Clinical Trials Manager

4 weeks ago

Toronto, Ontario, Canada Allucent Full time
Job Description

We are seeking a highly skilled and experienced Clinical Trials Manager to join our team at Allucent. As a key member of our clinical operations team, you will be responsible for providing leadership and management to our Clinical Research Associates (CRAs) and other clinical functional groups in their day-to-day clinical trial activities.

Key Responsibilities:

  • Coordinating and managing CRA activities across all geographies, liaising with sponsors and project managers to ensure clinical monitoring deliverables are met.
  • Oversight of critical documentation collection, maintenance, and filing.
  • Developing monitoring plans and site monitoring templates and tools.
  • Reviewing trial-specific documents and developing subject-facing materials.
  • Customizing annotated site visit reports according to trial-specific requirements.
  • Selection of investigators and sites, SEV report review and approval.
  • Site initiation management, SIV report review and approval.
  • Monitoring visit report review, management, resolution, and escalation.
  • Managing successful trial close-out, identifying critical activities to make timely and efficient close-out.
  • Responsible for timelines, budget, and quality of clinical monitoring team deliverables.
  • Providing information and input about planned activities and status to project managers and attending project review meetings.
  • Coaching and mentoring CRA team members, including providing performance feedback and assisting in developing and delivering project-specific training.
  • Preparing and chairing CRA calls and actively participating in internal trial team calls and client calls.
  • Overseeing CRA handovers and serving as a site contact for protocol clarifications and subject enrollment.
  • Monitoring and managing trial materials supplies, ensuring investigational product and other trial supplies are shipped to sites.
  • Reviewing data listings and query reports to identify trends and ensuring proactive re-training is conducted with CRAs and site staff.
  • Overseeing the process of protocol deviation and trial non-compliance documentation, tracking, and escalation.
  • Participating in the development of trial newsletters and communication.
  • Requesting appropriate clinical operations staffing, workload, and resources and reporting trial deliverables and resource needs.
  • Assisting project managers in discussions with clients on trial documentation issues or technical-related documentation concerns.
  • Reviewing trial systems updates on a regular basis, ensuring systems reports are up-to-date and reports generated are current and correct.
  • Overseeing eTMF status.
  • Reviewing trial reports and analyzing trends to recognize risks, providing input into mitigation plans, and implementing mitigations belonging to clinical activities.
  • Contributing to the optimization of trial processes to increase efficiency.
  • Coordinating and providing support for trial-related audits and inspections.
  • Contributing to corrective and preventive action plans where needed and ensuring their timely implementation and closure.
  • Ensuring project consistency within and across projects by following Allucent SOPs.
  • Assisting in the preparation of various training materials used by Allucent, including SOPs training and specific trial-related training.
  • Assisting in the preparation and conduct of Kick-Off Meetings, Investigators' meetings, and other committees or trial meetings as requested.
  • Preparing country-level site-facing budgets and managing investigator and site payments as applicable.
  • Supporting project managers in the management of trial vendors as required.
  • Project contract awareness and oversight.
  • Forecasting and reporting on site management units throughout the project life cycle.
  • Identifying changes in scope and liaising with project managers.
  • Managing client expectations related to clinical deliverables in accordance with contracted services and Allucent QMS.
  • Providing input into proposals when required.
  • Actively participating in the preparation, attendance, and presentation of bid defenses or any other presentations to potential clients.
  • Completing routine administrative tasks in a timely manner, including timesheets, travel expense claims, and training.

Requirements:

  • Candidate must be legally authorized to work in the specified country where the job is being advertised.
  • A degree in life sciences or nursing qualification preferred, but not required.
  • A minimum of 5 years of clinical research experience, including a combination of SCRA + CTL/CTM, PM, or regulatory/auditing experience, with at least 1-2+ years of CTL/CTM experience.
  • In-depth knowledge of ICH GCP, clinical trials, and the critical elements for success in clinical trials.
  • Strong therapeutic background.
  • Possesses experience and knowledge in the CRO industry that will support Allucent's management of clinical trials.
  • Strong written and verbal communication skills, including good command of the English language.
  • Professional and strong client-focused.
  • Ability to work in a fast-paced, challenging environment of a growing company.
  • Administrative excellence with attention to detail and accuracy.
  • Leadership and mentoring skills with the ability to mentor and train other CRAs in a positive and effective manner.
  • Excellent team player with team-building skills.
  • Strong organizational skills to be able to manage a full workload across multiple projects.
  • Demonstrates flexibility for creating solutions and process improvement.
  • Analytical, financial, and problem-resolution skills.
  • Proficiency with various computer applications, including Word, Excel, and PowerPoint, CTMS, eTMF.
  • Ability to successfully manage people/project issues.
  • Mature management skills demonstrated by calm and thorough review of situations.
  • Proposes, implements, and evaluates appropriate, creative resolutions.
  • Demonstrates the ability to define and meet project requirements.

