Clinical Operations Lead

4 weeks ago

London Ontario KZ, Middlesex, Canada Alimentiv Inc Full time

Responsible for the clinical operations of a project within a defined regional/global level. Provides oversight of project deliverables, assigned Clinical Research Associate (CRAs) and Investigator sites in accordance with the Monitoring Plan, Protocol, Good Clinical Practice (GCP), ICH guidelines and local regulations. The COL acts as a primary liaison between the CRAs and the clinical project team. Additional responsibilities include project specific training of CRAs, conducting assessment visits with CRAs, implementation of enrollment and recruitment strategies, preparation of the monitoring plan and other structural documentation and the oversight of monitoring visit scheduling, site and monitoring performance metrics, issue escalation and corrective actions. The COL will develop study tools for site and CRA use, review visit reports, review and track protocol deviations, and support other objectives for clinical operations and the clinical project team.

Project Oversight
  • Overall oversight of (a group of) regional CRAs to ensure (site) compliance with study protocol, study plans, ICH-GCP, local regulations and study timelines.
  • Monitoring support visits (Co-monitoring), per project requirements, to aid the site/CRA in the satisfactory performance and compliance with standards mentioned above.
  • May support clinical project team by providing oversight of study deliverables related to other departments (e.g. Data Management, TMF Operations, etc.)
  • Oversee regional startup and feasibility activities.
  • Assist in vendor management activities as required per project.
  • Perform review of visit reports for quality, compliance and appropriate site management.
  • Assure compliance with high quality and timely project deliverables according to the project requirements and the monitoring plan.
  • Proactive management of site and country performance (recruitment, data collection, document collection, TMF review etc.) and inform clinical project team on progress.
  • Contribute to financial project management processes as applicable. May include but may not be limited to input on revenue recognition, site payments, and site pass-through expense review.
  • May be required to manage/oversee investigator sites including CRA responsibilities, on a temporary or permanent basis.
Project Liaison
  • Conduct regular global CRA calls with the monitoring and site management team, as well as individual/country CRA calls
  • Attend meetings with Study Sponsor to provide status updates on country and site progress
  • Provide operational support and guidance to the monitoring team throughout project.
  • Provide project training/mentoring to regional CRAs on study procedures, clinical plans and guidelines, and timelines for the study. Ensures study specific training requirements are completed and documented.
  • First point of contact for regional CRAs for study-specific questions and issues. Escalates to PM and other functions as appropriate.
  • Support line managers by providing status updates on utilization and performance of CRAs.
  • Liaise with line manager for assigning sites to CRAs following line manager allocation of a CRA resource to the project.
  • Conduct CRA Assessment visits per departmental requirements to assess the performance of the CRA against their monitoring responsibilities.
Study Documents and Plans
  • Develop training materials and study tools for sites and CRAs, including monitoring plans.
  • Develop and implement enrolment and recruitment strategies together with clinical project team.
  • Develop presentation materials for and presents at Sponsor Kickoff meetings, Investigator meetings and Sponsor Calls (as needed), and prepares presentations for Site Qualification Visits and Site Initiation Visits.
Qualifications
  • College diploma/degree AND 7-9 years related experience +continuous training and knowledge/skills upgrading
OR
  • Undergraduate university degree (Bachelors or Honors Bachelors) AND 4-6 years' experience + substantial on-going job-related training
Other
  • Health Sciences, Life Sciences or Nursing specialty preferred, or SoCRA and/or ACRP Certification/Designation.
  • Should have a minimum of 3 years CRA experience, have strong experience with EDC systems, be proficient with MS Office, have strong written and verbal communication skills and highly effective interpersonal and organizational skills.
  • Demonstrate the following attributes: proactive, detail oriented, task-driven and highly organized.
  • Demonstrate the critical elements of GCPs and local regulations as they relate to clinical monitoring, IRB/EC and Investigator responsibilities.
  • Demonstrated ability in report writing and strong ability to critically understand clinical research documents.
  • Ability to handle multiple tasks to meet deadlines in a dynamic environment.
Working Conditions
  • Home-based
#J-18808-Ljbffr

  • Clinical Director

    3 weeks ago

    London, Ontario, K5Z, Middlesex, Canada Pillar Nonprofit Network Full time

    Recognized throughout Southwestern Ontario as a leader in children’s (birth-14 years) mental health, Vanier Children’s Mental Wellness provides innovative treatment programs and services for children experiencing emotional and behavioural challenges. As a registered charity and not-for-profit agency, Vanier has been in operation for over 54 years and is...

