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    Clinical Trial Manager

    Nexpro Technologies Inc
    2-6 years
    $75 to $80 per hour
    Remote, USA
    10 Aug. 16, 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

    Location: Ridgefield, CT – Remote/Hybrid

    Duration: 12-month W2 contract with potential for extension or permanent placement

    Pay Rate: $68-$73/hour (Depending on Education and Experience)

    Overview: As a Clinical Trial Manager (CTM), you will be responsible for the operational management of the local components of clinical trials. Your primary role involves ensuring that trial recruitment targets are met, timelines are adhered to, budgets are managed efficiently, and both internal and external quality standards are maintained. This role requires strong leadership and coordination to ensure that clinical trials are conducted with the highest integrity and in compliance with regulatory requirements.

    Key Responsibilities:

    • Leadership: Lead the local trial team, ensuring the integrity of trial conduct and the safety of patients. Oversee the planning, execution, and reporting of the local/regional components of clinical trials.
    • Team Coordination: Orchestrate the activities of the local trial team and integrate with other functions throughout the trial phases, including preparation, conduct, and closeout.
    • Regulatory Compliance: Navigate complex GCP and regulatory environments, managing global clinical trials with multidisciplinary, international teams, and various stakeholders, including suppliers and investigational sites.
    • Representation: Act as the company's representative in internal and external meetings, including interactions with investigational sites and regulatory agencies/inspectors.
    • Project Management: Handle multiple assignments simultaneously, balancing conflicting priorities to ensure the successful delivery of trial objectives.
    • Innovation: Contribute to the design and implementation of innovative methods as a member of working groups.
    • Collaboration: Work closely with the Site Monitoring Lead and CRAs to ensure effective communication and trial management, serving as the primary trial contact for CRAs, investigators, and site staff.

    Skills and Qualifications:

    • Communication: Exceptional communication skills within complex cross-functional matrix structures, with the ability to articulate and align business strategies effectively.
    • Cultural Sensitivity: High-level receptive communication skills and cultural awareness.
    • Project Management: Strong project management, networking, stakeholder management, and team leadership capabilities.
    • Technical Expertise: Comprehensive knowledge of clinical trial operations and execution, with an understanding of the scientific and technical aspects of clinical development processes and associated regulatory requirements. Experience in a relevant Therapeutic Area is a plus.
    • Leadership and Influence: Ability to address complex situations, resolve conflicts, and influence both horizontally and vertically within the organization.
    • Strategic Mindset: Embrace cross-functional initiatives, apply innovative learnings, identify risks, and plan mitigation strategies.
    • Coordination and Oversight: Capable of setting priorities, managing the pace of activities, and efficiently utilizing resources.
    • Travel: Willingness to travel domestically up to 10-20% of the time.

    Education and Experience:

    • Bachelor's Degree: Minimum of 6 years of experience in clinical research, preferably within the pharmaceutical industry.
    • Master's Degree or PharmD: Minimum of 4 years of experience in clinical research, preferably within the pharmaceutical industry.
    • PhD or MD: Minimum of 2 years of experience in clinical research, preferably within the pharmaceutical industry.

    Compensation and Benefits:

    • Salary: Exempt salaried position, paid weekly.
    • Benefits: All BI holidays are paid, and sick time is provided per local statutes. Note that voluntary time off is not compensated.

    Work Environment:

    • The position is primarily remote, with occasional travel to Ridgefield, CT, as needed.

    About NexPro Technologies Inc: NexPro Technologies is committed to providing robust, responsive, and value-driven IT consulting and placement services. We pride ourselves on delivering high-quality solutions that meet the evolving needs of our clients and candidates alike.

     

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