Clinical Monitoring Operations Manager
7 days ago
About 35Pharma
At 35Pharma, we're a clinical-stage biopharmaceutical company dedicated to designing and developing innovative therapeutics for life-threatening lung diseases, musculoskeletal, and metabolic disorders. Our mission is to rapidly generate breakthrough therapies for patients in need, enhancing their quality of life.
We have a highly qualified team of drug developers and company builders with a track record of advancing complex biologics from discovery through clinical trials. Our R&D facilities are located in the heart of Montréal, Canada, comprising laboratory space for pre-clinical research and manufacturing development that support our mission.
About the Role
We're seeking an experienced Clinical Monitoring Operations Manager to oversee monitoring activities at clinical sites, ensuring compliance with clinical protocols, study procedures, regulations, and industry standards. As a key member of our clinical operations team, you will be responsible for conducting on-site and remote monitoring visits, reviewing essential documents, and serving as the primary point of contact with sites for protocol-related matters.
Key Responsibilities:
- Primary Point of Contact: Act as the main liaison between clinical sites and our organization for study protocol conduct.
- Site Support: Collaborate with sites on patient recruitment initiatives and develop site-specific recruitment plans.
- Monitoring Visits: Conduct on-site and remote monitoring visits, including site qualification, initiation, interim, and close-out visits.
- Documentation: Prepare or review confirmation and follow-up letters to investigators and monitoring visit reports.
- Study Documents: Participate in the preparation and review of study documents, such as clinical protocols, informed consent forms, laboratory manuals, and pharmacy manuals.
- Investigator Meetings: Assist in planning and conducting investigator meetings.
- Essential Document Management: Ensure review, collection, and tracking of sites' essential documents, reconciling them with the trial master file.
- Cross-Functional Collaboration: Work closely with contract research organizations (CROs) and other vendors as necessary.
- Performance Escalation: Escalate findings related to clinical monitoring or site management issues.
- CORrection Actions: Implement corrective actions and training related to clinical monitoring activities.
- CRA Oversight: Manage CRAs, evaluate performance, set objectives, and provide continuous training.
- Travel: Travel up to 30% of the time for on-site monitoring visits or co-monitoring visits with CROs or independent CRAs.
Qualifications:
- Bachelor's Degree: Health sciences, nursing degree, or equivalent experience.
- Clinical Experience: Minimum 2 years' experience in a pharmaceutical or biotechnology company or CRO as a clinical research associate conducting on-site monitoring visits.
- Leadership Experience: Minimum 3 years' experience in a senior CRA, clinical trial management, or project management role in phase 1-3 multicenter clinical trials.
- Communication Skills: Excellent written and verbal communication skills in English (and French), as well as strong presentation skills to meet diverse audience needs.
- Relationship Building: Ability to build effective relationships with site personnel, CRO staff, vendors, and colleagues.
- Problem-Solving: Superior problem-solving, deductive reasoning, and decision-making skills.
- Time Management: Excellent time management and organizational skills, prioritizing tasks efficiently to achieve set goals.
- Detailed Record Keeping: Attention to detail, maintaining accurate records, and proficiency in required software and clinical trial systems.
- Regulatory Knowledge: Excellent understanding of regulatory requirements and good clinical practices.
- Ethical Standards: Demonstrate the highest ethical standards, promoting trust, respect, and integrity.
- Computer Skills: Proficiency in Word, Excel, PowerPoint, clinical trial systems, and computer skills.
- Availability: Willingness to travel to clinical sites.
Salary:$120,000 - $150,000 per year
-
Canada Advanced Clinical Full timeJob OverviewWe are seeking an experienced Regulatory Affairs Manager to join our team at Advanced Clinical. This part-time position will be based in Canada and will play a crucial role in developing and implementing global regulatory strategies for contracted clinical programs.About UsAdvanced Clinical is a clinical development and strategic resourcing...
-
Regulatory Affairs Leadership Position
3 days ago
Canada Advanced Clinical Full timeAbout Advanced ClinicalAdvanced Clinical is a clinical development and strategic resourcing organization dedicated to delivering exceptional services across the drug development journey.We are committed to improving the lives of all those touched by clinical research, approaching each opportunity with foresight, character, resilience, and innovation. Our...
-
Canada 35Pharma Full timeAbout the RoleWe are seeking an experienced Clinical Operations Manager to join our team at 35Pharma, a clinical-stage biopharmaceutical company dedicated to developing innovative therapeutics for life-threatening lung diseases and musculoskeletal and metabolic disorders.The successful candidate will be responsible for overseeing clinical monitoring...
-
Clinical Trials Operations Manager
6 days ago
Canada Parexel Full timeParexel is seeking an experienced Clinical Trials Operations Manager to lead Local Study Teams in Canada. This role requires a strong understanding of cell therapy and its applications.The successful candidate will have at least 3 years of experience in Development Operations or related fields, with a good knowledge of international guidelines ICH GCP and...
-
Regulatory Affairs Strategist
6 days ago
Canada Advanced Clinical Full timeJob DescriptionWe are seeking an experienced Regulatory Affairs Strategist to join our team at Advanced Clinical.About UsAt Advanced Clinical, we are a clinical development and strategic resourcing organization dedicated to providing exceptional services across the drug development journey. Our goal is to improve lives by approaching each opportunity with...
