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    Clinical Project Manager Ii - Oncology & Vendor Mgt Experience Required (Sponsor Dedicated/ Foster City, Ca Or Remote)

    Syneos Health
    3+ years
    $85,500 to $175,700
    Remote, USA
    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

    Company: Syneos Health
    Location: Foster City, CA (Preference for local candidates; home-based options considered)

    About Syneos Health

    Syneos Health is a global leader in providing integrated biopharmaceutical solutions, helping to accelerate the success of their customers by translating clinical, medical, and commercial insights into impactful outcomes. The company is committed to simplifying its processes to make working with them easier, while creating an environment where employees are empowered to innovate and collaborate.

    Syneos Health is dedicated to changing lives by bringing new therapies to market faster, powered by over 29,000 employees in 110 countries.

    Why Syneos Health?

    Syneos Health emphasizes career development, offering robust programs for progression, training, and peer recognition. They are committed to creating a supportive culture that fosters authenticity, inclusion, and personal well-being. The company values diverse perspectives and works hard to build an environment where everyone can thrive.

    Role Overview

    As a Sponsor Dedicated Oncology Clinical Project Manager II, you will be responsible for managing global oncology clinical trials. You will oversee the entire project lifecycle, from start-up to close-out, and ensure alignment with regulatory requirements, timelines, budgets, and quality standards. You will work closely with interdisciplinary teams and manage relationships with external vendors to drive successful trial delivery.

    Key Responsibilities

    Project Leadership and Delivery:

    • Manage and oversee interdisciplinary clinical research studies, ensuring compliance with Good Clinical Practice (GCP), relevant SOPs, and regulatory requirements.
    • Act as the primary liaison between Syneos Health and the customer to ensure timely study launch, execution, and close-out according to the contractual agreement.
    • Lead the project team to ensure quality, timelines, and budget management.
    • Ensure the financial performance of each project is optimized.
    • Coordinate activities and deliverables of all study conduct partners and proactively address issues to ensure smooth execution.
    • Develop and implement project plans and risk mitigation strategies to meet study goals.

    Documentation and Reporting:

    • Ensure the quality and completeness of the Trial Master File (TMF) and other project documentation.
    • Maintain study information across various databases and systems.
    • Oversee study components to ensure inspection readiness.
    • Prepare and present project management reports to both clients and management.
    • Plan and conduct internal and external meetings as needed to report progress and resolve issues.

    Business Development:

    • Build and nurture strong relationships with existing clients to generate future business opportunities.
    • Participate in bid defense meetings and contribute as a potential project manager during business development efforts.

    Team Management:

    • May be required to manage and mentor other project management team members and clinical monitoring staff.

    Qualifications

    Experience & Skills:

    • Bachelor’s Degree (or equivalent) in life sciences, medicine, pharmacy, nursing, or a related field.
    • 3+ years of experience in clinical project management, specifically within oncology, at a CRO or pharmaceutical company.
    • Deep understanding of oncology therapeutic areas, with direct therapeutic area expertise.
    • Strong knowledge of GCP, ICH guidelines, and other relevant regulatory requirements.
    • Proven ability to manage multiple projects, timelines, and budgets simultaneously.
    • Excellent organizational, communication, presentation, and interpersonal skills.
    • Ability to travel as required (approximately 25%).

    Technology & Other Skills:

    • Comfort with new technologies and clinical research systems.
    • Ability to work independently and manage time effectively.

    Why Work with Us?

    • Career Growth: Syneos Health provides opportunities for advancement and development through a range of training and recognition programs.
    • Inclusive Culture: A commitment to diversity and inclusion, fostering an environment where all employees feel they belong.
    • Global Impact: Work with a company involved in over 94% of all novel FDA approved drugs and 95% of EMA authorized products.

    Compensation & Benefits:

    • Competitive annual base salary ranging from $85,500 to $175,700, based on qualifications and experience.
    • Comprehensive benefits package, including health, dental, and vision insurance, 401(k) match, Employee Stock Purchase Plan, flexible paid time off (PTO), and more.
    • Company car or car allowance for eligible positions.

    Apply Now to become part of a team that is driving innovation and changing lives in oncology research.

    Syneos Health is an equal opportunity employer, and applicants from all backgrounds are encouraged to apply.

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