Job Title:

Associate Director of Clinical Operations

Company:

ethica CRO Inc.

Location:

Montreal, QC

Closing Date:

2017-10-31


We are a full-service Contract Research Organization (CRO) that conducts and manages ethical clinical research on behalf of sponsors within the international pharmaceutical, biotechnology, medical device, nutraceutical, and cosmeceutical industries.

We are currently looking for highly-skilled and motivated Associate Director, Clinical Operations to join our dynamic and growing team.  The Associate Director, Clinical Operations provides support and manages all clinical, data management and statistical activities of the company.  Working closely with the Managing Director, the incumbent is responsible for the accurate and efficient management of clinical studies and the implementation of good data management and statistical practices in compliance with ethica CRO’s accredited SOPs and existing regulations and guidelines.

This is primarily an in-house position requiring minimal travel (up to 10%).

Responsibilities and activities of the Associate Director, Clinical Operations include, but are not limited to, the following:

  • Coordinate and prioritize the activities of the company under the direction of the Managing Director.
  • Oversee day-to-day operations of clinical, data management, and biostatistics activities.
  • Assist with establishing project resource requirements prior to project initiation and throughout the management of a project.
  • Assist with establishing performance standards for all activities and review output to ensure standards are consistently met
  • Assist in determining work processes, resource allocation, operational plans and/or schedules in order to achieve company objectives and to ensure integrity of timelines.
  • Provide support and coaching to company staff in areas of training, disciplinary action, problem resolution, planning, and work assignment delegation.
  • Identify and lead process improvement activities for the company.
  • Assist with developing and reviewing clinical study protocols, ICFs, CSRs and other reports.
  • Review outcomes of audits and manage corrective action plans.
  • Conduct SAS double-programming to confirm validity of statistical output.
  • Develop/review data management/biostatistical documentation as per study protocol and applicable SOPs (eg, statistical analysis plans, data management plans, statistical reports, etc.).

To qualify for this opportunity, you must possess the following:

  • MSc or PhD in a clinical research related discipline (e.g., medical science, biostatistics, etc.)
  • At least 10 years of clinical research and data management/statistical experience, particularly with medical devices
  • Strong biostatistical and SAS programming skills
  • Personnel management experience
  • Thorough knowledge of ICH-GCP Guidelines

Must be able to effectively interact with professionals in a variety of fields (e.g., medicine, regulatory affairs as well as legal and marketing).

Salary will commensurate with experience and ability. Only those candidates who fulfill all job criteria will be contacted for an interview.

TO APPLY:

If you have the skills and experience required for this position, please forward your resume to:

E-mail: info@ethicacro.com



Posted 2017-08-04



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