  • Manager of Clinical Services

    4 weeks ago

    London, Ontario, K5Z, Middlesex, Canada CBI Health Full time

    Manager of Clinical Services – London Fanshawe, Ontario CBI Health is Canada’s leading community healthcare provider, and our passionate team is at the heart of what we do. Every day, our 13,000 staff make a meaningful difference in our clients’ lives as we live the core values that define us: heart, respect, reliability, teamwork and innovation. Join...

  • Clinical Specialist

    4 weeks ago

    London, Ontario, K5Z, Middlesex, Canada St-Amour Full time

    Job DescriptionJoin our client, a leading medical distributor specializing in innovative interventional radiology and cardiology products, as a sales representative. You will be responsible for managing your territory as your own business. You will have sales targets to meet, and your role involves product demonstrations and training sessions. This role...

  • Clinical Administrative Assistant

    4 weeks ago

    London, Ontario, K5Z, Middlesex, Canada Gambit Clinic Full time

    Qualified Candidates from London, ON and nearby areas ONLY or Willing to Relocate to LONDON, Ontario. About Gambit Clinic Gambit Clinic is a pioneer in the digital health industry, providing accessible, high-quality healthcare to patients across Canada. Through our innovative telehealth platform, we connect patients with a network of dedicated health...

  • Imaging Operations Manager

    4 weeks ago

    London, Ontario, K5Z, Middlesex, Canada Healthcare Businesswomen’s Association Full time

    Job Description SummaryWhen we put our heads together, we can do brilliant work. And when we do brilliant work, we can achieve remarkable things for patients as we positively transform healthcare. We are looking for Imaging Operations Managers to join our existing global team.Job DescriptionThis role will report to the Vendor Alliance Lead. The Imaging...

  • Operations (Ops) Team Lead

    4 weeks ago

    London, Ontario, K5Z, Middlesex, Canada TSMG Holding Full time

    The Operations (Ops) Team Lead role assists in overseeing day-to-day operations, providing guidance and management where needed to the Drivers. The Ops Lead reports to the Country Manager.Primary Responsibilities:Manage team of Data Collection Driving Operations field resourcesDrive day-to-day operations following standard operating proceduresAssist in...

  • operations supervisor

    4 weeks ago

    London, Ontario, K5Z, Middlesex, Canada Northwest London Veterinary Clinic Full time

    EducationBachelor's degreeTasksPrepare and submit reportsEnsure smooth operation of equipmentCo-ordinate, assign and review workRequisition or order materials, equipment and suppliesArrange for maintenance and repair workCo-ordinate activities with other work units or departmentsConsult with clients after sale to provide ongoing supportEstablish work...

  • Store Lead

    4 weeks ago

    London, Ontario, K5Z, Middlesex, Canada Tailored Brands Full time

    Reports to Store Manager: As a Store Lead, you are expected to partner with your Store Manager (SM) to provide support in assisting the store team members to achieve sales performance expectations through active coaching, development of a team selling environment, and operational excellence when you are the manager on duty. This position is assigned store...

  • Team Lead

    3 weeks ago

    London, Ontario, K5Z, Middlesex, Canada Healthy Planet Full time

    We’re looking for a dynamic Team Lead Health Consultant who embodies awesomeness and knows how to lead by example. You bring a strong background in retail sales, leadership, and a passion for natural wellness to the team.Our dynamic and talented Team Lead Health Consultants leverage their leadership skills, retail sales background, and passion for natural...

  • Store Lead

    4 weeks ago

    London, Ontario, K5Z, Middlesex, Canada Moores Clothing Full time

    Reports To Store ManagerAs a Store Lead, you are expected to partner with your Store Manager (SM) to provide support in assisting the store team members to achieve sales performance expectations through active coaching, development of a team selling environment, and operational excellence when you are the manager on duty. This position is assigned store keys...

