Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change, and accelerate progress. Over the past 5 years, we have worked with: 94% of all Novel FDA Approved Drugs 95% of EMA Authorized Products Over 200 Studies across 73,000 Sites and 675,000+ Trial patients
Clinical Operations Specialist – Bilingual English/French
Location
Canada
Posted
6 days ago
Salary
0
Seniority
Senior
Job Description
Clinical Operations Specialist – Bilingual English/French
Syneos Health
• Preparing and coordinating regulatory submissions to Health Canada, Research Ethics Boards (REBs), and Institutional Review Boards (IRBs). • Completing and maintaining Clinical Trial Site Information (CTSI) documentation. • Managing regulatory documents and study files to ensure compliance and inspection readiness. • Supporting multiple clinical studies simultaneously (typically 15+ active protocols). • Processing clinical trial invoices accurately and efficiently. • Tracking study documentation, regulatory milestones, and operational deliverables. • Working cross-functionally with clinical operations, regulatory, and study teams to ensure timely study execution. • Maintaining accurate records within study systems and databases. • Supporting study start-up, maintenance, and closeout activities while ensuring adherence to sponsor processes and regulatory requirements.
Job Requirements
- Fluency in both English and French (written and spoken).
- Approximately 3+ years of clinical operations, clinical project associate, or equivalent clinical research experience.
- Strong working knowledge of Health Canada regulations.
- Extensive experience preparing and submitting regulatory packages to Health Canada.
- Experience with Research Ethics Board (REB) and/or Institutional Review Board (IRB) submissions.
- Hands-on experience completing Clinical Trial Site Information (CTSI) forms.
- Experience processing clinical trial invoices.
- Ability to successfully manage 15 or more concurrent clinical protocols.
- Exceptional organizational skills with strong attention to detail.
- Ability to work independently in a fully remote environment while managing multiple priorities.
Benefits
- 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 building an inclusive culture – where you can authentically be yourself.
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• Manages staff, providing coaching, mentorship and work direction • Conducts regular performance appraisals and career discussions with staff. Facilitates employee career development. Interviews, recruits and selects staff. • Manages and conducts induction/orientation programs for all new employees, ensuring their smooth assimilation into the company. • Ensures all staff CVs, training records, position profiles and experience profiles are complete and up-to-date. Ensures timeliness and accuracy of timesheets and expense reports. • Supports allocation activities per the local resourcing process. Supports activities of project leads/functional leads to optimize the operational running of projects. Raises appropriately any issues which may impact project deliverables. • Delivers training on Working Practice Documents (WPDs) and Standard Operating Procedures (SOPs), local requirements and any other subjects that impact on clinical operations. Identifies training gaps and ensures that training requirements are met. May contribute to development of training programs, where appropriate. • Assures adherence to good ethical and regulatory standards. • Alerts management to quality issues, request QA audits as appropriate, and facilitate client and internal quality assurance audits as required. • Handles and reviews systems (e.g. Activate, CTMS, Preclarus, Clarity) to evaluate employee and project metrics, KPIs and general project status. • Evaluates work of staff, including conducting PAVs (either remote or on-site) to thoroughly evaluate the employee monitoring skills and project conduction when applicable. • Participates in process improvement/development initiatives. • Ensures understanding and facilitation of the risk-based monitoring approach. • May provide input into bids and contribute to the procurement of new business where required. • Collaborates with clinical operations senior management and executive staff on strategic planning and business development as required. • May lead or contribute to initiatives that enhance the department's performance or lead to process improvement across the company.
• Function as a member of the study-specific project team for simple systems, including understanding the systems, providing support related training of the systems and is responsible for the completion of all support related project deliverables. • Assist functional area leads and senior peers in identifying and evaluating fundamental issues on projects. • Gather information regarding potential or actual risks/issues and provide detailed information to management to ensure risks/issues are surfaced and mitigated. • For simple systems, perform study specific informal testing, create and review study specific system support guidelines for accuracy and completeness. • Prepare, coordinate and deliver meeting materials and communications per timeline milestones. Attend meetings and communications with sponsors, vendors and cross-functional team members. • Serve as a support escalation contact for simple systems for study-specific questions/issues
Director, AI Engineering--Clinical Development and Operations (CD&O)
PfizerOur purpose ensures that patients remain at the center of all we do. We live our purpose by sourcing the best science in the world; partnering with others in the healthcare system to improve access to our medicines; using digital technologies to enhance our drug discovery and development, as well as patient outcomes; and leading the conversation to advocate for pro-innovation/pro-patient policies.
