Clinical Research Manager

1 week ago

Québec, Quebec, Canada Parexel Full time

Position Purpose:
The Clinical Research Manager (CRM) is responsible for the following:

  • Primarily accountable for end-to-end performance and project management for assigned protocols in a country in compliance with International Committee on Harmonization (ICH) / Good Clinical Practice (GCP) and country regulations, Client policies and procedures, quality standards and adverse event reporting requirements internally and externally.
  • For certain studies, could be responsible for several countries in a cluster.

Organizational Relationships:

  • Reports to Parexelassigned Line Management with daytoday direction from Client. Refer to Organizational Chart for details regarding assigned role and associated reporting structure.
  • Collaborates internally with (Headquarters) HQ functions, regional and local operations, European Union (EU) Clinical development, Pharmacovigilance, Global Medical Affairs (GMA) to align on key issues/decisions across the trials. Global Human Health (GHH) to be consulted as needed.

Primary Responsibilities:

  • Main Point of Contact (POC) for assigned protocols and link between Country Operations (CO) and clinical trial team (CTT).
  • Responsible for project management of the assigned studies: o Proactively plans/drives/tracks execution and performance of deliverables/timelines/results to meet country commitments from feasibility and site selection, recruitment, execution and close out.
  • Accountable for performance for assigned protocols in country in compliance with International Committee on Harmonization (ICH) /Good Clinical Practice (GCP) and country regulations, Client policies and procedures, quality standards and adverse event reporting requirements internally and externally o Performs quality control visits as required.
  • Reviews Monitoring Visits Reports (MVRs) and escalates performance issues and training needs to CRA manager and /or functional vendor and internal management as needed.
  • Leads local study teams to high performance:
  • Trains in the protocol for other local roles.
  • Collaborates with and supports Clinical Research Associates (CRAs) as protocol expert.
  • Coordinates activities across the different local country roles ensuring a strong collaboration (including the Clinical Trial Coordinator (CTC), CRAs, and Clinical Operations Manager (COM).
  • Responsible for creating and executing a local risk management plan for assigned studies.
  • Ensures compliance with Clinical Trial Management System (CTMS), electronic Trial Master File (eTMF) and other key systems in assigned studies.
  • Escalates as needed different challenges and issues to Therapeutic Area (TA)
Director / Clinical Research Director (CRD) / Clinical Quality Management (CQM) and or Clinical Trial team (CTT)

Identifies and shares best practices across clinical trials, countries, clusters.

  • Responsible for collaboration with functional outsourcing vendors, investigators, other external partners in assigned studies.
  • Country POC for programmatically outsourced trials for assigned protocols.
  • As a customerfacing role, this position will build business relationships and represent Client with investigators.
  • Serves local business needs as applicable in his/her country (if delegated can sign contracts and manage budgets).
  • Supports local and regional strategy development consistent with longterm corporate needs in conjunction with Clinical Research Director (CRD), Therapeutic Area Head (TAH) and Regional Operations.
  • Lead and contribute to initiatives and projects adding value to the business and supporting the strategy.
  • Completes training assigned by Client and/or EP, as necessary, including general training requirements, SOPs, and system and process related training.
  • Adheres to EP and Client SOPs and processes.

Education and Certification:

  • Bachelor's degree in science (or comparable) required; advanced degree (Master's degree, MD, PhD) preferred
  • Skills and Experience:
  • 56 years of experience in clinical research; CRA experience preferred.
  • Knowledge in Project Management/Site Management with proven strong project management skills and /or project management certification or relevant training program/close mentoring.
  • Strong organizational skills with demonstrated success required.
  • Requires ability to make decisions independently while overseeing important activities relevant to clinical research in the country according to predetermined global policies and commitments with the support, oversight, and supervision of the Therapeutic Area (TA) or Country Research Director (CRD).
  • Requires strong understanding of the local regulatory environment.
  • Strong scientific and clinical research knowledge is required with strong understanding of clinical trial planning, management, and metrics as well as the ability to focus on multiple deliverables and protocols simultaneously.
  • Experience functioning as a key link between Country Operations and Clinical Trial Teams.
  • Communicates ef

  • Clinical Research Manager

    1 week ago

    Québec, Quebec, Canada Labcorp Full time

    Clinical Research ManagerHome-Based in Montreal, QuebecWhy settle for one thing when you can have everything?Labcorp Drug Development gives you the best two-for-one opportunity for career growth. Who doesn't want twice the perks? Working at one of the largest FSP CROs—and partnering with one sponsor with a dedicated therapeutic focus. You can have it...

