinical research activities, ensure efficient and timely processing of confidentiality and clinical agreements.
* Support the development of study materials including informed consent documents, data collection tools, patient instruction guides, protocols, reports and summaries.
* Conduct clinical monitoring and/or auditing of field sites to supervise and coordinate clinical studies.

Package and Benefits

* £45 - £56 k Basic Salary
* Annual Bonus
* Pension, Medical & Wider package

Key Skills, Qualifications and Client requirements

* A minimum of a bachelor's degree (B.S. or B.A.) required, preferably with Health Sciences or other related technical discipline required.
* 3 + years' experience as a Clinical Research Associate, Clinical Project Manager.
* Fundamental knowledge and good understanding of GCPs, clinical trial design, study development and project management.
* Demonstrated interpersonal, written and oral communication skills as well as excellent organizational and time management skills in a fast-paced environment.
* Applied knowledge of project management tools

What Happens Next?
If you are interested in finding out more about this role please click the 'Apply' button. On submission of the job application form, an email alert is sent to the specialist consultant handling this role to register your interest.
All dialogue with us is in the strictest of confidence, without any obligation and we will NOT send your details to the relevant business without your consent.
Alternatively, to find out more about this role or any other roles that maybe relevant, you can email us at medicalsales@prospect-health.com or call our Medical Devices team on 01423 813456

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