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Associate Director of Clinical Research Job

Eingestellt von Yoh

Gesuchte Skills: Opal, Client


ASSOCIATE DIRECTOR OF CLINICAL RESEARCH needed for a contract opportunity with Yoh's client located in Gaithersburg, MD.

What You'll Be Doing:
- Responsible for 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 (eg 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 (eg CRO/ARO) partners for externally managed/outsourced studies as appropriate
- Responsible for ensuring timely compliance with companywide governance controls (eg 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

What You Need to Bring to the Table:
- Bachelors in medical or biological sciences or discipline associated with clinical research is required. Advanced degree is preferred.
- Clinical Project Management experience is required
- Seven to ten (7 - 10) years of clinical experience is required 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.


RECRUITER: Krista Leach






  • Einsatzort:

    Gaithersburg, Vereinigte Staaten

  • Projektbeginn:


  • Projektdauer:

    Keine Angabe

  • Vertragsart:


  • Berufserfahrung:

    Keine Angabe

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