Senior Clinical Trials Manager

Found in: Jooble CA O C2 - 2 weeks ago

Etobicoke ON, Canada Spectral Medical Inc. Full time

Position: Sr.  Clinical Trials Manager

Site:  Spectral Medical Inc.

Department:  Clinical Operations

Reports to:  VP, Clinical Operations

Hours:  37.5 per week

Status:  Permanent Full-Time

Spectral Medical Inc. is looking for a Senior Clinical Trials Manager who can work on a permanent full-time (hybrid) basis. 

 

Qualifications:

  • 7 plus years’ experience in pharma and/or, biotech clinical research
  • 4 plus years of experience in clinical trial management
  • Experience with FDA regulatory submissions is a preferred skill
  • CCRP or equivalent is an asset
  • Experience in critical care studies and renal studies is an asset
  • Demonstrated success in managing clinical projects from initiation to close out
  • Knowledge of the clinical trial process. Knowledge of ICH guidelines and GCP including basic understanding of regulatory requirements
  • Understanding of the regulatory progression of establishing and maintaining clinical sites
  • Advanced Microsoft Office Word, Excel and Power point programs knowledge and understanding

 

Primary Responsibilities:

a. Management of trials and oversight of day-to-day trial operations (60%)

  • Participate in the design and development of trial protocols, amendments and associated plans, manuals, CRFs and relevant trial materials
  • Track project progress and timelines and its adherence to the project plan
  • Oversight and management of day-to-day trial operations including CRO management
  • Oversight and management of certain sub-studies that may be undertaken from time to time
  • Participate in the evaluation of potential clinical study sites and management of site start-up, close-out and maintenance activities, and scheduling of monitoring visits in accordance with data collection timelines
  • Coordinate site trainings, shipment of study supplies, and review of regulatory documents for the release of investigational products to site
  • Development and maintenance of enrollment plans including tracking enrollment, identifying trends, and implementing action plans to address issues in collaboration with study teams
  • Track study budgets, reconcile payments, and escalate any issues to ensure accurate and timely payments to trial sites and vendors in line with contracts
  • Oversee study monitoring including reviewing finalized monitoring reports generated by CRO to track site level activities and identify issues, trends, etc
  • Creation and revision of SOPs as required

 

b. Study Reports preparation and review (25%)

  • Preparation and review of semi-annual progress reports/annual reports for the FDA and quarterly reports for the DSMB in conjunction with the CRO
  • Preparation and/or review of study reports for clinical sites (Newsletters, Enrollment Reports etc)
  • Preparation and review of regulatory submissions related to assigned clinical trials (this includes FDA communications, FDA Clinical Study Reports, PMA related submissions, etc)

 

c. Management of Study Team Members (15%)

  • Oversee study team members performance and training, delegate tasks and support their roles as necessary

WHAT WE OFFER:

  • Great learning and growth opportunities
  • Hybrid remote work flexibility
  • A competitive compensation package
  • Full Benefits Package

 

 

About Spectral Medical Inc

At Spectral Medical, we are pioneering a transformative theragnostic approach that will enable improved outcomes for patients with  endotoxic septic shock (ESS). ESS  is a life-threatening condition that arises when the body’s response to infection spirals into a storm of systemic inflammation. It’s characterized by a dangerous drop in blood pressure and a cascade of multiple organ failure caused by the presence of a bacterial toxin, known as endotoxin.

 

Spectral is a Phase 3 company seeking U.S. FDA approval for its unique product for the treatment of patients with endotoxic septic shock, Polymyxin B hemoadsorption (“PMX”). PMX is a therapeutic hemoadsorption device that removes endotoxin from the bloodstream and is guided by the Company’s Endotoxin Activity Assay (EAA™), the only FDA-cleared diagnostic for endotoxin in the bloodstream.

 

EAA™ and PMX are both Health Canada licensed and commercially available in Canada. In July 2022, the U.S.  FDA granted Breakthrough Device Designation  for PMX for the treatment of endotoxic septic shock.

 

Spectral strives to exceed the highest ethical, financial and scientific standards in all our operations and activities. By maintaining excellent relationships within the clinical community, as well as with customers and business partners. Leading with precision and innovation, Spectral is unwavering in the fight against endotoxic septic shock and is committed to reducing mortality from this deadly disease.

Spectral is listed on the Toronto Stock Exchange under the symbol EDT.

