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    Clinical Project Manager Ii - Early Phase/ Site Evaluation (50% Travel/ Prior Senior Cra Experience Required)

    Syneos Health
    2+ 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: Hybrid (Remote, with travel to clinical sites required 1-2 times per month)

    About Syneos Health

    Syneos Health is a premier biopharmaceutical solutions organization dedicated to accelerating customer success. With over 29,000 employees in 110 countries, Syneos Health provides integrated clinical, medical, and commercial insights to meet modern market challenges and drive success in biopharmaceutical development.

    Why Syneos Health?

    • Career Development: Opportunities for professional growth with a focus on career progression, technical training, and peer recognition.
    • Inclusive Culture: Syneos Health values diversity and encourages an environment where employees can be their authentic selves.
    • Global Impact: Join a team that is working toward accelerating the delivery of therapies to patients worldwide.

    Role Overview

    The Project Manager II will oversee interdisciplinary clinical research studies and ensure compliance with GCP (Good Clinical Practice), SOPs, and regulatory requirements. This hybrid, sponsor-dedicated role combines responsibilities of a Clinical Project Manager and Senior Clinical Research Associate (CRA) for Early Phase clinical trials. This position offers flexibility to work remotely across the U.S., with up to 50% travel to clinical sites.

    Key Responsibilities

    Project Leadership and Delivery:

    • Lead project teams to ensure quality, timelines, and budget management.
    • Act as the primary liaison between the company and the client to ensure timely study launches, conduct, and closeouts.
    • Oversee the financial performance of each project and ensure effective coordination of study conduct activities.
    • Proactively identify and manage issues related to study execution.
    • Ensure that studies comply with GCP, SOPs, and regulatory requirements.

    Documentation and Reporting:

    • Ensure the quality and completeness of the Trial Master File (TMF) for all assigned projects.
    • Maintain study information on various databases and systems.
    • Ensure inspection readiness for all study aspects.
    • Develop and implement project plans, prepare reports, and present at meetings.
    • Create contingency plans and risk mitigation strategies.

    Business Development:

    • Build and nurture relationships with clients to foster business growth and secure additional business opportunities.
    • Participate in bid defense meetings, where applicable.

    Management:

    • May involve managing other project management team members and clinical monitoring staff.

    Qualifications

    Required Experience & Skills:

    • Bachelor’s Degree in Life Sciences, Medicine, Pharmacy, Nursing, or equivalent.
    • Previous CRO experience and therapeutic area expertise are highly preferred.
    • Strong knowledge of Good Clinical Practice (GCP), ICH guidelines, and relevant regulatory requirements.
    • Excellent organizational and time-management skills.
    • Ability to work independently and handle multiple tasks efficiently.
    • Strong communication skills (both written and verbal), including the ability to present and collaborate with diverse teams.
    • Travel: Willingness to travel approximately 25%.

    Compensation & Benefits

    Syneos Health offers a competitive salary, along with a comprehensive benefits package:

    • Health benefits (Medical, Dental, Vision).
    • 401(k) with company match.
    • Eligibility to participate in the Employee Stock Purchase Plan and earn performance-based commissions/bonuses.
    • Flexible paid time off (PTO) and sick leave.

    The annual base salary for this position ranges from USD $85,500 - $175,700, depending on qualifications, skills, and experience.

    Apply Now to take the next step in advancing your career and join a global team working to bring innovative therapies to market faster.

    Syneos Health is an equal opportunity employer and encourages applicants from all backgrounds to apply.

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