Duration: Project-based (initial project duration: 6-12 months with potential for extension)
About Us: Our client are a cutting-edge biotechnology company focused on pioneering novel immunology therapies to address unmet medical needs. Our mission is to develop transformative treatments that can improve patients' lives. As we advance our early-phase clinical trials, we are seeking an experienced Freelance Clinical Trial Manager (CTM) to join our dynamic team.
Position Overview: The Freelancing Clinical Trial Manager will play a pivotal role in overseeing and managing early-phase clinical trials in the field of immunology. This role requires a highly organized, detail-oriented individual with a strong background in clinical trial management, particularly in early-phase (Phase I/II) studies. The CTM will be responsible for ensuring the successful execution of clinical trials, from study start-up to close-out, while adhering to regulatory requirements, timelines, and budget constraints.
Key Responsibilities:
Clinical Trial Planning and Management:
Develop and implement comprehensive clinical trial plans, including timelines, budgets, and resource allocation.
Oversee study start-up activities, including site selection, contract negotiations, and ethics committee submissions.
Manage day-to-day trial operations, ensuring adherence to protocols, SOPs, and regulatory guidelines.
Vendor and Site Management:
Identify, select, and manage external vendors, including CROs, laboratories, and data management organizations.
Establish strong relationships with investigative sites and ensure effective communication and collaboration.
Monitor site performance, including recruitment, enrollment, data collection, and adherence to protocol.
Regulatory Compliance and Quality Assurance:
Ensure compliance with ICH-GCP guidelines, FDA regulations, and other applicable local regulations.
Conduct or oversee site audits and inspections as necessary to ensure trial integrity.
Manage and resolve issues related to trial conduct, including deviations, adverse events, and data discrepancies.
Data Management and Reporting:
Collaborate with data management teams to ensure accurate and timely data collection, entry, and analysis.
Prepare and review clinical trial documentation, including protocols, case report forms, informed consent documents, and clinical study reports.
Provide regular updates and reports on trial progress, timelines, and milestones to internal stakeholders.
Team Leadership and Collaboration:
Lead cross-functional teams, including clinical operations, regulatory affairs, data management, and medical writing, to ensure trial success.
Facilitate effective communication between internal teams, external vendors, and investigative sites.
Mentor and provide guidance to junior team members as needed.
Qualifications:
Bachelor's or Master’s degree in Life Sciences, Nursing, Pharmacy, or a related field. Advanced degrees (e.g., Ph.D., PharmD) are a plus.
A minimum of 5 years of experience in clinical trial management, with a focus on early-phase (Phase I/II) trials in immunology or related therapeutic areas.
Strong understanding of ICH-GCP guidelines, FDA regulations, and clinical trial processes.
Proven track record of managing multiple clinical trials simultaneously, with a focus on early-phase studies.
Excellent project management skills, with the ability to manage timelines, budgets, and resources effectively.
Exceptional communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and external partners.
Ability to work independently, with a proactive and results-oriented mindset.
Experience with electronic data capture (EDC) systems and other clinical trial management tools.
Availability for periodic travel, as required, for site visits, audits, or meetings.
How to Apply: Interested candidates are invited to submit their resume, along with a cover letter detailing their relevant experience and availability. Please send your application to alex.smith@albionryeassociates.com.
Deadline for Applications: 23/08/2024
Equal Opportunity Employer: Our client are an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
This job description outlines the responsibilities, qualifications, and expectations for a Freelancing Clinical Trial Manager in an early-phase immunology biotechnology company. Adjustments can be made to reflect specific company needs or preferences.
Seniority level
Mid-Senior level
Employment type
Contract
Job function
Research, Science, and Project Management
Industries
Biotechnology Research, Pharmaceutical Manufacturing, and Hospitals and Health Care
Referrals increase your chances of interviewing at Albion Rye Associates by 2x