ProClinical is currently recruiting for a Clinical Study Manager job on behalf of a top 10 global pharmaceutical company located at Middlesex, UK. This is an exciting opportunity to work at a top 10 global pharmaceutical company that employs approximately 100,000 people worldwide. The organisation develops innovative products across multiple therapy areas including cardiovascular, oncology, and respiratory.
- Accountable for study execution, tracking and management of study delivery.
- Leads operational deliverables for at least two global studies and/or one project at any point in time.
- Manages feasibility and determines global study allocation to appropriate countries and sites, ensuring efficient use of resources and adherence to company policies and strategic initiatives.
- Develops and maintains the global study budget, ensuring cost effectiveness and addressing and escalating issues as appropriate.
- Ensures set up and maintenance of all systems in order to plan and implement the study and track progress.
- Ensures appropriate clinical trial supply strategy is implemented and managed.
- Develops recruitment plan, manages risk, monitors progress, and implements contingencies as required.
- Ensures efficient streamlined processes are in place to deliver study to plan and ensure safety of patients and completeness/integrity of data.
- Ensures adherence to Good Clinical Practice and all applicable local and international regulations.
- Accountable for timely delivery of scientifically and operationally robust study documents.
- In partnership with the cross functional Study Team develops a focused study protocol that meets scientific objectives and can be implemented in the clinical and regulatory environment of all participating regions to provide quality data and ensure timely study delivery.
- Ensures development, review, finalisation and delivery of high quality key clinical study documents in order to meet study timelines.
- Ensures accurate maintenance and archiving of study records.
- Accountable for clinical vendor selection/management.
- Drives assessment, selection, engagement, training and management of appropriate vendors for outsourced clinical activities/services, ensuring compliance with the company standards.
- Ensures monitoring and site personnel are familiar with all study-specific processes, procedures and systems and that training is adequately documented.
- Ensures continuous direct contact with in-country personnel to provide ongoing operational support.
- Accountable for study related communications and for resolution or escalation of operational issues.
Education, Skills and Experience:
- BSc. degree in Life Sciences, Public Health or other related discipline with extensive clinical development experience.
- A background in clinical development sciences at a CRO, pharmaceutical company or other medical environment with demonstrated leadership experience.
- Significant track record of global study management planning & delivery.
- Demonstrated ability to plan, organise and manage resources across a matrix organization to bring to successful completion specific study goals and objectives in accordance with defined quality and time based metrics.
- Proven expertise in the proactive identification of issues which may impact clinical programmes coupled with the ability to contribute to solutions affecting cross-functional matrix teams.
- Ability to work independently and proactively and to take on leadership roles on cross-functional study teams.
- Demonstrated expertise in the working with 3rd party suppliers
- Strong leadership skills
- Good communication and presentation skills
- Proven team leadership and team playing characteristics
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Matthew Pike on +44 207 4400 639 or upload your CV on our website www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.