Senior Clinical Study Manager
Date Posted: Wednesday, 15th of February 2012
Salary: Competitive
Start Date: ASAP
Telephone: 0114 2839956
Location: London
Discipline:Clinical Operations
Consultant Name: Russell Oakley
Description
Our client is global pharmaceutical manufacturer involved in the development of pharmaceuticals in the therapeutic areas of oncology, diabetes, cardiovascular and hypertension.
The company are currently looking to appoint two permanent Clinical Study Managers, one of these being at Senior Study Management level. The roles will be based in central London but will involve international travel as well as work centred in the UK.
The purpose of this position/s is to 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.
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
May participate in training of junior personnel.
The ideal candidate for the position will have:
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.
It is desirable to have:
In depth knowledge of oncology clinical trials.
Familiarity with MS Outlook, Word, Excel, etc.
Participation in NDA/CTD process
Skills:
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 tothe 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 independenceare 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.
CK Clinical 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 CL23723 in all^correspondence.
Keywords: Oncology, CPM, CSM, Study Management, Clinical, Clinical Recruitment