Spectral Medical Inc values the diversity of people and actively encourage women, indigenous peoples, members of visible minorities, people with disabilities, and LGBTQ2+ persons to apply. We thank all applicants in advance, however, only those selected for an interview will be contacted.

  • Clinical Trial Investigator

    Found in: Jooble CA O C2 - 1 week ago

    Kingston, ON, Canada American Society of Clinical Oncology (ASCO) Full time

    The Canadian Cancer Trials Group (CCTG) is a cooperative oncology group that designs and administers clinical trials in cancer therapy, supportive care, and prevention across Canada and internationally. We support a collaborative network of researchers, physicians, scientists, and statisticians internationally recognized for finding the treatments that give...

  • Canadian Cancer Trials Group

    Found in: Jooble CA O C2 - 1 week ago

    Kingston, ON, Canada American Society of Clinical Oncology (ASCO) Full time

    The Canadian Cancer Trials Group (CCTG) is a cooperative oncology group that designs and administers clinical trials in cancer therapy, supportive care, and prevention across Canada and internationally. We support a collaborative network of researchers, physicians, scientists, and statisticians internationally recognized for finding the treatments that give...

  • Senior Project Manager

    Found in: Jooble CA O C2 - 7 days ago

    Toronto, ON, Canada Worldwide Clinical Trials Full time

    Requisition Number: 7779 Position Title: Associate Director, Project Management External Description: Who we are Worldwide Clinical Trials (Worldwide), a leading global contract research organization (CRO), works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications – from discovery...

  • Senior Project Manager

    Found in: Jooble CA O C2 - 1 week ago

    Toronto, ON, Canada Worldwide Clinical Trials Full time

    Requisition Number: 7804 Employment Type: Regular Who we are: Worldwide Clinical Trials (Worldwide), a leading global contract research organization (CRO), works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications – from discovery to reality. Anchored in our company’s scientific...

  • Senior Project Manager

    Found in: Jooble CA O C2 - 7 days ago

    Toronto, ON, Canada Worldwide Clinical Trials Full time

    Requisition Number: 7686 Employment Type: Regular Who we are Worldwide Clinical Trials (Worldwide), a leading global contract research organization (CRO), works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications – from discovery to reality. Anchored in our company’s scientific...

  • Senior Project Manager

    Found in: Jooble CA O C2 - 2 days ago

    Toronto, ON, Canada Worldwide Clinical Trials Full time

    Requisition Number: 7779 Employment Type: Regular Who we are Worldwide Clinical Trials (Worldwide), a leading global contract research organization (CRO), works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications – from discovery to reality. Anchored in our company’s scientific...

  • Clinical Trials Specialist

    Found in: Jooble CA O C2 - 1 week ago

    Toronto, ON, Canada Ozmosis Research Inc. Full time

    Job Title: Clinical Trials SpecialistHours: 35 HRS/week; 9:00-5:00, Monday-FridayStatus: Full TimeLevel: Minimum 2 Years ExperienceLocation: Toronto, ONPosition: Combination in-office and remote positionOzmosis promotes a strong team environment and is seeking a new valued member of our team. If you have experience in oncology, clinical trials management,...

  • Clinical Trials Specialist

    Found in: Jooble CA C2 - 7 days ago

    Toronto, ON, Canada Ozmosis Research Inc. Full time

    Job Title: Clinical Trials SpecialistHours: 35 HRS/week; 9:00-5:00, Monday-FridayStatus: Full TimeLevel: Minimum 2 Years ExperienceLocation: Toronto, ONPosition: Combination in-office and remote positionOzmosis promotes a strong team environment and is seeking a new valued member of our team. If you have experience in oncology, clinical trials management,...

  • Associate Director

    Found in: Jooble CA O C2 - 2 weeks ago

    Toronto, ON, Canada Worldwide Clinical Trials Full time

    Requisition Number: 7803 Position Title: Associate Director, Project Management External Description: Who we are Worldwide Clinical Trials (Worldwide), a leading global contract research organization (CRO), works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications – from discovery...

  • Clinical Trials Specialist

    Found in: Jooble CA O C2 - 1 week ago

    Toronto, ON, Canada Ozmosis Research Inc. Full time

    Job Title: Clinical Trials Specialist Hours: 35 HRS/week; 9:00-5:00, Monday-Friday Status: Full Time Level: Minimum 2 Years Experience Location: Toronto, ON Position: Combination in-office and remote position Ozmosis promotes a strong team environment and is seeking a new valued member of our team. If you have experience in oncology, clinical...

