Remote Clinical Research Protocol Writer Jobs in Raleigh, NC

Job Posting Title- Clinical Trial Lead

Location: Home-based in the U.S.

Responsibilities & Key Tasks

Lead global, cross-functional trial teams to ensure successful delivery of complex Phase III studies, with accountability for timelines, quality, and strategic oversight.

Serve as the primary contact for internal and external stakeholders regarding trial progress, governance, and issue resolution.

Author and manage essential trial documentation including protocols, informed consent forms (ICFs), study management plans, and integrated quality plans.

Provide strategic input and make scientific or medical decisions in early clinical development, in alignment with medical colleagues when applicable.

Ensure consistent use of study tools, training materials, and adherence to GCP/ICH guidelines, SOPs, and regulatory requirements.

Lead interdisciplinary core trial teams (e.g., data management, statistics, pharmacokinetics, clinical operations) and facilitate Trial Oversight Meetings.

Collaborate cross-functionally to support milestone achievement and proactively manage study risks and mitigation strategies.

Manage and mentor clinical operations staff, including performance appraisals, development planning, and resolution of employee relations issues.

Provide coaching on project planning, risk management, and problem-solving to ensure global alignment and adoption of process and technology tools.

Support staff in achieving project deliverables on time and within budget, ensuring quality and compliance with contractual obligations.

Monitor and guide financial aspects of trials including scope, budget, schedule, and change control.

Conduct regular performance reviews using dashboards and metrics, ensuring accurate reporting and system compliance.

Plan trial quality and risk monitoring/ mitigation. Identify and address quality issues within studies, implementing corrective and preventive actions as needed.

Perform continuous review, risk identification, evaluation/ analysis and communication on a trial level as applicable.

Lead or contribute to corporate initiatives, process improvements, and cross-functional collaborations.

Train and support staff on clinical trial processes, systems, and competency frameworks to foster continuous development.

Consult with pharmacogenetics and safety experts on preclinical data, adverse events (SAEs, SUSARs), and side effect profiles as needed.

Demonstrate therapeutic area expertise (e.g., oncology, inflammatory, CMR (cardiovascular-metabolic renal)) and apply clinical pharmacology knowledge to study design and execution.

Maintain fluency in English, with effective communication and leadership capabilities.

REQUIRED KNOWLEDGE, SKILLS AND EXPERIENCE

Master's or higher-level degree in life sciences or related field. An education as a physician would be a plus.

Minimum of 5 years (or 10 years for Senior CTL role) of global clinical operations management experience, preferable within a global CRO environment.

Experience in set-up and conduct of Phase III clinical trials including in depth knowledge study designs, and protocol writing.

Knowledge of applicable clinical research regulatory requirements e.g. GCP / ICH guidelines, CTR and relevant local laws.

Therapeutic area knowledge in oncology, inflammatory or CMR would be required and experience in any of the following would be an advantage: respiratory, CNS, ophthalmology.

Computer skills including good knowledge of Microsoft Word, Excel and PowerPoint.

Fluent language skills in English.

Effective communication, organizational and problem-solving skills.

Strong leadership competencies and ability to establish and maintain effective working relationships.

Required Qualifications & Competencies

Education: Master's degree or higher in life sciences or a related field is required; medical education (e.g., physician) is considered a strong asset.

Experience: Minimum of 10 years of relevant experience in clinical research, including at least 5 years in global clinical operations and trial management with leading a clinical team in a matrix structure, preferably within a global CRO or pharmaceutical environment.

Clinical Expertise: Proven experience in the setup and conduct of Phase III clinical trials, with deep knowledge of study designs, protocol development. Further experience in Phase II trials is considered beneficial.

Regulatory Knowledge: Strong understanding and practical application of clinical research regulatory requirements, including GCP, ICH guidelines, and relevant local laws.

Therapeutic Area Knowledge: Familiarity with therapeutic areas such as oncology, inflammatory, CMR

Leadership & People Management: Demonstrated ability to lead and manage global clinical teams in a matrix structure, delegate effectively, provide coaching and feedback.

Collaboration & Communication: Excellent interpersonal and communication skills, with the ability to work across geographies and cultures, and build strong relationships with internal and external stakeholders.

Organizational Skills: Strong planning, organizational, and problem-solving abilities, with a proven track record of managing competing priorities and delivering results to quality and timeline metrics.

Customer Focus & Decision-Making: Ability to understand customer needs, navigate complex discussions, and negotiate effective solutions. Demonstrates sound judgment and decision-making capabilities.

Learning Agility: Committed to continuous learning and development, with openness to evolving industry practices and technologies.

Technical Proficiency: Strong computer skills, including proficiency in Microsoft Word, Excel, PowerPoint, and clinical trial management systems.

Language Skills: Fluent in English.

Core Competencies: Demonstrates key competencies such as Client Focus, Collaboration, Communication, Innovation, and Ownership.

• Extensive experience leading late-stage clinical trials (Phase III) and the ability to quickly integrate into ongoing programs
• Demonstrated ability to appropriately identify and escalate issues when needed
• Strong proactive risk management skills
• Proven capability to effectively manage conflict and navigate challenging situations
• Experience working within and successfully navigating complex matrix organizations
• Excellent communication and stakeholder management skills
• Strong project management capabilities, including:
  • Defining clear expectations
  • Establishing realistic timelines
  • Effective prioritization and time management
  • Maintaining a logical and organized approach to execution

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IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more athttps://jobs.iqvia.com

IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.