Clinical Trial Manager I

4 days ago

Winnipeg, Canada Syneos Health Full time

Description

Clinical Trial Manager

Syneos 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 customers achieve their objectives.

Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.

Discover what our 29,000 employees, across 110 countries already know:
WORK HERE MATTERS EVERYWHERE

Why Syneos Health

We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we’re able to create a place where everyone feels like they belong.

Job responsibilities
- Responsible for site management oversight, clinical monitoring and central monitoring deliverables with a focus on patient safety, protocol/GCP/regulatory compliance and data integrity.
- Oversees site interactions post activation through site closeout. This may include patient recruitment, investigator payments or other related activities.
- May be responsible for identification of critical data and process, protocol execution risks and risk mitigations related to completion of the Risk Assessment and Categorization Tool (RACT).
- Reviews the study scope of work, budget and protocol content and ensures the clinical project team (CRAs/Central Monitors) is aware of the contractual obligations and parameters.
- Uses prior clinical experience, operational data, metrics and reports to identify risks to clinical trial management deliverables.
- Escalates to the project manager any risks to clinical trial management deliverables (timeline, quality and budget) and any activities and requests which are out of contracted scope.
- Employs strategic thinking and problem-solving skills to propose and implement risk mitigations.
- Participates and presents in key meetings such as Kick Off Meeting.
- Serves as an escalation point for communications with investigator site staff and may be required to interact on the phone or in person with principal investigators or other site staff members. This may include accompanying CRA team members to sites for observation or conflict resolution.
- Collaborates with other functional leaders such as Study Start Up, Patient Recruitment and Data Management to coordinate delivery handoffs and meet expected study milestones such as site activation targets, enrollment targets and database lock timelines. Reviews and provides feedback on other functional plans (e.g. Data Management Plan, Communication Plan) as they relate to the clinical trial management activities.
- Responsible for development and ongoing maintenance of clinical study tools and templates, including the Clinical Monitoring Plan. Ensures CTMS, dashboards and other systems are set up and available for use by the clinical team, including overseeing user acceptance testing (UAT) as needed. Ensures access and audit trail reviews are conducted as required.
- Coordinates initial and ongoing training to the study team regarding protocol specificities, Case Report Form (CRF) completion, dashboards, Sponsor Standard Operating Procedures (SOPs), clinical plans and guidelines, data plans and timelines for the study.
- Oversees resourcing allocations for CRAs and Central Monitors, site assignments and study team members' conduct, and identifies risks to delivery or quality.
- Ensures quality of the clinical monitoring, central monitoring and site management deliverables within a project and maintain proper visibility of its progress by the use of approved systems and / or tracking tools.
- Reviews the project oversight dashboards and other clinical trial systems (e.g. Clinical Trial Management System (CTMS), Electronic Data Capture (EDC), eDiary, Electronic Patient Reported Outcomes (ePROs),Trial Master File (TMF), IVRS/IWRS, Central Monitoring dashboards), to oversee site

  • Research Coordinator

    4 weeks ago

    Winnipeg, Canada Chronic Disease Innovation Centre Full time

    **Job Title**: Research Coordinator - Clinical Trials **Reports to**:Research Manager **Position Summary**: The Research Coordinator will be responsible for the administration of clinical trials and/or prospective research studies. The scope of duties includes study initiation activities including obtaining ethical and institutional approvals, study budget...

  • Clinical Dietitian I

    7 months ago

    Winnipeg, Canada Aramark Full time

    The Clinical Dietitian I provides overall nutrition care to patients and is considered an entry-level role. Assures that the nutritional needs of the individual patients are being met and that all documentation as it relates to the patient’s nutritional status is complete and accurate. Plans and administers activities related to resident/patient nutrition...

  • Clinical Research Assistant

    2 months ago

    Winnipeg, Canada Beijing Medical Centre Full time

    **Job Summary** **Duties** - Assist in the preparation and organization of clinical trial documents and materials. - Conduct literature reviews and summarize findings relevant to ongoing research projects. - Collect, record, and maintain data from clinical trials using various software tools. - Collaborate with research staff to ensure compliance with...

  • Pediatric Oncologist-hematologist with Interest in

    3 months ago

    Winnipeg, Canada C17 Full time

    Pediatric Oncologist-Hematologist **PEDIATRIC ONCOLOGIST-HEMATOLOGIST WITH **I**NTE**R**EST **I**N PEDIATR**I**C NEURO-ONCOLOGY**- The Department of Pediatric Oncology and Hematology, CancerCare Manitoba consists of eight faculty members with active clinical and research programs in pediatric oncology, neuro-oncology, blood and marrow transplant,...

  • Bookkeeper

    7 months ago

    Winnipeg, Canada Aqua i Laser Full time

    Are you passionate about accounting? Do you thrive in busy environments and like taking on new challenges? We are looking for a **Full-Time Accountant/Bookkeeper** to join our dynamic work environment alongside bright and passionate team of staff and doctors! Aqua i Laser has been proudly serving Winnipeg with eye care services since 2018! We offer routine...

  • Medical Receptionist/administrative Assistant

    6 months ago

    Winnipeg, Canada Aqua i Laser Full time

    Are you interested in the medical field and administrative work? Do you thrive in busy environments and like taking on new challenges? We are looking for **Full-Time Medical Receptionists / Administrative Assistants **to join our dynamic work environment alongside our bright and passionate team of staff and doctors. Aqua i Laser has been proudly serving...

  • Receptionist/administrative Assistant

    3 months ago

    Winnipeg, Canada Aqua i Laser Full time

    Are you interested in the medical field and administrative work? Do you thrive in busy environments and like taking on new challenges? We are looking for **Full-Time Medical Receptionists / Administrative Assistants **to join our dynamic work environment alongside our bright and passionate team of staff and doctors. Aqua i Laser has been proudly serving...

