Associate Director, Clinical Operations

£0.00 - £625 per hour
  1. Contract
  2. Clinical Research Associate (CRA), Program Manager / Director
  3. United Kingdom
Cambridge, Cambridgeshire
Posting date: 12 Feb 2019
CR.MP.21681_1549995072

ProClinical is currently recruiting for an Associate Director, Clinical Operations position at a global pharmaceutical company across various therapeutic areas. This top 10 company is looking for someone to join their team in Cambridge.

The Associate Director, Clinical Operations (ADCO) will be responsible for leading the project planning and operational delivery of clinical work packages in Clinical Operations. This will include late drug development, registration/submission, and post registration product maintenance phases, and will include local and global working. They will lead and manage defined clinical deliverables across a broad range of activities, which can include the responsibility to lead complex components of a clinical program, such as Life Cycle Management, clinical submission activities, indication development responsibilities, leading independent work programmes, and project management of the scope, schedule, and budget. In addition to clinical work in drug projects, the ADCO may manage improve or change projects in other business areas, all whilst being responsible to the Director Clinical Development.

Job Responsibilities:

  • 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.
  • Overseeing project management, including the development, baselining, and maintaining 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 ACCORDS.
  • Providing input into study feasibility, study specifications, vendor/partner contracts and essential documents such as clinical study protocols.
  • Leading a large/complex work package or managing a clinical study and the process to identify and solve operational issues and drive delivery to plan through internal or external partners.
  • Acting as the company operation interface with external partners for externally managed/outsourced studies as appropriate.
  • Ensuring timely compliance with companywide governance controls.
  • May be assigned responsibility for leadership and program/project management of non-drug project work.

Skills and Requirements:

  • A university degree in medical or biological sciences or other field related to clinical research. An advanced degree is preferred. Equivalent experience in lieu of a degree will also be considered.
  • Significant experience from within the pharmaceutical industry or similar large multinational organisation.
  • An extensive knowledge of clinical development/drug development process in various phases of development and therapy areas.
  • A proven ability to learn by working in multiple phases, Tas, and/or different development situation.
  • Experience from leading clinical projects and deliverables, or similar expertise from other areas of drug development.
  • Knowledge of process improvement methodology such as Lean Sigma a desirable, but non-essential, bonus.

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 +44 207 440 0639 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.

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