  • Clinical Research Manager- FSP

    1 month ago

    Québec, Quebec, Canada Parexel Full time

    Parexel FSP is looking for a Clinical Research ManagerJob Purpose:The Clinical Research Manager (CRM) is responsible for the following:• Primarily accountable for end-to-end performance and project management for assigned protocols in a country in compliance with International Council for Harmonization (ICH) / Good Clinical Practice (GCP) and country...

  • Clinical Research Manager- FSP

    4 weeks ago

    Québec, Quebec, Canada Parexel Full time

    Parexel FSP is looking for a Clinical Research ManagerJob Purpose:The Clinical Research Manager (CRM) is responsible for the following:• Primarily accountable for end-to-end performance and project management for assigned protocols in a country in compliance with International Council for Harmonization (ICH) / Good Clinical Practice (GCP) and country...

  • Bilingual Clinical Research Associate

    3 weeks ago

    Québec, Quebec, Canada Parexel Full time

    Working with heartAt the end of the day we're all patients. Because of this, the Parexel team takes our work personally and does it with empathy and heart. When our values align, there's no limit to what we can achieve. Our clinical operating model drives effectiveness, reduces handoffs and increases employee, client and site satisfaction. As a Clinical...

  • Bilingual Clinical Research Associate

    1 month ago

    Québec, Quebec, Canada Parexel Full time

    Working with heartAt the end of the day we're all patients. Because of this, the Parexel team takes our work personally and does it with empathy and heart. When our values align, there's no limit to what we can achieve. Our clinical operating model drives effectiveness, reduces handoffs and increases employee, client and site satisfaction. As a Clinical...

  • Clinical Research Nurse

    1 week ago

    Québec, Quebec, Canada Syneos Health Full time

    Illingworth Research Group offers patient-focused clinical services to various industries such as pharmaceuticals, healthcare, biotechnology, and medical devices. These services include mobile research nursing, patient concierge, medical photography, and clinical research. The company is known for its expertise in all study phases and a wide range of...

  • Physician

    1 week ago

    Québec, Quebec, Canada Syneos Health Clinical Full time

    DescriptionPhysician - Contractor - CanadaSyneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help our...

  • Clinical Research Coordinator

    1 week ago

    Québec, Quebec, Canada Centre universitaire de santé McGill Full time

    Organization descriptionLe Centre universitaire de santé McGill (CUSM) est un centre hospitalier universitaire intégré, reconnu à l'échelle internationale pour l'excellence de ses programmes cliniques, de sa recherche et de son enseignement. Le CUSM a pour objectif d'assurer aux patients des soins fondés sur les connaissances les plus avancées dans le...

  • Research Assistant I

    1 week ago

    Québec, Quebec, Canada Syneos Health Clinical Full time

    **Description****Research Assistant I**Venez découvrir ce que nos employés savent déjà : le travail accompli ici a des répercussions partout. Nous sommes un chef de file de l'industrie biopharmaceutique en constante évolution, ce qui signifie que vous aurez d'innombrables occasions de travailler avec des experts du monde entier et vous obtiendrez la...

  • Clinical Operations Leader

    1 week ago

    Québec, Quebec, Canada Parexel Full time

    Clinical Operations Leader / Clinical Trial Manager team members at Parexel average close to 10 years with the company and we are expanding our team.We currently have Home Based Clinical Operations Leader/Clinical Trial Manager positions available in Canada.As the Clinical Liaison to the Project Leader, the COL/CTM leads the clinical aspect of the trial and...

