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The Company
You will join a highly successful pharmaceutical organisation that is expanding through exceeding its performance, revenue, and profit targets. The organisation has a significant investment ratio in drug development with a record number of compounds in clinical studies. Oncology is the largest therapeutic area for development within the company, as it continues to enhance its position as a pioneer and innovator in this field.
The Role
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, conduct, analysis and reporting of assigned global studies and complex local studies within the established timeframes and budget, with the quality and requirements necessary for global regulatory approvals.
The Contract
The contract is for an initial 12 months and will be extendable in 12-month periods. The expectation is to work with the company for the duration of the study phase as a minimum, though they look to secure longer-term relationships with contractors. The company is highly “contractor friendly” with a significant proportion of clinical management staff being “in-sourced colleagues” who are supported through a robust on-boarding and training program. The contract provides the security of a 2-month notice period with a competitive daily rate and flexible 7- hour working day.
Experience Required
• Experience as a Clinical Study Manager, ideally for global projects
• Previous direct site monitoring experience
• Strong oncology experience
• Experience across phases I-III
• Vendor Management experience (IxRS, Central Labs, CROS etc)
• In-depth knowledge of Good Clinical Practices (GCP), federal regulations and international regulations
This role can be remote or office based and has been deemed to be inside IR35.
Expired
- Location: Reading
- Salary: Rate to be discussed
- Job Type:Contract
Posted over 2 years ago
- Sector: Clinical Operations
- Contact: Alex Butcher
- Contact Email: alex.butcher@nextphaserecruitment.com
- Contact Phone: 01403 216216
- Duration: 12.0 MONTH
- Start Date: 2021-07-28
- Job Ref: V-46964
You will join a highly successful pharmaceutical organisation that is expanding through exceeding its performance, revenue, and profit targets. The organisation has a significant investment ratio in drug development with a record number of compounds in clinical studies. Oncology is the largest therapeutic area for development within the company, as it continues to enhance its position as a pioneer and innovator in this field.
The Role
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, conduct, analysis and reporting of assigned global studies and complex local studies within the established timeframes and budget, with the quality and requirements necessary for global regulatory approvals.
The Contract
The contract is for an initial 12 months and will be extendable in 12-month periods. The expectation is to work with the company for the duration of the study phase as a minimum, though they look to secure longer-term relationships with contractors. The company is highly “contractor friendly” with a significant proportion of clinical management staff being “in-sourced colleagues” who are supported through a robust on-boarding and training program. The contract provides the security of a 2-month notice period with a competitive daily rate and flexible 7- hour working day.
Experience Required
• Experience as a Clinical Study Manager, ideally for global projects
• Previous direct site monitoring experience
• Strong oncology experience
• Experience across phases I-III
• Vendor Management experience (IxRS, Central Labs, CROS etc)
• In-depth knowledge of Good Clinical Practices (GCP), federal regulations and international regulations
This role can be remote or office based and has been deemed to be inside IR35.