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    Project Manager Study-Start-Up (W/M/D), Sponsor-Dedicated - Deutschland

    Fortrea
    5+ years
    Not Disclosed
    Munich Remote, USA
    10 Nov. 21, 2024
    Job Description
    Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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

    Job Description: Project Manager Study Start-Up - Flexible Solutions at Fortrea

    Fortrea, a global leader in contract research, is seeking a Project Manager Study Start-Up to join our Flexible Solutions team. In this role, you will play a pivotal role in the successful execution of clinical trials for new drugs, specifically within the oncology field, by working directly with one of the world’s top 5 pharmaceutical companies. This position offers a unique opportunity to contribute to the development of groundbreaking therapies while exclusively supporting one of our major international clients.

    What You Can Expect:

    • A meaningful role in a stable, diverse, and successful global organization.
    • Competitive compensation package, including a 13th salary and vacation pay.
    • Genuine work-life balance with flexible hours and vacation compensation.
    • Travel time counted as work time.
    • Comprehensive onboarding and personal mentorship support.
    • Permanent home-office contract.
    • Employer-funded pension plan.
    • Excellent opportunities for professional development and continued learning.
    • Ongoing support from your line manager.

    Key Responsibilities:

    • Organize and manage all necessary submissions and applications to ethics committees and regulatory authorities in Germany.
    • Coordinate local study start-up processes, including vendor management.
    • Manage framework and site contracts, budget, and payments.
    • Adapt global study documents to meet local requirements.
    • Collaborate closely with internal and external teams to ensure smooth operations.
    • Participate as a Subject Matter Expert (SME) in customer-specific working groups and other internal projects.

    Your Background:

    • Degree in a relevant life science field such as Biology, Biochemistry, Chemistry, Pharmacology, Medicine, or similar. Alternatively, a relevant health/clinical background (e.g., Study Nurse, Research Nurse, Study Coordinator) or equivalent professional experience.
    • Strong experience in Study Start-Up processes.
    • Practical experience with submissions to German ethics committees and regulatory bodies.
    • Experience in contract management and financial processes.
    • Proven leadership skills through mentoring, coaching, and/or team coordination.
    • Excellent time management, organizational skills, and a keen eye for detail.
    • Outstanding communication skills in fluent German and strong English, both written and spoken.

    Fortrea is actively seeking motivated, creative problem-solvers who are passionate about overcoming challenges in clinical trials. We are committed to transforming the development process to ensure the swift delivery of life-changing therapies to patients worldwide. Join our exceptional team and thrive in a collaborative work environment that fosters personal growth and global impact.

    For more information about Fortrea, visit www.fortrea.com.

    Fortrea is an Equal Opportunity Employer: Fortrea values diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on business needs and the qualifications of the individual, without regard to race, religion, color, national origin, gender, sexual orientation, gender identity, disability, or other legally protected characteristics.

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