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Job Details

Associate Director, Clinical Operations

Company: ProClinical Ltd
Location: Cambridge
Reference: CR.MP.14610
Closing Date: 19 Dec 17
Type: Contract
Salary (£): 100,000+
Benefits:

Job Summary:

A well-known global pharmaceutical company with leading products across various therapeutic areas is looking to hire an experienced Associate Director. This vacancy is an exciting opportunity to work at a top global pharmaceutical company that has a workforce of more than 6,700 employees across multiple sites in the UK. As Associate Director you will be responsible for leading the project planning and operational delivery of clinical work packages in Clinical Operations, GMD. ...

Requirements:

A well-known global pharmaceutical company with leading products across various therapeutic areas is looking to hire an experienced Associate Director. This vacancy is an exciting opportunity to work at a top global pharmaceutical company that has a workforce of more than 6,700 employees across multiple sites in the UK. As Associate Director you will be responsible for leading the project planning and operational delivery of clinical work packages in Clinical Operations, GMD. The span of activities is broad covering clinical activities in late drug development, registration/submission and post registration product maintenance phases and will include local and global working.


Job Responsibilties:

* Leading a cross functional team of clinical experts in the planning and delivery of a defined clinical project to scope, quality, budget, time, managing resource and risk (e.g. large studies/package of studies, submission planning, regulatory defense, inspection readiness, payer evidence)
* Responsible for project management including the development, baselining and maintenance of realistic, up to date and appropriate quality, project and study plans (including timings and total costs) in agreed systems (such as IMPACT, OPAL and ACCORD)
* Provide input into study feasibility, study specifications, vendor/partner contracts and essential documents such as clinical study protocols
* Lead a large/complex work package or manage a clinical study and the process to identify and solve operational issues and drive delivery to plan through internal or external partners (Alliance partners, CROs, vendors and Academic Research Organizations).
* Act as AZ operational interface with external (e.g. CRO/ARO) partners for externally managed/outsourced studies as appropriate
* Responsible for ensuring timely compliance with companywide governance controls (e.g. Sarbanes-Oxley, ACCORD access and study attestations, continuous assurance, Letter of Assurance and Clinical Trial Disclosure)
* May be assigned responsibility for leadership and program/project management of non-drug project work

Skills and Requirements:

* University degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research. Advanced degree is preferred.
* Significant experience from within the pharmaceutical industry or similar large multinational organization.
* Extensive knowledge of clinical operations, project management tools and processes
* Proven experience of clinical development / drug development process in various phases of development and therapy areas.
* Proven ability to learn by working in multiple phases, TAs and/or different development situations.
* Experience from leading clinical projects and deliverables or similar expertise from other areas of drug development (such as pharmaceutical development).
* Project management certification is desirable but not mandatory.
* Knowledge of process improvement methodology such as Lean Sigma/Change Management is desirable but not mandatory.



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: Associate Director, Clinical Operations

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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