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    Mgr, Ssu & Regulatory, Fsp Apac

    Syneos Health
    2+ years
    Not Disclosed
    Remote Australia
    10 Nov. 29, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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

    Manager, Site Start-Up & Regulatory

    Company: Syneos Health
    Location: Flexible

    About Syneos Health

    Syneos Health is a leading biopharmaceutical solutions organization, focused on accelerating customer success by delivering clinical, medical affairs, and commercial insights. With a commitment to patient-centered development and the continuous drive to simplify work processes, Syneos Health supports its clients in bringing innovative therapies to market faster. The company operates globally, with 29,000 employees across 110 countries.

    Why Syneos Health?

    • Growth & Development: Syneos Health values career development, offers professional training, and supports a culture where employees can authentically be themselves.
    • Diverse Culture: The company embraces diversity and is committed to building a workplace where everyone feels they belong.
    • Global Impact: Syneos Health plays a significant role in the development of FDA-approved drugs and EMA-authorized products.

    Role Overview

    As the Manager, Site Start-Up & Regulatory, you will lead a team responsible for site start-up, regulatory compliance, and ensuring successful project management of clinical trials. Your role will involve providing guidance on project processes, improving strategies, and maintaining strong relationships with internal teams and external stakeholders. You will also have a hands-on approach in managing and mentoring team members while facilitating effective site management and regulatory workflow.

    Key Responsibilities

    People Management & Team Leadership

    • Leadership: Conduct people management activities such as hiring, performance appraisals, employee development, and coaching.
    • Mentorship: Provide guidance and support to team members, helping them meet performance objectives and fostering a culture of professional growth.

    Site Start-Up & Regulatory Management

    • Site Start-Up: Oversee and manage site start-up processes, ensuring compliance with regulatory requirements.
    • Project Support: Assist in managing financials, risk analysis, and strategy development for site start-up projects. Facilitate reviews of clinical operations, focusing on project budgets and schedules.
    • Contract & Regulatory Workflows: Collaborate with the Legal Department to implement site contracts, develop start-up workflows, and maintain regulatory compliance across projects.

    System & Process Improvements

    • Project Management Systems: Implement and support project management tools and systems required by customers and the enterprise.
    • Process Improvement: Identify process risks and suggest improvements to enhance efficiency. Lead teams in the development of Standard Operating Procedures (SOPs) and Work Instructions (WIs) for site start-up and regulatory processes.
    • Quality Control: Oversee quality control efforts and develop strategies to track team performance and cycle times.

    Training & Communication

    • Training Development: Design and implement training materials for team members and other relevant stakeholders.
    • Professional Representation: Represent the company at professional meetings, seminars, and conferences, maintaining strong industry relationships.

    Qualifications

    Education & Experience

    • Degree: Bachelor’s Degree required.
    • Experience: Proven experience in a clinical research organization, specifically in contract management, site start-up, or regulatory processes.
    • Preferred Experience: Background in information systems management and process engineering.

    Skills

    • Knowledge: Familiarity with clinical trial regulations, drug development, and clinical project management procedures.
    • Leadership & Communication: Strong leadership abilities and excellent interpersonal skills, including the ability to coach and mentor team members.
    • Technical Proficiency: Proficient in MS Office (Word, Excel, PowerPoint), MS Project, and email.
    • Multitasking & Deadline Management: Ability to handle multiple tasks and meet deadlines while ensuring high-quality work.
    • Problem-Solving: Demonstrated ability to address technical problems, priorities, and workflow challenges.

    What We Offer

    • Dynamic Role: An impactful position within a global organization that prioritizes agility and continuous improvement.
    • Inclusive Culture: An environment where you can be your authentic self and grow professionally.
    • Competitive Benefits: Competitive salary, comprehensive benefits, and opportunities for growth.

    How to Apply

    If you are a motivated and experienced professional in clinical research and site start-up/regulatory processes, we encourage you to apply. Submit your resume and a cover letter detailing your experience and approach to site start-up and regulatory management.

    Syneos Health is committed to building a diverse and inclusive workplace and welcomes applications from candidates with transferable skills. Even if your experience doesn't align perfectly with every qualification, we encourage you to apply and join the Syneos Health Talent Network.

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