Tunnell Consulting Inc. Associate Director, Clinical Operations in Austin, Texas

Associate Director, Clinical Operations

Job City: Austin

Job State: US - Texas

Client Project Number: 8744

Description

Experience / Specific Skills:

  • Minimum 5 years industry experience

  • Experience influencing and negotiating at all levels to achieve team delivery

  • Proven experience of all aspects of clinical studies including vendor/CRO management, working as part of a clinical development team and coordinating study level activities to deliver data for filing or publication purposes

  • Experienced in managing global clinical projects, having led the development and implementation of risk management plans, managed study budgets and clinical study resourcing

  • Experience in working within global organizations

  • Strong leadership and motivational skills developed through leading successful global multi-functional matrix study teams through all stages of clinical studies

  • Demonstrated consistent achievement of team delivery against commitments and goals

  • Self-motivated and achievement driven

  • Excellent written and verbal communications skills

  • Phase II and Phase III experience

  • Musculoskeletal

Education:

  • Bachelor degree or equivalent in life sciences

Working Conditions:

  • Strict adherence to regulations

  • Fast paced, dynamic, and fluid environment

  • Laid back professional environment

  • Need to have autonomy

Position Overview:

  • Provides operational direction and leadership to one or more study teams to ensure delivery of all clinical study-related activities to meet study objectives in line with organizational strategic objectives

  • Retains overall accountability for clinical operational aspects of the project within timelines, budget, and quality standards

  • Responsibilities:

  • Working collaboratively within global study teams across multiple time zones

  • Oversee the clinical study protocol development (including amendments) and related documents, in close collaboration with the clinical project lead and other study members

  • Contribute to scientific and clinical operational input for the development of trial- related documents and processes which are led by other line functions (e.g. Case Report Form)

  • In collaboration with the clinical project lead, lead development of protocol level feasibility and provide input into other strategic start-up milestones, such as country and site selection

  • In accordance with the overall program plan, collaborate with Therapeutic Area Project Manager (TAPM) and other line functions to create and manage study specific team goals, milestones, timelines, risk management and quality plans

  • Establish and maintain detailed day-to-day study level timeline plans

  • Oversee the development and active management of the study patient recruitment strategies

  • Ensure study team receives appropriate study specific and therapeutic area training

  • Lead the team in the identification and selection of vendors and participate in the development, management, and tracking of the vendor budget/contract and performance

  • Serve as the primary liaison between client and clinical vendors for clinical studies , such as CROs

  • Accountable for clinical study budgets including forecasting, to ensure efficient expenditure and minimal variance between actual and planned spend

  • In collaboration with the TAPM, conduct study operational team meetings with input into meeting agendas and review of meeting minutes

  • In collaboration with the TAPM, lead external meetings such as project kick-off meetings, Investigator Meetings, etc.

  • Manage Investigational Medicinal Product (IMP) supply plan through collaboration with manufacturing and project management

  • Ensure clinical data are collected and managed in accordance with the study monitoring plan and data quality standards

  • Oversee the safety reporting processes at clinical study sites and ensures reporting timelines are met

  • Monitor compliance within the study team to ICH/GCP and SOPs through maintenance and periodic auditing of training files, and through general team member interactions