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    Project Manager Ii - Early Phase ** Sponsor Dedicated - Homebased Spain ** Immunology & Inflammation Experience Required

    Syneos Health
    2+ years
    Not Disclosed
    Remote - Europe
    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

    Project Manager II - Sponsor Dedicated (Home-Based in Spain) - Immunology & Inflammation Experience Required

    Company: Syneos Health
    Location: Home-based in Spain

    About Syneos Health

    Syneos Health is a leading global biopharmaceutical solutions organization. With a focus on accelerating customer success, they integrate clinical, medical affairs, and commercial insights to deliver results. Their approach emphasizes simplicity, agility, and a patient-centered philosophy.

    With a workforce of 29,000 employees across 110 countries, Syneos Health helps pharmaceutical companies bring innovative therapies to market faster.

    Why Syneos Health?

    • Career Development: Syneos Health fosters employee growth through career progression, technical training, peer recognition, and competitive rewards programs.
    • Inclusive Culture: Committed to a Total Self culture, Syneos Health supports an authentic work environment where diversity is valued and everyone can thrive.
    • Global Impact: In the past five years, Syneos Health has contributed to 94% of all FDA-approved novel drugs and 95% of EMA-authorized products.

    Role Overview

    The Project Manager II - Sponsor Dedicated position involves overseeing clinical research studies related to immunology and inflammation, ensuring they are conducted in compliance with Good Clinical Practice (GCP) and regulatory requirements. This role requires experience in project management, particularly in immunology and inflammation therapeutic areas, and a strong understanding of clinical trial management.

    Key Responsibilities

    Project Leadership and Delivery

    • Project Management: Lead and manage clinical research studies, ensuring all stages, from initiation to closeout, are in compliance with GCP, SOPs, and regulatory requirements.
    • Client Liaison: Serve as the primary point of contact between the company and clients, ensuring study progress aligns with contractual agreements.
    • Team Leadership: Oversee and lead interdisciplinary project teams, ensuring quality, timelines, and budget adherence.
    • Financial Management: Monitor the financial performance of the projects to ensure they remain within budget.

    Documentation and Reporting

    • Trial Master File (TMF) Management: Ensure the quality and completeness of TMF for assigned projects.
    • Data and Study Management: Maintain up-to-date study information on various platforms, ensuring readiness for inspections and audits.
    • Project Reporting: Prepare and present project management reports to both clients and internal management teams.
    • Risk Management: Develop and implement contingency plans and risk mitigation strategies to ensure successful study outcomes.

    Business Development

    • Client Relationship Management: Build strong relationships with existing clients to drive future business opportunities.
    • Bid Defense: Participate in bid defense meetings to represent Syneos Health and secure new project contracts.

    Management Responsibilities

    • Team Leadership: Potentially manage other project management team members and clinical monitoring staff.

    Qualifications

    Education and Experience

    • Degree Requirement: A Bachelor’s degree in Life Sciences, Medicine, Pharmacy, Nursing, or a related field, or an equivalent combination of education and experience.
    • Therapeutic Expertise: Significant experience in Immunology & Inflammation clinical research and project management.
    • CRO Experience: Experience with Clinical Research Organizations (CROs) and a strong understanding of GCP and regulatory requirements related to immunology and inflammation studies.

    Skills

    • Project Management: Strong organizational and time management skills, with the ability to handle multiple projects independently.
    • Leadership: Proven ability to lead cross-functional teams and ensure collaboration among study partners.
    • Communication: Excellent written and verbal communication skills, capable of presenting and communicating complex project details effectively.
    • Technological Adaptability: Comfort with using and embracing new technologies for clinical study management.

    Additional Requirements

    • Travel: Willingness to travel up to 25% for site visits and meetings, as necessary.

    Compensation & Benefits

    • Competitive Salary: Compensation is based on experience and qualifications.
    • Comprehensive Benefits: Health benefits, retirement plans, paid time off (PTO), and more.

    How to Apply

    If you have experience managing clinical studies in immunology and inflammation and are ready to join a dynamic global team, apply today to Syneos Health!

    Note: Syneos Health values diversity and inclusion and encourages all qualified candidates to apply, even if their qualifications are not an exact match for the listed requirements.

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