  • Pediatric Oncologist-hematologist

    7 months ago

    Winnipeg, Canada CancerCare Manitoba Full time

    **PEDIATRIC ONCOLOGIST-HEMATOLOGIST WITH **I**NTE**R**EST **I**N PEDIATR**I**C NEURO-ONCOLOGY**: ***: The Department of Pediatric Oncology and Hematology, CancerCare Manitoba consists of eight faculty members with active clinical and research programs in pediatric oncology, neuro-oncology, blood and marrow transplant, hematology, hemostasis and thrombosis....

  • Clinic Lead

    7 months ago

    Winnipeg, Canada Bayshore HealthCare Full time

    The clinic lead, under the direction of the Specialty Pharma Supervisor and/or Regional Specialty Pharma Manager, delivers and monitors specialized infusion or injectable pharmacological treatments in the home or clinic setting. The infusion nurse is responsible for monitoring the client for infusion related reactions (intervening as required), accurately...

  • Research Assistant I

    3 months ago

    Winnipeg, Canada Pan Am Clinic Foundation Inc. Full time

    **POSITION INFORMATION**: Classification**:RESEARCH ASSISTANT I** Position: Full-time Term (1-year) (non-union) Probation Period: 6 months **DESCRIPTION**: Pan Am Clinic Foundation Inc. is currently seeking a full-time Research Assistant. The Research Assistant is expected to assist with screening and consenting of study patients, collecting and entering...

  • Clinic Manager

    7 months ago

    Winnipeg, Canada Memorial Medical Clinic Full time

    Memorial Medical Clinic Ltd. operates two family practice medical clinics in Winnipeg MB. Memorial Medical Clinic is located at 595 Broadway and St. Vital Family Medical Clinic is located at 1087 St. Mary’s Road. Our team consists of 6 Physicians and 6 Medical Office Assistants. Work Location: In-Person - Office location will be at 595 Broadway location...

  • Clinical Specialist

    7 months ago

    Winnipeg, Canada BOMImed Inc. Full time

    BOMImed Inc. is on the lookout for a dedicated Clinical Specialist to join our team. In the heart of Winnipeg, Manitoba, our central manufacturing facility and nationwide team have positioned BOMImed as a prominent full-line supplier of medical devices and services across Canada. Since our inception in 1985, BOMImed has maintained an unwavering commitment to...

  • Clinic Manager

    6 months ago

    Winnipeg, Canada WELL Health Technologies Corp Full time

    **Entity: WELL Health Manitoba Clinic** **Position: Clinic Manager** **Type: Full Time** **Location: Manitoba** **About the Company**: WELL Health Manitoba Clinic is a private, multi-specialty medical clinic, founded in 1946. As one of Canada’s largest medical clinics, the facility comprises more than 30 physicians, mainly specialists. Manitoba Clinic...

  • Clinical Specialist

    6 months ago

    Winnipeg, Canada BOMImed Inc Full time

    BOMImed Inc. is on the lookout for a dedicated Clinical Specialist to join our esteemed team. Nestled within the heart of Winnipeg, Manitoba, our central manufacturing facility and nationwide sales team have positioned BOMImed as a prominent full-line supplier of healthcare products and services across Canada. Since our inception in 1985, BOMImed has...

  • Medical Clinic Manager

    25 minutes ago

    Winnipeg, Canada Atlantic medical centre Full time

    **Medical Office Manager Job**: Our medical clinic is currently seeking an enthusiastic, experienced and highly-motivated person to join and manage our practice. We are seeking a full time clinic manager to positively impact our current practice. **Duties and responsibilities**: All of the regular duties of a Medical Office Assistant Overseeing and guiding...

  • Data Management Analyst

    3 months ago

    Winnipeg, Canada The George & Fay Yee Centre for Healthcare Innovation Full time

    Job Description : Data Management Analyst - Information Technologist 3 (AESES) New Budget-Funded Continuing Full-Time 35.00 hours/week Monday to Friday 8:30 - 4:30 Salary Range: $32.51 - $46.90 per hour ($59,168.20 - $85,358.00 per annum) Proposed Start Date: October 28, 2024 Trial/Probation Period: 840.00 work hours For more information, please...

  • Investigator I

    7 months ago

    Winnipeg, Canada Canada Life Assurance Company Full time

    Investigator I **Description: - Permanent Full Time- We are looking for an**_ Investigator - Detection, Prevention & Integrity Services, Group Customer (DPIS)_** - The Investigator is a key member of the health and dental team that delivers robust and effective health and dental claims fraud prevention to Canada Life customers. The main function of the...

  • Winnipeg Clinical Nurse Specialist

    2 months ago

    Winnipeg, Manitoba, Canada Winnipeg Regional Health Authority Full time

    Role OverviewAs a registered nurse at the Winnipeg Regional Health Authority, you will play a critical role in delivering high-quality patient care in the Cardiac Science Intensive Care department. With a strong focus on clinical excellence and teamwork, we are seeking a dedicated and compassionate individual to join our team as a Registered...

  • Analyst I, Quality Assurance

    7 months ago

    Winnipeg, Canada Emergent Biosolutions Full time

    Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life. The Quality Assurance...

  • Clinic - Manager Clinic Medical Full Time

    3 months ago

    Winnipeg, Canada Winnipeg Humane Society Full time

    **Winnipeg Humane Society - Job Posting # 2024-09-18 **Date**:October 15th, 2024 **Position Title**: Manager, Clinic Medical - Full Time **Department**: Clinic **Reports to**: Director, Clinic Operations **Classification**: Non-Union 40 hours/week; Monday - Friday **Times & days of shifts could vary/change** **Start Date**: ASAP **Closing Date for...