Associate Director Research Clinical Trials Operations

Pailin Group Executive Search

Associate Director Research Clinical Trials Operations

St. Louis Area

Job description

Our premier client applications and nominations for the position of Associate Director Research Clinical Trials Operations.

The Department of Neurology, seeks an experienced clinical research administrator to play a key role in managing a pioneering clinical trials infrastructure studying changes in people who carry an Alzheimer’s disease mutation.

The Dominantly Inherited Alzheimer’s Network-Therapeutic Trials Unit (DIAN-TTU) is an international network, established by the National Institute on Aging of the National Institutes of Health, that brings together 11 research centers to conduct the first ever clinical trial testing of experimental drug therapies within a global network of individuals who have a rare form of Alzheimer’s disease, but have not yet experienced the onset of symptoms.

The Associate Director Research Clinical Trials Operations is responsible for the operational planning and execution of multiple Phase II – III global/international studies from protocol concept through the clinical study report.

These responsibilities include, but are not limited to:

  • Collaboration with all relevant groups (Trial Sponsors, Trial Project Leaders, Administrative Operations, Cores/Components, CRO/ADCS, performance sites) to develop and manage clinical project timelines.
  • Disseminating clinical project communication to all functional groups as appropriate.
  • Contributing to protocol synopsis development and Clinical Operations feasibility assessments.
  • Writing study protocols, amendments and administrative changes based on approved protocol synopsis.
  • Participating in the selection and oversight of CRO and clinical vendors/components (biomarkers, imaging, and data management).
  • Planning and participation in investigator meetings in collaboration with all cross-functional team members.
  • Ensuring the training of Trial Project Leaders, performance sites and Cores/Components on the protocol and expectations of the study.
  • Collaborating with Administrative Operations, Project Leaders, CRO, and/or vendors for resolution of corrective actions as a result of QA audit and/or regulatory inspections.
  • Collaborating with Sponsors to ensure appropriate and timely drug supply for assigned studies.

Qualified candidates will have a bachelor's degree or RN with a minimum of 10 to 15 years of experience in clinical research including at least one year of industry experience in a sponsor role with significant leadership and management experience.

Well qualified professionals please forward CV/Resumes and include compensation and interview availability to Debra Hartmann - Division Group Manager

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