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Project Leader, Clinical Affairs

March 7 2018
Industries Pharmaceutical, Biotechnology
Categories Project Management, Business Analysis, Pharma, Biotech, Sciences, R&D, Pharma - Biotech, Scientific and Regulatory affairs, Clinical data - Statistics - Biostatistics, Project management, Pharmacovigilance, Research and development, Clinical research, Pharmacology
Laval, QC

Prometic Biosciences Inc. develops unique innovative therapeutics, orally active compounds that target multiple uncovered medical needs in the fields of hematology, oncology, nephrology, fibrosis and autoimmune diseases.


The department of Clinical Affairs of Prometic Biosciences Inc. is seeking a Project Leader, Clinical Affairs, to work with its team at Laval, Quebec.  Under the supervision of the Manager, Clinical Operations, the incumbent will oversee clinical research efforts performed in house or by contract research organizations (both in and outside of Canada) while working with cross-functional multidisciplinary study teams on clinical trial strategy, design and execution. This individual will work on multiple trials in Phases 1 through 3 and develop strong relationships with key opinion leaders and investigators. This position is responsible for oversight of clinical trials, including any activities necessary to assure investigational sites of ongoing multi-center clinical studies are in compliance, and are being conducted according to Good Clinical Practices (GCPs), protocols and all ethical and appropriate regulatory requirements.


The mandate of the Senior Project Leader, Clinical Affairs, will be mainly to:


  • Participate in the development of Study Protocols, Investigator Brochures, Clinical Development Plans and other key study documents in conjunction with other team members and with minimal guidance.
  • Participate in the preparation of regulatory documents in support of regulatory submissions, including clinical section of IND's and CTA's, license applications, IND safety reports and annual reports for assigned trials, responses to regulatory authorities and Ethics Committees/IRBs, as well as other documents, as appropriate.
  • Participate in the vendors/supplier's selection.
  • Provide scientific and clinical input to study-related documents and analysis plans including study management plan, monitoring plan, Informed consent forms (ICF), pharmacy and/or lab manuals, case report forms (CRF)/data management plans, statistical analysis plans (SAP), clinical pharmacology analysis plans and clinical study reports (CSR).
  • Coordinate the functional team members to ensure the project deliverables (timelines, quality, and productivity) are met.
  • Manage study start-up activities in conjunction with other team members.
  • Monitor study timelines, patient recruitment, retention and data cleaning to ensure successful outcome of the project.
  • Oversee clinical trial study monitoring activities by CRO or Prometic personnel, and may include:
    • Ensuring regulatory and protocol compliance of investigator/investigative sites;
    • Coordinating sponsor's communications with sites to ensure investigators' responsibilities;
    • Overseeing site selection & qualification of investigators and sites;
    • Reviewing and approving of monitoring reports to ensure consistency across sites, and to minimize problems such as protocol deviations;
    • Reviewing and providing input into patient recruitment plan and retention plan;
    • Assisting with drug shipment to clinical sites as defined per project;
    • Conducting prequalification, site initiation, interim monitoring and closeout visits as required, and/or co-monitoring with clinical research associates;
    • Preparing correspondence and study documentation with appropriate archival of electronic and paper copies;
    • Assisting in negotiating grants/budgets with investigators and vendors, and preparing contracts;
    • Organizing investigator meetings.
  • Develop, review, understand and comply with Clinical Research SOPs.
  • Ensure consistency, accuracy and compliance of clinical data.
  • Direct preparation of Annual Reports and safety summaries for inclusion into protocol and Investigator Brochures updates.


The selected candidate must preferably hold a MS in Life Sciences or BS/B.A./RN (Life Sciences or Nursing), combined with a minimum of five (5) years of experience leading clinical trials across functional groups. They should also have prior onsite monitoring experience in the pharmaceutical, biotechnology, or biologics industries and/or at a CRO and extensive knowledge of GCPs.


The following criteria are required as well:


  • Superior interpersonal, organizational and problem-solving skills;
  • Strong written and verbal communication skills.
  • Ability to work collaboratively in a fast-paced, team-based matrix environment and to function independently as appropriate.
  • Proven ability to efficiently manage multiple projects and tight timelines.
  • Ability to be assertive while utilizing good people skills to motivate CRO and site personnel.
  • Ability to effectively prioritize all aspects of clinical trials being managed.
  • Willingness to learn and accept new job tasks as defined by each project.
  • Good computer skills in Microsoft Office programs with emphasis on Word and Excel; ability to use SharePoint also desirable.


Prometic offers a competitive compensation, comprehensive benefits program, a flexible work schedule and a casual working environment.


To apply, please send a cover letter and copy of your resume to **@********.com with the following reference: PBI-MED-1801. Prometic is an equal opportunity employer. Only chosen candidates will be contacted for an interview.  For more information about Prometic, visit our website

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