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Job Details

Contract Clinical Study Manager

Company: ProClinical Ltd
Location: London
Reference: CR.MP.16304
Closing Date: 27 Apr 18
Type: Contract
Salary (£): 60,000 - 80,000
Benefits:

Job Summary:

ProClinical is working with a world leading company and is seeking a Contract Clinical Study Manager. This role is a critical role at this company, holding key responsibilities for the execution of the clinical trial and driving day-to-day activities in support of clinical trial milestones. A CTS takes on a primary role as a Regional or overall Study Lead for the company’s Clinical Operations. ...

Requirements:

ProClinical is working with a world leading company and is seeking a Contract Clinical Study Manager. This role is a critical role at this company, holding key responsibilities for the execution of the clinical trial and driving day-to-day activities in support of clinical trial milestones.

A CTS takes on a primary role as a Regional or overall Study Lead for the company’s Clinical Operations. The Regional/Study Lead leads all day-to-day Clinical Operations (CLO) functional activities associated with the execution of the global clinical trial in an assigned region (e.g. US, EU, Asia). As a Regional/ Study Lead, the CTS is responsible for oversight of the regional study team, the regional Clinical Research Organizations (CROs), and regional third-party vendors associated with the study. It is expected that the Regional/Study Lead is capable of overseeing and executing on all delegated tasks associated with clinical trial execution.

Job Responsibilities:

* Participate with Study Lead on regional study feasibility assessment activities (if applicable)
* Ensure timely development and finalization of region specific sections of study plans and manuals as per the study team charter.
* Contribute to the development and review of region specific elements of critical study documents, such as study protocol, eCRF, ICF template, and others
* Identify regional CLO risks and mitigations and share with the Study Lead
* Identify, resolve or, if necessary, escalate regional or study specific CLO issues that have a significant impact to overall global CLO study timelines, other functions, budget or quality to the Study Lead as per study team / project team charter
* Lead CLO regional study activity timeline development and contribute to regional study budget development and management
* Provide regional/local operational and regulation knowledge to Study and/or SET Lead as related to the study(ies) in support of enrolment strategies
* Provide regional study status updates to Study Lead/SET Lead
* Contribute to regional vendor evaluation and selection process
* Oversee day-to-day regional CRO and vendors’ contracted activities as per regional oversight plans
* Work with Business Operations to ensure final payments to regional vendors at study closure
* Lead site identification, qualification, selection and activation activities for the study, such as site and staff training, site budgets, site or country specific ICF and site investigator contracts
* Plan and deliver IM in collaboration with other key stakeholders

Skills and Requirements:

The CTS will be expected to demonstrate advanced communication skills, including an ability to facilitate large and small meetings across functions, as well as advanced prioritization skills. The CTS will be expected to demonstrate an ability to negotiate timelines with cross functional team members, delegate tasks appropriately, and have a strong track record of meeting commitments and delivering high quality work on time.

* BA/BS or higher in nursing, life or health sciences is preferred. Industry or relevant experience in lieu of education is considered.
* 5 years of pharmaceutical industry experience
* 4 years of experience in a CTS functional role
* Experience mentoring CRAs and CTAs is preferred

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Matthew Pike on +44 207 4400 639 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Apply for this job: Contract Clinical Study Manager

Contact Information:

Address:  ProClinical Ltd
Eldon House Eldon Street London
EC2M 7LS
England
Tel:  0800 988 4437
Fax:  +44 (0)207 834 9470
Website:  Visit Our Web Site

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