Lucy Stendall is recruiting for a Clinical Study Manager in HIV to join a world leading pharmaceutical company at their site based in Uxbridge on a contract basis for 12 months.
The main purpose of the role will be:
• To be accountable for study execution, tracking and management of study delivery.
• Leading operational deliverables for at least two global studies and/or one project at any point in time.
• Managing feasibility and determining global study allocation to appropriate countries and sites, ensuring efficient use of resources and adherence to company policies and strategic initiatives.
• Developing and maintaining the global study budget, ensuring cost effectiveness and addressing and escalating issues as appropriate.
• Ensuring set up and maintenance of all systems in order to plan and implement the study and track progress.
• Ensuring appropriate clinical trial supply strategy is implemented and managed.
• Developing recruitment plan, managing risk, monitoring progress, and implementing contingencies as required.
• Ensuring efficient streamlined processes are in place to deliver study to plan and ensure safety of patients and completeness/integrity of data.
• Ensuring adherence to Good Clinical Practice and all applicable local and international regulations.
• Accountability for timely delivery of scientifically and operationally robust study documents.
• In partnership with the cross functional Study Team develop 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.
• Ensuring development, review, finalisation and delivery of high quality key clinical study documents in order to meet study timelines.
• Ensuring accurate maintenance and archiving of study records.
• Accountability for clinical vendor selection/management.
• Driving assessment, selection, engagement, training and management of appropriate vendors for outsourced clinical activities/services, ensuring compliance with company standards.
• Ensuring global feasibility of contractual agreements.
• Accountability for site and monitor training in operational aspects of the study.
• Ensuring monitoring and site personnel are familiar with all study-specific processes, procedures and systems and that training is adequately documented.
• Ensuring continuous direct contact with in-country personnel to provide ongoing operational support.
• Accountability for study related communications and for resolution or escalation of operational issues.
• Developing study communication plan to ensure efficient and appropriate global communication to all internal and external stakeholders.
• Ensuring processes are in place to address or escalate study issues as they arise.
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- 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 organisation to bring to successful completion specific study goals and objectives in accordance with defined quality and time based metrics.
- Demonstrated expertise in the working with 3rd party suppliers
Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference KA42598 in all correspondence.
You must be eligible to work in the UK. Learn more
- Agency: CK Group (Science, Clinical, Engineers and IT Recruitment)
- Contact: Lucy Stendall
- Phone: 01246 457733
- Reference: KA42598
- Posted: 27th June 2018
- Expires: 25th July 2018