-
Regulatory Affairs Manager
6 days ago
Canada Advanced Clinical Full timeAdvanced Clinical is a clinical development and strategic resourcing organization committed to providing a better clinical experience across the drug development journey. Our goal is to improve the lives of all those touched by clinical research – approaching each opportunity with foresight, character, resilience and innovation. Based on decades of...
-
Regulatory Affairs Manager
6 days ago
Canada, CA Advanced Clinical Part timeAdvanced Clinical is a clinical development and strategic resourcing organization committed to providing a better clinical experience across the drug development journey. Our goal is to improve the lives of all those touched by clinical research – approaching each opportunity with foresight, character, resilience and innovation. Based on decades of...
-
Regulatory Affairs Manager
5 days ago
Canada Advanced Clinical Full timeAdvanced Clinical is a clinical development and strategic resourcing organization committed to providing a better clinical experience across the drug development journey. Our goal is to improve the lives of all those touched by clinical research – approaching each opportunity with foresight, character, resilience and innovation. Based on decades of...
-
Regulatory Affairs Manager
6 days ago
Canada Advanced Clinical Full timeAdvanced Clinical is a clinical development and strategic resourcing organization committed to providing a better clinical experience across the drug development journey. Our goal is to improve the lives of all those touched by clinical research – approaching each opportunity with foresight, character, resilience and innovation. Based on decades of...
-
Regulatory Affairs Director
4 days ago
Canada Advanced Clinical Full timeJob DescriptionWe are seeking a highly skilled Regulatory Affairs Manager to join our team at Advanced Clinical.About the RoleThis is a part-time position based in Canada, and as a Regulatory Affairs Manager, you will be responsible for partnering with cross-functional teams to develop and implement global regulatory strategies.You will work closely with...
-
Clinical Project Manager
6 months ago
Canada Dalcor Pharma Full time**Position Summary**: The Clinical Project Manager (CPM) is responsible for the management of all aspects of Clinical Trial activities for assigned project(s). The CPM is accountable for achieving successful delivery of clinical team activities at the project level by meeting company and regulatory requirements according to time, quality/scope and budget...
-
Clinical Project Manager
2 weeks ago
Canada Tigermed Full timeThis is a mixed role of project management and study site supervision. **Job Purpose:**The primary responsibility of this position is to manage projects from site selection to initiation, monitoring, and close-out of assigned clinical studies in accordance with Tigermed Standard Operating Procedures (SOPs), International Conference on Harmonization Good...
-
Site Monitor/CRA
1 month ago
Canada, CA Parexel Full timeThe Site Monitor will be responsible for data integrity, data quality and ensuring compliance with ICH GCP and local requirements at the site level. Monitoring will be conducted in line with the Study Monitoring Plan and will be performed virtually for the majority of activities to supplement on-site visit requirements. The Site Monitor will collaborate with...
-
Clinical Monitoring Team Lead
1 week ago
Canada 35Pharma Full timeAbout 35Pharma35Pharma is a clinical-stage biopharmaceutical company committed to developing innovative therapeutics for life-threatening lung diseases, musculoskeletal, and metabolic disorders. Our mission is to rapidly generate breakthrough therapies for patients in need, improving their quality of life.We operate from our R&D facilities located in the...
-
Clinical Project Manager and Site Supervisor
3 days ago
Canada Tigermed Full timeJob SummaryWe are seeking a highly skilled Clinical Project Manager and Site Supervisor to join our team at Tigermed. As a key member of our clinical operations department, you will be responsible for project management and study site management from site selection to initiation until monitoring and close-out of assigned clinical studies.About the...
-
Clinical Trial Operations Specialist
19 hours ago
Canada Parexel Full timeJob SummaryWe are seeking a skilled Clinical Trial Operations Specialist to join our team at Parexel. This role is responsible for the delivery of clinical studies at allocated sites, ensuring compliance with international guidelines and local regulations.Key Responsibilities:Site Management: Contribute to the selection of potential investigators, conduct...
-
Senior Clinical Project Manager
18 hours ago
Canada Tigermed Full timeAbout the Role:We are seeking a highly experienced Senior Clinical Project Manager to join our team at Tigermed. This is an exciting opportunity to work on a mixed role of CRA and Project Supervisor, overseeing project management and study site management from site selection to initiation until monitoring and close-out of assigned clinical studies.Key...
-
IT Infrastructure Manager
19 hours ago
Canada Manager – IT Full timeJob TitleManager – IT Infrastructure - Bilingual (English and French)About the JobWe are seeking a highly skilled and experienced IT Infrastructure Manager to join our team in Ottawa, Ontario. As a key member of our technology department, you will be responsible for managing and maintaining our IT infrastructure, ensuring seamless operations and efficient...
-
Senior Clinical Study Manager
4 days ago
Canada Parexel Full timeJob Overview:">Parexel is seeking a skilled Senior Clinical Study Manager to lead Local Study Teams in Canada. Experience with cell therapy is highly desirable.">The Senior Clinical Study Manager will oversee the delivery of committed components of clinical studies according to agreed resources, budget, and timelines while adhering to Client Procedural...
-
Clinical Project Manager
6 months ago
Canada Caidya Full time**Job Title**:Project Manager **Job Location**: Remote - United States or Canada **Special Requirements**:This position will be assisting sponsors in China. - Must be able to communicate in Chinese (Conversational level or higher) - Must be flexible to work outside of normal business hours in order to support clients in China **Job Overview**: The Project...
