Russell Oakley at CK Clinical is currently recruiting for a Senior Clinical Study Manager to join a global pharmaceutical manufacturer based in London, UK on a permanent basis.
This client is a global pharmaceutical manufacturer involved in the development of pharmaceuticals in the therapeutic areas of oncology, diabetes, cardiovascular and hypertension.
Senior Clinical Study Manager Job Description:
As Senior Clinical Study Manager, you will be responsible for the execution of Phase II and Phase III oncology studies according to ICH guidelines in support of the clinical strategies defined in the Integrated Development Plan (IDP) as they relate to European specific responsibilities. Support of Phase I trials may also be required.
You will be a key member of the oncology clinical team responsible for conducting clinical studies, which includes participating in writing of study protocols; total management of assigned study conduct, including oversight of the study team and CROs/other vendors; identifying and resolving study site issues; managing the study budget and study closeout with a focus on European activities
As Senior Clinical Study Manager, you may also be required to participate in the training of more junior members of staff.
The role will be based in central London but will involve international travel as well as work centred in the UK.
Qualifications, Skills and Experience:
The ideal candidate for this Senior Clinical Study Manager, you will have the following qualifications, skills and experience:
- Bachelors Degree preferably in Life Sciences, or R.N., or international equivalent.
- Demonstrable clinical trial management experience including accumulation of one year of monitoring experience required.
- Demonstrated ability to manage multiple clinical trials on time and within budget.
- Superior communication skills: written, oral, interpersonal and presentation.
- Excellent problem solving and analytical skills.
- Must work effectively in a cross-cultural matrix team environment and be flexible to contribute to the needs of the group.
- Clear, direct, tactful communication skills are required.
- Good writing skills with experience in writing study protocols, summaries, clinical brochures, FDA annual reports and other clinical documents for submission to the FDA. Writing should be clear, concise and accurately represent findings.
- Strategic thinking – Begin to participate in strategic planning. Able to anticipate potential problems and obstacles and plan accordingly.
- Ability to organize and manage a CRO and multiple sites participating in a clinical trial.
- Ability to prioritize work effectively to meet timelines.
- Demonstrates professional and effective presentation skills.
- Analytical skills – ability to identify study-related, CRO-related or site-related issues, determines the causes and possible solutions to the problem.
- Responsible for resolving issues with study conduct with appropriate staff, CRO and study sites for a clinical study.
- Solid judgment is required before applying the solutions program wide.
- Good judgment, professionalism and independence are needed in interfacing with staff, CROs, study coordinators, and investigators Interpersonal Flexibility – ability to adapt to other personalities and cultural differences, in a respectful manner that is conducive to goal achievement
- Resource Management – ability to manage internal and external vendor resources related to study trial conduct.
The following skills are not essential but would be desirable for this Senior Clinical Study Manager position:
- In depth knowledge of oncology clinical trials.
- Familiarity with MS Outlook, Word, Excel, etc.
- Participation in NDA/CTD process
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For more information regarding this Senior Clinical Study Manager job in London, please contact Russell Oakley at CK Clinical on +44 (0) 114 283 9956 or email firstname.lastname@example.org. Please quote reference CL24219 in all correspondence.