- Contract Study Leader / Manager for global oncology study
- Home based in the UK, or can be office based if you prefer in Reading
- Plan, implement and manage study including study team leadership and budget management
- Initial 12 month contract with client approved outside IR35 contract
- Long contract anticipated with many of our contractors in their 3rd, 4th and 5th years
- Competitive day rate with the security of 2 month notice period
- Flexible start date to accommodate notice period /end of contract dates in current position
- Oncology TA experience leading international studies is essential
The company is a highly successful pharmaceutical organisation that is expanding through exceeding performance targets. The organisation has a high investment ratio in drug development with a record number of compounds in clinical studies and more planned. Oncology is a strategic therapeutic area where the company has further clinical trial funding as it continues to enhance its position as a pioneer in this field.
The company are expanding oncology clinical activities with a number of new compounds coming into studies and approval for further phase studies for other compounds. The role involves ownership of a phase 1, 2 or 3 study to be run in multiple countries (Europe and Asia Pacific at least) dependent on patient availability. The study will be complex in nature and involve an emphasis on aspects such as patient recruitment strategy and data quality.
The Study Manager is responsible for all aspects of the assigned study from conception to final medical report including the budget and measurable deliverables. The responsibilities encompass all aspects of the planning, implementation, analysis and reporting of the study within the timelines and budgets. An important element is the identification and management of a cross-functional international team including medical, statistical, monitor leading, CTS/IRT, data management, safety, regulatory and medical writing expertise. There will be an initial focus on patient recruitment strategy and ongoing emphasis on quality of data. A full job specification is available on request.
The contract will be for an initial 12 months, extendable for 12 month periods usually re-contracted at the start of month 10. The expectation will be to work with the company for the duration of the study phase as a minimum however the company is looking to secure long term relationships with contracts. Due to the project anonymity we provide a client approved, outside of IR35 contract. The company is very “contractor friendly” with a significant proportion of clinical staff being “in-sourced colleagues”. They offer genuine development opportunities and recognise achievement through long term assignments. The contract provides the security of a 2 month notice period with a highly competitive daily rate and flexible 7 hour working day.
We are able to accommodate current notice periods / end of contracts with a flexible start date; securing the right candidate for this long-term placement is of prime importance.
We are seeking a committed individual with global / international clinical trial management and leadership experience. Due to the nature of the study we do require expertise in the Oncology area (this is essential) which will encompass experience of regulations, data development processes and budget parameters. Due to the international nature of the studies and study team you will need to demonstrate a strong appreciation of working with a variety of cultures. Candidates will be considered from pharmaceutical, bio-tech, CRO and not-for-profit company environments.
Clinical Study Leader, Clinical Study Manager, Study Lead, Clinical Project Manager, Senior Clinical Project Manager, Global Clinical Project Manager, Clinical Trial Manager, Oncology, Haematology, Home Based, United Kingdom, England, M4 Corridor, Reading, Berkshire,
This is a contract position.