Associate Director Clinical Operations

22 April 2020
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Description

For one of our clients, a global innovator in liver therapeutics, TRIUM is looking for an Associate Director Clinical Operations.

Function

As an Associate Director Clinical Operations, you are responsible for the overall coordination of the clinical team and monitoring of daily activities to ensure the successful completion of clinical trials. S/he participates in the planning, implementation, monitoring and management of clinical trials in compliance with applicable regulations, ICH–GCP Guidelines and SOPs. Additionally, s/he supports overall management of the department in collaboration with senior management.

MAIN RESPONSIBILITIES:

  • Interacts with applicable vendors to ensure that contractual obligations related to clinical activities are met
  • Provide support to, the CSM and CRA to ensure the timely initiation and completion of clinical trials
  • Conducts daily, ongoing communication responding to inquiries from clinical team members and clinical sites; as applicable
  • Participates in initial clinical development meeting identifying clinical study objectives
  • Ensures clinical study team resources are continuously adequate; participates in the interview and selection of clinical personnel for studies
  • Participates in the coordination and conduct of study specific training, as appropriate; ensures standards for monitoring and reporting are met
  • Participates in the coordination and conduct clinical team meetings to monitor study progress and share best practice; includes the development of meeting agendas and minutes
  • Ensures project-related clinical data is tracked and maintained in an existing database, i.e. CTMS, EDMS, study oversight file, etc.; provides reports as applicable
  • Ensures fully executed contracts are in place (client, sites, providers), as applicable
  • Contributes to the management of the clinical budget and out of scope documentation throughout the duration of the project
  • Contributes to the development of training programs to ensure opportunities for employee development and advancement
  • Mentors and trains personnel in clinical study monitoring and management and the relevant applicable regulations, ICH-GCP Guidelines; ensures standards for monitoring and reporting are met
  • Responsible for completing employee appraisals, as required; communicates with superior and HR to review salary and recommend promotion (horizontal or vertical)
  • Assists in resolution of Clinical Operations personnel performance issues; including termination as necessary
  • Assesses employees and provides on-going feedback and recommendations for development
  • Effectively manages workload of supervised staff, with continual assessment and adjustment as necessary
  • Manages employee time off requests, timesheets and expense report approvals
  • Contributes to the management and reporting of Key Performance Indicators (KPIs)
  • Responsible for identifying the need for additional clinical employees in the department; participates in the interview process and works with HR in the final decision on candidates
  • Assists in the development, modification and execution of company policies that affect immediate operations and may also have company-wide effect
  • Works on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors
  • Contributes to the development and revision of clinical SOPs and department guidelines to ensure adherence to applicable ethical, regulatory and clinical standards
  • Develops, or supports the development of, clinical study documents, templates, plans, manuals and tracking tools
  • Participates in the coordination and conduct of clinical department meetings; includes the development of meeting agendas
  • Participates in the analysis and development of the Clinical Operations department budget
  • Contributes to the planning and conduct of feasibility studies
  • Provides oversight for regulatory submissions, as applicable
  • Participates in audits as required; oversees follow-up activities and ensures timely implementation and completion of corrective action plans in close cooperation with QA, as appropriate
  • Performs other duties as assigned by upper management

Profile

QUALIFICATIONS / SKILLS:

  • Bachelor’s degree in a life science or related field of study or equivalent combination of studies, nursing qualifications, and/or work experience
  • 10+ year’s relevant experience in clinical operations
  • Considerable depth of experience in clinical study management, monitoring, and in developing study-related documents
  • In-depth knowledge of ICH-GCP guidelines and applicable regulations
  • Intermediate proficiency in Microsoft Word, Excel, Outlook, Internet Explorer, Power Point and MS Project
  • Effective verbal and writing skills
  • Fluent in English

Interested in this job?

Send us your CV and motivation to: staffing@triumclinicalconsulting.com