Benefits:

  • Comprehensive benefits package per location.
  • Competitive salaries per location.
  • Departmental study/training budget for furthering professional development.
  • Flexible working hours (within reason).
  • Opportunity for remote/hybrid working depending on location.
  • Leadership and mentoring opportunities.
  • Participation in our Buddy Program as a new or existing employee.
  • Internal growth opportunities and career progression.
  • Financially rewarding internal employee referral program.
  • Access to online soft-skills and technical training via GoodHabitz and internal platforms.

  • Clinical Trials Coordinator Lead

    4 days ago

    Toronto, Ontario, Canada Everest Clinical Research Services Inc Full time

    Everest Clinical Research Services Inc, a leading contract research organization (CRO), is seeking an experienced Clinical Trials Coordinator Lead to join our team in Toronto/Markham, Ontario, Canada.Job Summary:As a Clinical Trials Coordinator Lead, you will be responsible for providing exceptional support to clients and internal teams in the delivery of...

  • Statistical Director for Clinical Trials

    5 days ago

    Toronto, Ontario, Canada Everest Clinical Research Services Inc Full time

    Job SummaryWe are seeking a skilled Statistical Director to join our team at Everest Clinical Research Services Inc in Bridgewater, New Jersey. As a key member of our Biostatistics department, you will be responsible for managing clinical trial programs and projects from start to finish.

  • Senior Clinical Trial IWRS Operations Manager

    1 month ago

    Toronto, Ontario, Canada Everest Clinical Research Services Inc Full time

    Job Title: Senior Clinical Trial IWRS MonitorEverest Clinical Research Services Inc is seeking a highly skilled and experienced Senior Clinical Trial IWRS Monitor to join our team. As a key member of our Clinical Trials Technology (CTT) unit, you will be responsible for providing exceptional customer service and support to our clients and internal...

  • Clinical Trial Manager

    2 weeks ago

    Toronto, Ontario, Canada Allucent Full time

    Senior Clinical Trial LeaderAt Allucent, we are dedicated to helping small-medium biopharmaceutical companies navigate the complex world of clinical trials.We are seeking a Senior Clinical Trial Leader to join our team. As a Senior Clinical Trial Leader, you will be responsible for providing leadership, management, and oversight to Clinical Research...

  • Clinical Trials Manager

    4 weeks ago

    Toronto, Ontario, Canada Allucent Full time

    Job DescriptionWe are seeking a highly skilled Clinical Trials Manager to join our team at Allucent. As a key member of our clinical operations team, you will be responsible for providing leadership and management to our Clinical Research Associates (CRAs) and other functional groups in their day-to-day clinical trial activities.Key...

  • Clinical Trials Manager

    4 weeks ago

    Toronto, Ontario, Canada Allucent Full time

    Senior Clinical Trial LeaderWe are seeking a highly skilled and experienced Senior Clinical Trial Leader to join our team at Allucent. As a key member of our clinical operations team, you will be responsible for providing leadership and oversight to our Clinical Research Associates (CRAs) and other clinical functional groups in their day-to-day clinical...

  • Clinical Trials Manager

    4 weeks ago

    Toronto, Ontario, Canada Allucent Full time

    Job DescriptionJob Title: Clinical Trials ManagerJob Summary:We are seeking a highly skilled Clinical Trials Manager to join our team at Allucent. As a Clinical Trials Manager, you will be responsible for providing leadership and management to our clinical research associates and other functional groups in their day-to-day clinical trial activities.Key...

  • Clinical Trials Manager

    4 weeks ago

    Toronto, Ontario, Canada Allucent Full time

    Job DescriptionAt Allucent, we are dedicated to helping small-medium biopharmaceutical companies navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.We are seeking a Senior Clinical Trial Leader to join our team. As a Senior Clinical Trial Leader, you will be responsible for providing...

  • Clinical Trials Manager

    4 weeks ago

    Toronto, Ontario, Canada Allucent Full time

    Job DescriptionWe are seeking a highly skilled Clinical Trials Manager to join our team at Allucent. As a key member of our clinical operations team, you will be responsible for providing leadership and management to our Clinical Research Associates (CRAs) and other functional groups in their day-to-day clinical trial activities.Key...

