This job posting has expired.

Team Manager

April 24 2017
Industries Pharmaceutical, Biotechnology
Categories Bioanalysis, Chemistry, Clinical data - Statistics - Biostatistics, Clinical research
Laval, QC

Algorithme Pharma, a company belonging to the Altasciences group, is a private Canadian organization that specializes in clinical research (CRO). We conduct over 200 clinical trials annually in Phase I/IIa, Bioequivalence and Bioanalysis with the participation of over 5,000 participants. In other words, we conduct trials for new drugs or new combinations of drugs, new devices, or new ways to use existing treatments. Our team is made up of close to 500 professionals from the medical and scientific fields who work together to achieve a common goal: to contribute to the advancement of pharmaceutical science.

The Team Manager, Bioanalysis (BPI) will be assigned as Bioanalytical Principal Investigator for designated clinical studies and responsible to ensure the overall integrity of all biostudy/validation data as it pertains to different regulatory requirements and GLPs.

Main Responsibilities:

  • Act as Bioanalytical Principal Investigator for designated clinical studies by serving as the primary study  contact for Study Directors/clients for bioanalytical clinical production/validation projects;
  • Compiles and communicates study requirements to appropriate study team members;
  • Ensures the overall integrity of all biostudy/validation data as it pertains to SOPs, GLPs, GCPs and regulatory requirements;
  • Monitors progress and status of assigned studies. Ensures that all experimental data, including observations of unanticipated responses are accurately recorded and verified;
  • Works with Analysts and the study team to troubleshoot and resolve assay problems and other study issues as they arise, if necessary;
  • To manage and coordinate teams of technical people (e.g. Analysts, QC Auditors, Assistant Team Managers) for assigned biostudies and method validations to assure on-time delivery of high quality data and reports;
  • Review and provide comments and recommendations for the bioanalytical portions of clinical protocols as required;
  • Develops validation plans and Bioplans to support scope of clinical protocol;
  • To conduct/oversee mid-level scheduling of validations and biostudies;
  • Organize and communicate complex data sets in a clear and concise manner to key stakeholders from diverse backgrounds;
  • To review or approve SOP/Protocol deviations and QA reports;
  • To sign method SOP revisions;
  • To perform Interdepartmental and sponsor interactions as needed;
  • Conducts individual and team meetings with staff;
  • To coordinate technical training  for their employees (Analysts, QC Auditors);
  • To attend departmental and interdepartmental meetings;
  • Keep up to date with respect to pertinent regulatory developments in the industry, to new SOPs, procedures, and techniques via training sessions, team meetings and internal communication avenues;
  • To conduct all work in compliance with applicable SOPs, GCPs, GLPs, and observe all company guidelines and policies as required;
  • To perform any other duties as required.

Qualifications:

  • College degree and/or University degree in Chemistry, Biology, or equivalent field.
  • A minimum of 3 years of experience in scientific field and in management ideally in medical and/or pharmaceutical fields is required or equivalent experience;
  • In-depth knowledge of OECD, EMA, FDA-GLP and TPD regulations, and general SOPs, is also required;
  • Excellent scientific knowledge, a strong team player and an excellent ability to interpret data, troubleshoot and suggest next steps;
  • Good management skills, excellent communication (both written and verbal in French & English) and interpersonal skills;
  • Strong leadership, highly developed decision making with excellent sense of urgency and ability for solving complex analytical problems, excellent flexibility.

Working conditions:

  • Evening Shift
  • 35 hours/week
  • Flexible schedule, between 10:00 a.m to 8:00 p.m

We offer comprehensive training to all our employees, a dynamic work environment that fosters teamwork and above all, a job where you can develop your career.

By providing your application to Algorithme Pharma, an Altasciences Company, you hereby consent to Algorithme Pharma obtaining personal information that is related to the position for which you applied.  You also consent to Algorithme Pharma transferring your application details to our recruitment partners for their review and assistance. You also consent to Algorithme Pharma keeping your application on file. Algorithme Pharma is an equal opportunity employer – referring to the Employment Equity Act of Canada. The information on this site is for information purpose only and is not intended to be relied upon with legal consequence.

If your application meets the qualifications of this position, a member of the Human Resources department will call you. Please note that only candidates selected for an interview will be contacted

Here are some similar positions.

Jobs.ca network