POSITION SUMMARY In this "hands-on" position, you will design, build, and deploy production-grade AI systems that will power enterprise-scale capabilities across the Clinical Development & Operations organization. This is a high-impact role for a builder who thrives on solving real-world business problems in a complex, data-rich, and regulated environment. You will be instrumental in advancing the practical application of LLMs and agentic AI by identifying high-value use cases, developing reusable workflows, and partnering with stakeholders to drive adoption and impact. Combining deep expertise in software engineering and machine learning, you will take solutions from prototype to production, embedding MLOps best practices to ensure they are reliable, scalable, and reproducible. You will drive business transformation through proactive thought-leadership, innovative analytical capabilities, and the ability to communicate highly complex information in new and creative ways. WHAT YOU"LL DO Develop and Implement AI Solutions - Build and deploy AI/ML models and solutions that support process-heavy workflows (e.g. protocol feasibility and site selection, study start-up etc.) including documentation, and operational reporting. - Contribute to the automation of manual and repetitive activities to improve speed, quality, and consistency. Strengthen Operational Decision-Making - Develop predictive, optimization, and scenario-based models to support clinical trial supply forecasting and operational planning. - Create and maintain dashboards and decision-support tools that translate complex data into actionable insights for CD&O leadership and operational teams. Engineer Production-Grade AI Systems - Implement AI solutions that are aligned with data integrity standards and governance best practices, including model validation, versioning, and monitoring. - Design and implement AI agentic solutions that can plan and execute multi-step workflows. - Build robust, production-ready ML and analytics pipelines with a focus on reproducibility and scalability. - Deploy AI solutions in cloud environments, ensuring reliability, security, and seamless integration with existing systems. Collaborate Across Disciplines - Partner closely with CD&O line teams, scientists, and Digital partners to ensure that AI efforts remain tightly aligned to real scientific needs and can be deployed in ways that are trusted, scalable, and adopted in day-to-day work. - Champion best practices in AI engineering system lifecycle. BASIC MINIMUM QUALIFICATIONS - PhD in Computer Science, Machine Learning, Data Science, Software Engineering, AI, or a related discipline and a minimum of 5 years of applied analytical experience with demonstrated impact in operations, automation, business analytics, or decision support OR - Master's in Computer Science, Machine Learning, Data Science, Software Engineering, AI, or a related discipline and a minimum of 7 years of applied analytical experience with demonstrated impact in operations, automation, business analytics, or decision support. - Strong hands-on experience applying LLMs, generative AI, machine learning, or related AI approaches to real-world workflows, products, or analytical use cases, ideally within R&D, clinical operations or large-scale regulated organizations. - Experience building practical, reusable workflows or systems rather than one-off analyses, with strong implementation skills in Python and modern AI / ML tooling. - Sound judgment regarding methodological rigor, model limitations, evaluation, and the appropriate role of human oversight in AI-enabled workflows. - Experience working directly with domain users or stakeholders to translate ambiguous needs into useful technical solutions, with evidence of strong collaboration and communication skills. TECHNICAL SKILLSET - AI Engineering/ Framework: Strong hands‑on experience with Python building ML/DL with libraries (e.g. TensorFlow, PyTorch, Keras, Scikit-learn), and LLM‑based systems and agentic frameworks including RAG architectures, prompt engineering, embeddings, fine‑tuning, evaluation and orchestration (e.g. ADK, LangChain, LangGraph, Vertex AI, Claude). - Software & Data Engineering/ Framework: Experience with Java, JavaScript/TypeScript, React, FastAPI, SQL/PostgreSQL, Snowflake, S3, and enterprise data and knowledge systems (e.g. BigQuery, Neo4j). - Cloud, DevOps & MLOps: Proficient with Git, Docker, CI/CD, and cloud platforms (AWS/GCP/Azure), with a strong focus on reproducibility, deployment, monitoring, and production‑ready MLOps. PREFERRED QUALIFICATIONS - Experience in life sciences, pharma, biotech, systems biology, immunology, translational science, omics, or related research environments. - Experience operating across scientific and technical disciplines, with enough domain fluency to engage credibly with scientists while still bringing a strong applied-AI builder mindset. Work Location Assignment: This is a hybrid role requiring you to live within commuting distance and work on-site an average of 2.5 days per week. Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact. NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS Occasional travel may be required to collaborate with colleagues across Pfizer sites, participate in workshops, support adoption activities, or engage with internal and external partners. The annual base salary for this position ranges from $176,600.00 to $294,300.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 20.0% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site - U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States. This role is posted in multiple locations. If you are applying for the role in an secondary job posting location where pay transparency regulations apply, your Talent Advisor will share the local pay information with you during the first interview. Relocation assistance may be available based on business needs and/or eligibility. Candidates must be authorized to be employed in the U.S. by any employer. U.S. work visa sponsorship (such as TN, O-1, H-1B, etc.) is not available for this role now or in the future. Sunshine Act Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative. EEO & Employment Eligibility Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States. Pfizer endeavors to make www.pfizer.com/careers accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email disabilityrecruitment@pfizer.com . This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned. To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers . Information & Business Tech
Senior Clinical Quality Manager, AI Transformation
Spring HealthPrecise. Personal. Proven. The most comprehensive mental health care for teams and families everywhere.
• Lead complex cross-functional initiatives from strategy through implementation using AI-first technology solutions, optimizing automations and intelligent decision support: • Transform provider policies, SOPs, playbooks, and clinical resources into engaging, interactive tools aimed to improve provider care quality and effectiveness and help them maintain compliance with all legal, regulatory, and payer requirements • Innovate provider performance feedback tools to amplify provider strengths, address risks and areas for improvement, offer focused education and ongoing professional development to hone their skills, and equip them with resources and actionable steps to achieve these goals • Design scalable quality team operational workflows that improve efficiency, reduce manual work, and enhance provider experiences. • Drive systems integrations across enterprise tools to strengthen monitoring of quality improvement initiatives that drive care delivery outcomes and identify strategic opportunities for continuous improvement • Assist in developing reporting standards for compliance and quality of care, including establishing review criteria and recommending new innovations in processes to better evaluate success • Develop and maintain policies that support compliance with accreditation and regulatory standards (e.g., CARF, NCQA). • Serve as a strategic leader in Fraud, Waste, and Abuse (FWA) prevention initiatives. • Lead and/or participate in additional projects as assigned.



