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Manager, Clinical Operations - Full Service Cra Manager (Home-Based In Canada)

0-2 year years
Not Disclosed
10 Feb. 7, 2025
Job Description
Job Type: Remote Education: Bachelor’s degree in life sciences, nursing degree, or equivalent related experience Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Company Overview

Syneos Health® is a leading, fully integrated biopharmaceutical solutions organization focused on accelerating customer success. We combine clinical, medical affairs, and commercial insights to drive outcomes that address modern market realities.

Our Clinical Development model places the customer and patient at the center of our efforts. We continuously seek ways to simplify and streamline processes to enhance collaboration and efficiency.

With 29,000 employees across 110 countries, Syneos Health is dedicated to transforming lives through innovative solutions.


 

Job Responsibilities

People Management:

  • Line management of Clinical Operations staff, including interviewing, hiring, professional development, performance appraisals, and employee counseling.

  • Assign project work, review workloads, and ensure proper delegation of tasks.

  • Establish goals to enhance team knowledge and skill levels.

  • Ensure staff retention and manage turnover rates within expected levels.

  • Oversee training plans and address performance deficiencies.

  • Conduct clinical staff meetings and manage follow-up actions.

Operational Oversight:

  • Review workload and resource availability for assigned staff to ensure timely project staffing.

  • Provide expert operational oversight, prioritize activities, monitor work performance, and ensure metric compliance.

  • Support quality adherence to Standard Operating Procedures (SOPs), Work Instructions (WIs), and ICH-GCP guidelines.

  • Ensure staff completes required training and documentation.

  • Oversee quality control efforts and identify performance/process improvements.

Performance & Compliance:

  • Monitor and ensure staff performance aligns with study requirements, addressing deficiencies as needed.

  • Participate in business unit-level process improvements.

  • Conduct sign-off and assessment visits to evaluate Clinical Operations performance.

  • Utilize department systems, reports, and dashboards for performance tracking and risk analysis.

Recruitment & Development:

  • Assist in recruiting new staff, including interviewing and onboarding.

  • Support training and development initiatives.

  • Collaborate with senior management to ensure continuous professional growth of team members.


Qualifications & Requirements

  • Education: Bachelor's degree in life sciences, nursing, or equivalent experience.

  • Experience: Extensive clinical research experience within a CRO, pharmaceutical, or biotech company, including leadership experience.

  • Regulatory Knowledge: Strong understanding of GCP/ICH guidelines and other regulatory requirements.

  • Skills:

    • Excellent communication, presentation, and interpersonal skills.

    • Strong time management, technical, and organizational skills.

    • Ability to work independently and within a team environment.

    • Financial acumen related to forecasting and budgeting.

    • Proficiency in modern technologies and computer systems.


About Syneos Health

  • Over the past 5 years, we have collaborated on 94% of all Novel FDA-Approved Drugs and 95% of EMA-Authorized Products.

  • We have conducted over 200 studies across 73,000 sites, reaching more than 675,000 trial patients.

  • Our mission is to challenge the status quo in a dynamic and competitive industry.


Additional Information:

  • Tasks and responsibilities listed above are not exhaustive and may be subject to change.

  • Equivalent experience, skills, and education will be considered.

  • Compliance with employment and disability legislation, including reasonable accommodations, will be ensured.

  • Employment does not constitute a contract and is subject to company discretion.

Join Syneos Health – Work Here Matters Everywhere!