  • Team Lead

    1 month ago

    London, Ontario, K5Z, Middlesex, Canada Accoravillage Full time

    WHAT WE’RE LOOKING FOR?The Team Lead links the leadership team and the sales associates by assisting in the operational functions of the store, and motivating the team to exceed goals. Reporting directly to the Store Manager, the Team Lead provides support and coverage to the Store and Assistant Managers in their absence. They model desired selling and...

  • Process Lead FOS

    4 weeks ago

    London, Ontario, K5Z, Middlesex, Canada Ingredion Full time

    TITLE: Process Lead – FOS LOCATION: London, Ontario REPORTS TO: Operations Manager Primary Function: Responsible for managing operations of the FOS Process at the London Facility and to lead in EHS&S, food safety, quality, productivity, profitability, and efficiency through the implementation of strong leadership, effective processes and procedures, and...

  • Interim Lead

    4 weeks ago

    London, Ontario, K5Z, Middlesex, Canada Sephora USA, Inc Part time

    Job ID: 253784Store Name/Number: ON-Westwood Power Centre (1554)Address: 3099 Wonderland Rd S Unit #1, London, ON N6L 1R4, Canada (CA)Full Time/Part Time: Full TimePosition Type: RegularYou’ll love working here…As a Team Lead, you will be assigned a World such as Client Experience, Beauty Services, or Operations or a combination of these Worlds. You are...

  • Multi-Unit Practice Manager- Southwood Dental

    1 month ago

    London, Ontario, K5Z, Middlesex, Canada Dental Corp Full time

    Multi-Unit Practice Manager- Southwood DentalAbout us: Southwood Dental Studio has built an excellent reputation within London and the surrounding communities. We are known for our friendly, family-oriented, professional practice with doctors and staff who truly care about our patients’ health and well-being. We serve the areas of Colonel Talbot,...

  • Pharmacy Manager

    4 weeks ago

    London, Ontario, K5Z, Middlesex, Canada Lmc Full time

    LMC Pharmacy is a consultation-based pharmacy specializing in diabetes training, education and comprehensive medication assessments. We are co-located in LMC Healthcare clinics, Canada’s largest specialist care provider in diabetes, endocrinology & metabolism. LMC Pharmacists work collaboratively with the endocrinologists and clinic team to deliver patient...

  • Team Lead

    4 weeks ago

    London, Ontario, K5Z, Middlesex, Canada Dynacare Full time

    Laboratory Team Lead We are currently looking to hire a Team Lead - Health Services in London, Ontario. This is a Permanent Full-Time (benefit eligible) opportunity. Reporting to the LHSC Manager, you will be responsible for reviewing day to day operations of the LHSC location(s) which include location workflow, client services and overseeing occupational...

  • Manager, Maintenance

    4 weeks ago

    London, Ontario, K5Z, Middlesex, Canada Victoria Hospital Full time

    Who We Are London Health Sciences Centre (LHSC) is a world-class academic health sciences centre located in the southwestern Ontario city of London. Just two hours from Toronto and two hours from Detroit, London features a beautiful and walkable downtown core located on the Thames River, a vibrant culinary scene and scores of activities that highlight local...

  • VP, IT Operations

    4 weeks ago

    London, Ontario, K5Z, Middlesex, Canada McCormick & Company Full time

    You may know McCormick as a leader in herbs, spices, seasonings, and condiments – and we’re only getting started. At McCormick, we’re always looking for new people to bring their unique flavor to our team.McCormick employees – all 14,000 of us across the world – are what makes this company a great place to work.We are looking to hire a VP, IT...

  • Project Manager, Solution Operations

    4 weeks ago

    London, Ontario, K5Z, Middlesex, Canada BDO Canada Full time

    Putting people first, every dayBDO is a firm built on a foundation of positive relationships with our people and our clients. Each day, our professionals provide exceptional service, helping clients with advice and insight they can trust. In turn, we offer an award-winning environment that fosters a people-first culture with a high priority on your personal...

  • FT - Operations Supervisor

    4 weeks ago

    London, Ontario, K5Z, Middlesex, Canada Yurek Specialties Limited Full time

    Yurek Specialties Limited is a state-of-the-art processing facility in London, ON, which features the latest equipment to support the processing, production, and delivery of medical supplies and infusion equipment, along with related supplies, to the Elgin, Norfolk, Oxford, London-Middlesex, Huron, Perth, Grey, Bruce and Grand River counties. We are...