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Clinical Study Manager
A Clinical Study Manager (also known at Study Leader, Clinical Project Manager, Clinical Trial Manager) is responsible for all aspects of a clinical trial from conception to final medical research reports. This will include managing the clinical study budget and ensuring deliverable clinical project milestones are met. The Clinical Study Manager role is challenging and multi-dimensional requiring a wide range of skills and experience. Typically, though not always, a Study Manager will have progressed from Clinical Research Associate (CRA) roles.
The Clinical Study Manager will be responsible for leading, and often forming, a cross functional clinical study team which can consist of expertise in the following areas: medical, statistical, data management, drug safety representatives, regulatory/quality, medical writers and monitoring leaders. Management of external providers such as CROs and Clinical Supplies/IRT may also be part of the role and external vendor representatives may be part of the study team.
The Clinical Study Manager will evaluate operational feasibility, oversee study protocol development and consider patient recruitment strategy resulting in a study plan which will include timelines, milestones, outsourcing requirements and the study budget. They will then be responsible for tracking against the clinical study plan and ensuring that study activities, budgetary parameters and timelines are met. An integral part of the preparation of the clinical study plans is the preparation of the requisite clinical study documents and processes including data collection tool, cliincal study monitoring plan, drug forecasting and medical research report requirements. Over the course of the clinical study the Study Manager may attend investigator site launches and meetings and perform co-monitoring activities.
A Clinical Study Manager can work in either a pharmaceutical or CRO company environment. The above is most applicable to a pharmaceutical company based role. The CRO role may not include all the above dependant on the amount of the study that is outsourced.
Study Managers may specialise in certain clinical study phases, e.g. early or late phase, and may focus on specific therapeutic areas that require unique clinicalstudy considerations such as oncology.
The Clinical Study Manager role offers progression to Global Clinical Study Manager or Programme Clinical Study Manager who are responsible for entire clinical trial programs consisting of multiple clinical studies.
Skills and Experience requred to become a Clinical Study Manager
- A life science degree
- Relevant clinical trial operational experience
- Clinical trial management and leadership experience
- In depth knowledge of clinical regulations, data integrity and budget management
- Excellent interpersonal, team leadership, decision-making and issue resolution skills
- Effective planning and organisational skills
The salary levels are variable and may depend on the typical size and complexity of clinical studies. A permanent Clinical Study Manager can expect to earn upward of £45,000 and there is a strong contract market where Clinical Study Managers will command a minimum fee of £350 to £400 per day.