  • Clinical Trials IWRS Data Management Specialist

    4 days ago

    Toronto, Ontario, Canada Everest Clinical Research Services Inc Full time

    Everest Clinical Research Services IncWe are a full-service contract research organization (CRO) dedicated to providing high-quality clinical research services to the pharmaceutical, biotechnology, and medical device industries worldwide.Job Description:As a Clinical Trials IWRS Data Management Specialist, you will be responsible for ensuring the accuracy...

  • Clinical Trial Operations Manager

    4 weeks ago

    Toronto, Ontario, Canada Allucent Full time

    Job DescriptionWe are seeking a highly skilled and experienced Clinical Trial Operations Manager to join our team at Allucent. As a key member of our clinical operations team, you will be responsible for providing leadership and management to our Clinical Research Associates (CRAs) and other clinical functional groups in their day-to-day clinical trial...

  • Clinical Trials Leader

    2 weeks ago

    Toronto, Ontario, Canada Allucent Full time

    Senior Clinical Trial LeaderWe are seeking a skilled Senior Clinical Trial Leader to join our team at Allucent. As a key member of our clinical operations team, you will be responsible for providing leadership, management, and oversight to Clinical Research Associates (CRAs) and other clinical functional groups.The ideal candidate will possess a strong...

  • Project Manager

    1 month ago

    Toronto, Ontario, Canada Innovaderm Research Full time

    Job DescriptionJob Title: Project Manager - Clinical TrialsJob Summary:We are seeking an experienced Project Manager to lead our clinical trials team. The successful candidate will have a strong background in project management, excellent communication skills, and the ability to work effectively in a fast-paced environment.Key Responsibilities:Lead the...

  • Clinical Research Proposal Manager

    4 weeks ago

    Toronto, Ontario, Canada Everest Clinical Research Services Inc Full time

    Job Title: Clinical Research Proposal ManagerJob Summary:We are seeking a highly skilled Clinical Research Proposal Manager to join our team at Everest Clinical Research Services Inc. As a key member of our proposals and contracts team, you will be responsible for developing and managing proposals for clinical trials, ensuring that they meet the highest...

  • Clinical Trial IWRS Data Integrity Specialist

    2 weeks ago

    Toronto, Ontario, Canada Everest Clinical Research Services Inc Full time

    About the Role:Everest Clinical Research Services Inc seeks a highly skilled Clinical Trials IWRS System Monitor to join our team in Toronto, Ontario, Canada. As a key member of our IWRS/IRT and eDiary team, you will be responsible for providing exceptional support to our clients and ensuring the accuracy and quality of data generated within our CTT...

  • Senior Clinical Data Manager

    4 weeks ago

    Toronto, Ontario, Canada Everest Clinical Research Services Inc Full time

    Everest Clinical Research Services Inc is seeking a skilled Clinical Data Manager to lead data management activities for our clinical trials. The ideal candidate will have a strong understanding of clinical trial data management concepts, processes, and procedures.Key Responsibilities:Develop and maintain Data Management Project Plans.Lead data management...

  • Senior Clinical Data Manager

    4 weeks ago

    Toronto, Ontario, Canada Everest Clinical Research Services Inc Full time

    Everest Clinical Research Services Inc is a leading contract research organization (CRO) providing a wide range of clinical research services to the pharmaceutical, biotechnology, and medical device industries. We serve some of the world's most renowned companies and work with many of the most advanced drugs, biologics, and medical devices in development...

  • Clinical Trials Operations Manager

    2 weeks ago

    Toronto, Ontario, Canada Parexel Full time

    Study Operations Manager II Role OverviewThe Study Operations Manager II plays a pivotal role in the success of our clinical trials, driving operational delivery and ensuring the timely execution of study plans. Reporting to the Global Study Managers, this individual will lead specific aspects of the project, driving countries, executing tasks of moderate...

  • Clinical Trial Operations Lead

    2 weeks ago

    Toronto, Ontario, Canada Allucent Full time

    About the Role:We are seeking a highly skilled Senior Clinical Trial Leader to join our team at Allucent. As a key member of our organization, you will be responsible for providing leadership and management to our clinical research teams, ensuring the successful execution of clinical trials.Key Responsibilities:Lead and manage clinical research teams,...

  • Clinical Trials Proposal Manager

    1 month ago

    Toronto, Ontario, Canada PSI Full time

    Job Title: Clinical Trials Proposal ManagerJob Summary:At PSI, we are seeking a highly skilled Clinical Trials Proposal Manager to join our team. As a key member of our proposal development team, you will be responsible for coordinating all phases of our proposal process, ensuring a win rate of 30% and higher. You will work closely with global teams of...