  • Sample Management Specialist I

    1 week ago

    Québec, Quebec, Canada Syneos Health Clinical Full time

    DescriptionSample Management Specialist ISyneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.Our Clinical Development model brings the customer and the patient to the...

  • Research Assistant 2

    1 week ago

    Québec, Quebec, Canada McGill University Full time

    Please refer to thejob aid for instructions on how to apply.Position Summary:The Research Assistant 2 assists the Research Supervisor in conducting research projects and as required, is responsible for the functional supervision of the Research Assistant 1 and/or Undergraduate/Graduate Research Assistant. The Research Assistant 2 will be primarily involved...

  • Student Research Assistant

    1 week ago

    Québec, Quebec, Canada McGill University Full time

    Please refer to thejob aid for instructions on how to apply.This is a chronic pain-focused quality improvement (QI) project funded by the Reseau-1 (via FRQS) and McGill PBRN (primary care-based research network). The NPI is Dr. Kudrina, and the co-PI is Dr. Grad; both PI-s are family medicine clinician-researchers. Dr. Kudrina specializes in chronic pain and...

  • Communication and Content Marketing Manager

    1 week ago

    Québec, Quebec, Canada Provalis Research Full time

    COMMUNICATION AND CONTENT MARKETING MANAGERFull-time or part timeProvalis Research offers a stimulating, collaborative environment with rewarding opportunities for career advancement. We value excellence and provide our employees with the support they need to achieve their highest levels of competence.Scope of workWe are seeking a driven, detail-oriented...

  • Observational Research Specialist II

    3 weeks ago

    Québec, Quebec, Canada Parexel Full time

    As an Observational Research Specialist II, you will independently provide site management and support activities for Observational/ Non-interventional research study sites in accordance with relevant Standard Operating Procedures (SOPs), study-specific procedures and regulations.Key Accountabilities:Depending on study assignment and with support as...

  • Observational Research Specialist II

    1 month ago

    Québec, Quebec, Canada Parexel Full time

    As an Observational Research Specialist II, you will independently provide site management and support activities for Observational/ Non-interventional research study sites in accordance with relevant Standard Operating Procedures (SOPs), study-specific procedures and regulations.Key Accountabilities:Depending on study assignment and with support as...

  • Scientist, Translational Research

    1 week ago

    Québec, Quebec, Canada 35Pharma Inc. Full time

    35Phama is a biopharmaceutical company that designs and develops innovative therapeutics for life threatening lung diseases and musculoskeletal disorders. We believe in connecting rigorous science with our innate sense of urgency to rapidly generate breakthrough therapies for patients in need to better quality of life. Our highly qualified team of drug...

  • Registered Dietitian

    1 week ago

    Québec, Quebec, Canada PCM TRIALS - Quality Mobile Research Full time

    SummaryThe Registered Dietitian is a per diem/PRN position for PCM Trials. A PCM Trials RD will provide nutritional services defined in a clinical trial virtually or in-person for clinical trial participants.Perform the full scope of Registered Dietitian practices; including, but not limited to, providing virtual lifestyle counseling visits to improve...

  • Research Associate, Preclinical Development

    1 week ago

    Québec, Quebec, Canada 35Pharma Inc. Full time

    5Phama is a biopharmaceutical company that designs and develops innovative therapeutics for life threatening lung diseases and musculoskeletal disorders. We believe in connecting rigorous science with our innate sense of urgency to rapidly generate breakthrough therapies for patients in need to better quality of life. Our highly qualified team of drug...

  • Assistant(E) de Recherche

    1 week ago

    Québec, Quebec, Canada Centricity Research Full time

    Aventiv Research, IACT Health, LMC Manna Research et True North Clinical Research se sont unis pour devenir le plus grand réseau de sites de recherche clinique entièrement détenus et intégrés en Amérique du Nord, Recherche Centricité. Le nom Recherche Centricité, souligne également le fait que notre organisation a acquis une position importante et...