Clinical Trial Manager (CTM)

March 29 2019
Categories Pharma, Biotech, Sciences, R&D, Clinical data - Statistics - Biostatistics, Laboratory, Clinical research
Laval, QC

Under the direction of the Senior Director of Clinical and Regulatory Affairs, the Clinical Trial Manager (CTM) assists the clinical research/drug development members at Bellus Health in the management of all aspects of Clinical Trial activities for the assigned project(s). The CTM, in concert with the clinical research/drug development Directors and VP, is accountable for achieving successful delivery of Bellus Health clinical team activities at the project level by meeting company and regulatory requirements according to time, quality/scope and budget constraints.

Essential Duties and Responsibilities:

To perform this job successfully, an individual must be able to perform the following:

  • In concert with the clinical research/ drug development Directors, the CTM proactively manages project level operational aspects of Clinical Trial(s) including management of trial timeline, budget, resources and vendors.
  • Provide efficient updates on trial progress to the Clinical Team and/or upper management, with respect to vendor selection, project plans, trial budget and timeline management, quality standards and risk mitigation.
  • Lead sponsor study startup process, including but not limited to conduct of the Trial Kick-off meeting, the set-up of trial master file (TMF), site selection, Investigators meeting, study plans and finalization of site and vendor Clinical Trial Agreements and budgets.
  • Maintain electronic and paper project files to include regulatory filings contracts, confidentiality disclosure agreements, manufacturing records, all research-related documentation, SOPs, budgets, meeting related agendas and minutes, etc.
  • Ensure effective project plans are in place and operational for each trial and work proactively with the Clinical Team and CROs to set priorities in accordance with applicable project plans, company /CROs standard operational procedures (SOPs), ICH/GCP guidelines and regulatory requirements.
  • Supervise the monitoring activities related to clinical studies managed by CROs; ensure tracking, follow up and resolution of site issues have been completed in a timely manner.
  • Conduct co-monitoring visits to research centers in the company of monitors (CRAs) and reviews monitoring reports issued by the CRAs.
  • Contribute to the audit plan and assist auditors during audits if necessary.
  • Ensure potential study risks are escalated to the attention of the Clinical Team and/or management when appropriate.
  • Monitor the quality of vendor deliverables, address quality issues with the appropriate team members and identify opportunities to improve training, execution and quality control across the clinical team.
  • Contribute to the review and approval of vendor invoices in collaboration with the Accounting team and ensure investigator payments occur in a timely manner.
  • Review and approve vendor responses to quality assurance audits for appropriateness, timeliness and accordance with company SOPs and regulatory requirements.
  • Ensure all study documentation is filed in the TMF in accordance with company SOPs/all regulatory requirements and provide oversight to the clinical team regarding TMF filing, maintenance and archival procedures.
  • Contributes to the writing and review of protocols and amendments, study plans and other clinical research documents (eg, Investigator Brochure, study report) and to the regulatory submissions.
  • Provide support to the internal team.​

Qualifications:

To perform this job successfully, an individual must be able to perform each essential duty.

The requirements listed below are representative of the knowledge, skill, and/or ability required.

Education/Experience:
The ideal candidate will offer:

  • Bachelor's degree in Life Sciences or related fields or equivalent work experience, at minimum.
  • Four or more years of clinical operations experience for, in the Pharmaceutical, Biotechnology or CRO industry is required. Field experience as a CRA is an important asset.
  • Experience in early phase trials (Phase I-II) and First-In-Man trials is an asset.

Knowledge, Skills and Abilities:

  • Bilingual (syntax, grammar and spelling in French and English).
  • Excellent verbal and written communication skills.
  • Must have a thorough knowledge of clinical research concepts, practices, and FDA/EU regulations and ICH Guidelines regarding drug development phases, clinical research and data management methods.
  • Proficient in the use of the Microsoft Office suite of products, including Word, Excel, PowerPoint and Outlook and the Internet.
  • Willingness and ability to travel domestically and internationally are required.

Required Skills

  • Teamwork.
  • Management of priorities.
  • Good analytical and synthesis capacity.
  • Sense of organization and responsibility.
  • Meticulous attention to detail and highly organized.
  • Experience in developing project timelines and task lists.
  • Excellent interpersonal skills and ability to work cohesively in team settings.
  • Communication skills.
  • Mobility.
  • Discretion, reliability, autonomy.
  • Leadership.
  • Able to work independently to plan and accomplish goals.
  • Methodical mind.
  • Initiative and creativity.
  • Excellent analytical skills.
  • Strong computer skills to include word processing, spreadsheets, presentation software, graphics software, project management software, e-mail, database and internet applications.

Please submit your resume via this website.

Apply now!

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