Clinical Trial Manager
To support the growth of our client's Global Clinical Trial Operations team, we are seeking a Clinical Trial Manager.
The Clinical Trial Manager (CTM) plays a pivotal role, overseeing the operational aspects of clinical studies from the Final Protocol Concept Sheet to the Clinical Study Report (CSR) and relevant results disclosure. The CTM ensures that trials are conducted within quality standards, timelines, and budget, adhering to applicable SOPs and regulatory requirements.
Under the guidance of a Lead, the CTM takes on a subset of clinical trial management duties. For less complex trials, the CTM may lead the cross-functional team in collaboration with the Lead Trial Physician. Responsibilities include operational planning, global coordination, and implementation of assigned studies. The CTM is responsible for establishing and maintaining timelines and budgets, overseeing external partners, managing risks and issues, and making contingency plans and decisions. The CTM acts as the “Operational Voice” for assigned studies, both internally and externally.
Ideal candidates will have experience in managing global clinical trial operations, overseeing CROs, and handling feasibility, start-up, execution, and study closure. They should demonstrate humility and effective partnership skills to achieve excellence.
The CTM will report to the Clinical Operations Development Lead.
The Clinical Trial Manager (CTM) is tasked with overseeing the cross-functional execution of global clinical trials from preparation to closure. Key responsibilities include:
- Establishing and Leading the team: If necessary, form and lead the cross-functional Clinical Trial Team (CTT) in collaboration with the Lead Trial Physician. Coordinate with functional leaders to assign CTT representatives from relevant areas.
- Ensuring Compliance: Execute clinical trials in line with protocol requirements, trial plans, OGSM, argenx procedures, ICH-GCP, and other regulations. Maintain clear and transparent communication with CTT members and external partners to meet trial objectives.
- Managing Trial Progress: Oversee cross-functional planning, track study progress, and proactively manage the completion of trial deliverables and milestones.
- Vendor Oversight: Lead, guide, and oversee CROs and other vendors to ensure they meet contractual obligations according to plan and metrics.
- Risk Management: Identify and mitigate risks, suggest and collaborate on solutions, manage contingency planning, and oversee implementation. Implement corrective and preventative actions as needed. Escalate significant risks or issues to senior management.
- Vendor Selection and Contracting: Contribute to the evaluation, selection, and contracting of CROs and vendors. Ensure the scope of work aligns with protocol requirements, budget, and timelines. Oversee contract management and ensure services are delivered as per the contract.
- Training and Meetings: Ensure CTT members, including CRO and vendor teams, receive appropriate trial-specific training. Oversee the setup, coordination, and conduct of Investigator Meetings.
- Development of Trial Materials: Develop or contribute to trial-related materials such as clinical protocols, study training materials, pharmacy manuals, clinical monitoring plans, data management plans, eCRFs, patient information, informed consent forms, site instructions, and recruitment and retention materials.
- Reducing Burden: Act with the mindset of reducing patient and site burden throughout the trial.
- System and Process Configuration: Ensure vendor systems and processes are configured according to protocol requirements and regulations. Contribute to project specifications, user acceptance testing, implementation, and change management.
- Feasibility and Alignment: Oversee the country and site feasibility process and ensure cross-functional alignment on regional footprint.
- Product Availability: Ensure timely availability of investigational products on site and maintain clinical site accountability records.
- Site Oversight: Perform site oversight visits as planned. Review monitoring visit reports, protocol deviations, and data listings to ensure data quality. Proactively identify and resolve issues.
- Recruitment and Retention: Partner with argenx Site & Patient Engagement, CRO, and other vendors on recruitment and retention tactics. Foster positive relationships with clinical sites and trial personnel. Track patient recruitment.
- Adverse Event Reporting: Ensure timely collection, documentation, and reporting of adverse events (AEs) and serious adverse events (SAEs). Collaborate on report submissions to regulatory authorities.
- Trial Master File Maintenance: Ensure the Trial Master File (TMF) is maintained and up to date.
- Inspection Readiness: Ensure the CTT, CRO, and other vendors operate in a constant state of inspection readiness. Collaborate with Quality to ensure quality oversight of trials. Provide support during audits and inspections.
This comprehensive role requires a proactive approach to managing all aspects of clinical trials, ensuring compliance, and maintaining high standards of quality and efficiency
The Clinical Trial Manager (CTM) will engage in various activities beyond specific trials, including:
- Performance Feedback: Offer feedback on the performance of cross-functional Clinical Trial Team (CTT) members and assist in onboarding new CTMs.
- Innovation and Improvement: Embrace innovative approaches, identify non-value-added activities, and suggest improvements.
- Knowledge Sharing: Share best practices and lessons learned with the team.
- Procedural Input: Provide input on procedures, SOPs, Work Instructions (WIs), and related documents.
- Process Initiatives: Contribute to process improvement initiatives within Trial Operations and participate in cross-functional improvement workstreams.
This role requires a proactive approach to fostering innovation, continuous improvement, and collaboration within the team
- Leadership and Communication: Demonstrates strong leadership abilities and can establish effective working relationships both internally and externally. Possesses excellent interpersonal skills.
- Organizational Skills: Capable of managing multiple tasks and prioritizing workload efficiently.
- Problem-Solving: Skilled in identifying and resolving issues, mitigating risks, and maintaining a comprehensive cross-functional perspective while focusing on details when necessary.
- Communication: Excellent written and verbal communication skills, with the ability to work effectively in a culturally diverse and dynamic global team.
- Regulatory Knowledge: Well-versed in ICH-GCP and other relevant regulations necessary for the successful execution of clinical trials.
- Technical Proficiency: Experienced with various tools and systems used in managing clinical studies, such as MS Project, CTMS, TMF, IWRS, eCOA, and eCRF databases.
- Educational Background: Holds a Bachelor’s or University degree in a medical or para-medical field (e.g., Biology, Biomedical Sciences, Pharmacy, Veterinary) or equivalent experience.
- Professional Experience: At least 5 years of experience in Clinical Operations, including clinical trial management.
- Additional Experience: Experience in the biotech sector is advantageous.
As an employee of Fern Valley you will receive
- an attractive salary in line with your experience and skills
- fringe benefits (including a company car, meal allowance, medical insurance, pension plan, a care plan...)
- a supporting environment throughout your mission with our customer & career planning
- respect for life-work balance
- our commitment towards your professional and personal growth through tailor-made trainings and coaching
Do you want to learn more about Fern Valley? Are you interested in seeing how we can help your company grow? Let's get acquainted. I'll be delighted to hear your story and to share our vision. Experience the personal & open approach of Fern Valley and embark on a journey with us.