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Sr Clinical Trial Manager, FSP

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Thermo Fisher Scientific

1mo ago

  • Job
    Full-time
    Mid Level
  • Healthcare
  • Milan

AI generated summary

  • You need a relevant degree, 4+ years in clinical trial management, strong leadership, organizational skills, problem-solving ability, ICH-GCP knowledge, and experience with clinical study tools.
  • You will lead cross-functional trial teams, manage CRO/Vendor relations, ensure compliance, oversee study progress, and enhance patient experience while maintaining quality and budget controls.

Requirements

  • Bachelor’s degree or University degree – medical or para-medical (Biology, Biomedical Sciences, Pharmacy, Veterinary, etc.) or equivalent by experience.
  • Minimum of 4 years experience in global Clinical Trial Management roles
  • Biotech experience is a plus.
  • Rare disease, Auto-immune, and/or oncology clinical trial background is a plus.
  • Leadership qualities and ability to establish good and effective internal and external working relationships and communication. Good interpersonal skills.
  • Good organizational skills to manage multiple varied tasks and prioritize workload.
  • Problem-solving skills with ability to identify and resolve issues, identify and mitigate risks. Able to maintain a holistic cross-functional view while diving into details as needed.
  • Good written and verbal communication skills, acting globally in a culturally diverse dynamic team.
  • Knowledge of ICH-GCP and other applicable regulations to successfully execute clinical trials.
  • Experience with tools and systems for managing clinical studies (MS Project, CTMS, TMF, IWRS, eCOA, eCRF databases, etc).

Responsibilities

  • If applicable, establish and lead the cross-functional CTT in partnership with the Lead Trial Physician. Work with functional leaders to assign CTT representatives from involved functional areas.
  • Ensure clinical trials are executed according to protocol requirements, trial plans, OGSM, client procedures, ICH-GCP, and other applicable regulations. Communicate in a transparent, clear way, and collaborate with CTT members & external partners to achieve clinical trial objectives.
  • Oversee cross-functional planning, track study progress, and proactively manage completion of trial deliverables and milestones.
  • Responsible for leading, guiding, and overseeing CROs and other vendors to ensure contractual obligations are met according to plan and metrics.
  • Manage CTT risk identification & mitigations, suggest and collaborate on solutions, manage contingency planning, and oversee implementation. Manage the implementation of corrective and preventative actions as needed. Maintain awareness of risks or issues that could have cross-indication, cross-franchise, or cross-asset impact and escalate to the (Franchise) CODL, Head of Trial Operations, and/or Senior Management as needed.
  • Contribute to the evaluation, selection, and contracting of CROs and vendors. Ensure scope of work aligns with protocol requirements and established budget and timelines. Oversee contract management and ensure services are delivered per contract. Ensure accurate trial budget management, timely management of scope changes, and budget reconciliations.
  • Ensure CTT members, including CRO and vendor teams, receive appropriate trial-specific training for their function. Oversee setup, coordination, and conduct of Investigator Meetings.
  • Develop and/or contribute to trial-related materials such as the clinical protocol, study training materials, pharmacy manual, clinical monitoring plans, data management plan, eCRF and associated completion guidelines, patient information and informed consent, site instructions for specimen collection, patient recruitment and retention materials, etc.
  • Act with the mindset of reducing patient & site burden throughout the trial.
  • Ensure vendor systems and processes are configured according to protocol requirements & applicable regulations and implemented within established timelines. Contribute to the development and approval of project specifications, user acceptance testing, implementation, and change management.
  • Oversee the country and site feasibility process, ensure cross-functional alignment on regional footprint.
  • Ensure timely availability of investigational product on site and ensure clinical site accountability records are in place and maintained.
  • Perform site oversight visits according to plan. Review monitoring visit reports, protocol deviations, and data listings to ensure reliable quality data are delivered. Monitor data quality, completeness, and timeliness. Proactively identify and manage resolution of issues/concerns.
  • Partner with client Site & Patient Engagement, CRO, and other vendors on recruitment & retention tactics that engage patients & sites and foster positive experiences. Ensure supportive relationships with clinical sites & trial personnel. Oversee and track patient recruitment.
  • Ensure timely collection, documentation, and reporting of adverse events (AEs) and serious adverse events (SAEs) and collaborate in the submission of reports to regulatory authorities.
  • Ensure the Trial Master File (TMF) is maintained and up to date.
  • Ensure the CTT, CRO, and other vendors operate in a constant state of inspection readiness. Collaborate with Quality to ensure quality oversight of assigned trials utilizing available tools. Provides support during audits & inspections for assigned trials.
  • Provide feedback on the performance of cross-functional CTT members. Assist with onboarding new CTMs.
  • Embrace innovation. Recognize non-value-added activities and propose opportunities for improvement.
  • Share best practices & learnings.
  • Provide input to procedures, SOPs, WIs, and related documents.
  • Contribute to process initiatives within Trial Operations. Contribute to cross-functional improvement workstreams.

FAQs

What is the work schedule for the Sr Clinical Trial Manager position?

The work schedule is standard, from Monday to Friday.

What are the environmental conditions for this role?

The role is office-based.

What is the main responsibility of a Clinical Trial Manager (CTM)?

The CTM is responsible for the global operational deliverables of clinical studies from the Final Protocol Concept Sheet to the Clinical Study Report (CSR), ensuring trials are executed according to protocol requirements, timelines, budgets, and regulatory standards.

Does the CTM manage external partners?

Yes, the CTM oversees external partners, including CROs and vendors, to ensure contractual obligations are met according to the study plan.

What experience is required for this position?

A minimum of 4 years of experience in global Clinical Trial Management roles is required. Experience in biotech and backgrounds in rare disease, auto-immune, and/or oncology clinical trials are considered a plus.

What educational background is preferred for this position?

A Bachelor’s degree or University degree in a medical or para-medical field (such as Biology, Biomedical Sciences, Pharmacy, Veterinary, etc.) or equivalent experience is preferred.

What skills and competencies are essential for the CTM role?

Essential skills and competencies include leadership qualities, good organizational and problem-solving skills, effective communication, knowledge of ICH-GCP and applicable regulations, and proficiency in tools and systems for managing clinical studies.

Is participation in activities outside of trial-specific responsibilities expected?

Yes, the CTM will participate in other activities such as providing feedback on team performance, embracing innovation, sharing best practices, and contributing to process improvements.

What does "Operational Voice" mean in the context of the CTM's role?

The "Operational Voice" refers to the CTM serving as the main point of operational expertise for assigned studies, communicating internally and externally to ensure clinical trial objectives are met.

Are there opportunities for professional growth within the position?

Yes, the CTM will have opportunities for professional growth by participating in cross-functional initiatives, contributing to process initiatives within Trial Operations, and assisting with the onboarding of new CTMs.

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Thermo Fisher Scientific

The World Leader In Serving Science

Science & Healthcare
Industry
10,001+
Employees

Mission & Purpose

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.