  • Clinical Trials Specialist

    Found in: Adzuna CA C2 - 16 hours ago

    Toronto, ON, C6A, Ontario, Canada Ozmosis Research Inc. Full time

    Job Title: Clinical Trials SpecialistHours: 35 HRS/week; 9:00-5:00, Monday-FridayStatus: Full TimeLevel: Minimum 2 Years ExperienceLocation: Toronto, ONPosition: Combination in-office and remote positionOzmosis promotes a strong team environment and is seeking a new valued member of our team. If you have experience in oncology, clinical trials management,...

  • Associate Director, Project Management

    Found in: Jooble CA O C2 - 1 week ago

    Toronto, ON, Canada Worldwide Clinical Trials Full time

    Requisition Number: 7706 Employment Type: Regular Who we are: Worldwide Clinical Trials (Worldwide), a leading global contract research organization (CRO), works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications – from discovery to reality. Anchored in our company’s scientific...

  • Associate Director, Clinical Trial Transparency

    Found in: Jooble CA O C2 - 2 days ago

    Mississauga, ON, Canada AstraZeneca GmbH Full time

    This is what you will do: The Associate Director, Clinical Trial Transparency serves as a subject matter expert and advisor on global transparency needs. This role will ensure that all clinical study registrations and information are accurately routed, tracked, and entered in appropriate databases as per regulatory requirements and in line with Alexion...

  • Clinical Trial Administrator

    Found in: Jooble CA O C2 - 15 hours ago

    Toronto, ON, Canada Psi CRO Ag Full time

    PSI is a leading Contract Research Organization with more than 28years in the industry,offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications. Job Description Study Administration Ensures that the project team is timely...

  • Clinical Research Coordinator

    7 days ago

    Etobicoke, Canada Centricity Research Full time

    Aventiv Research, IACT Health, LMC Manna Research, and True North Clinical Research have united to become the largest network of fully-owned and integrated clinical research sites in North America, Centricity Research. The sites that were formerly known as Aventiv operate in Ohio and Arizona and specialize in phase 1 pharmaceutical, device, and diagnostic...

  • Senior Global Development Scientist Director

    Found in: Jooble CA O C2 - 1 week ago

    Mississauga, ON, Canada AstraZeneca Full time

    Job Title: Senior Global Development Scientist Director Locations: In Office in one of these locations - Boston Seaport, Warsaw PO, Barcelona SP or Mississauga CA As a Senior Global Development Scientist Director (SGDSD) you will independently provide scientific and clinical input to all aspects of late stage product development. This includes but is...

  • Senior Scientist, Bioinformatics, Oncology

    Found in: Jooble CA O C2 - 2 weeks ago

    Mississauga, ON, Canada AstraZeneca GmbH Full time

    AstraZeneca is a global, science-led, patient-focused biopharmaceutical company. It is dedicated to discovering, developing, and delivering innovative, meaningful medicines and healthcare solutions for some of the world’s most serious diseases. At AstraZeneca Oncology, we are leading a revolution to redefine cancer care by pushing the boundaries of science...

  • Clinic Manager

    4 days ago

    Etobicoke, Canada 3D Lifestyle Full time

    We are looking for a service oriented, enthusiastic, sales driven and professional Medical Aesthetician to join our Toronto team as a Clinic Manager. *Hourly wage + commission and bonuses applicable **Qualifications and Requirements**: - Medical Aesthetician Certificate. - Outstanding interpersonal communication skills. - Excellent writing and oral...

  • Manager, Business Performance

    Found in: Jooble CA O C2 - 2 weeks ago

    Markham, ON, Canada Sienna Senior Living Full time

    We are Sienna Senior Living, a publicly traded company (TSX:SIA) and one of Canada’s leading owners and operators of seniors’ residences. We offer care, support, services and housing in Retirement and Long Term Care to seniors/residents and their families. And we truly believe it is a privilege to serve Canada’s seniors, ensuring they live fulfilling...

  • Senior Scientist, Bioinformatics, Oncology R&D

    Found in: Jooble CA O C2 - 2 weeks ago

    Mississauga, ON, Canada AstraZeneca GmbH Full time

    AstraZeneca is a global, science-led, patient-focused biopharmaceutical company. It is dedicated to discovering, developing, and delivering innovative, meaningful medicines and healthcare solutions for some of the world’s most serious diseases. At AstraZeneca Oncology, we are leading a revolution to redefine cancer care by pushing the boundaries of...