As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
Job Purpose: Clinical Trial Site Manager (CTSM) aka Clinical Supplies Project Manager The CTSM is the single point of contact for the study team (Central & LOC’s).
The CTSM is accountable for the set-up and follow-up of the logistical activities from the initiation of a draft concept protocol until the product delivery to the final depot.
This includes:
the translation of study protocols into an operational demand the feasibility assessment for completion of logistical activities the definition of the logistic operational strategies (supply, distribution, randomization) the set-up & follow-up of clinical supply related activities for a project or a group of studies
the guaranty of alignment among the network of stakeholders, GMP operations and clinical operations (Central and Local) to support the delivery of clinical vaccines and ancillaries in time at right quality and within agreed budget
The scope of work includes project management, leadership, and oversight of both global and in-country activities, as well as authorship of some study documents.
Key Responsibilities
For a project or a group of studies covering different projects, ensure effective interface between CSC and Clinical Study Team including the Study Delivery Lead, Local Delivery Lead, Label expert, pack-expert, depot and Distribution expert and their related quality partners, by providing input in study protocol, provide logistic instructions for investigational sites, informing about logistic requirements and due dates, supply issues.
Be the Clinical Study Team voice within CSC to communicate needs and constraints in terms of logistic supply management & logistic support.
Provide input in development of the study protocol and related documents.
Establish operational feasibility of each new study protocol and escalate detected feasibility issues at both Clinical Study team, Clinical Supply Operations and Portfolio Manager (PFM).
Report newly planned studies and new demand in ongoing studies to planning team to ensure capacity feasibility is done.
For each study, define the operational set-up in order to align flows, operational strategies and activities (label creation, label/pack warehouse & distribution), ensure alignment with the other stakeholder’s constraints and develops study logistical plan and including detailed schedule and budget.
Own the supply chain processes and documents. Ensure that all study related activities are operationally set-up and conducted in CSC in line with the approach agreed with the study team.
Manage and set-up the collaboration with the world-wide depots selected for the clinical study in line with the local requirements defined with the countries involved in the study.
Study follow-up and guarantee study continuity by ensuring vaccine re-supplies are done in time according to the recruitment strategy and changing needs of the studies and countries.
Ensure study milestones are respected by Clinical Supply Operations based on the planning information provided by the Production planner.
Acts as the single point of contact for review of study timings and to (re)negotiate due dates.
Follow up on study KPIs, identify trends and ensure problems are addressed.
Act as Subject Matter Expert for one or several processes of the team. Ensure standard processes a and ways of working are in place across all project and studies for all key activities of CTSMs.
Develop and maintain the appropriate documentation (SOPs, WIKI, guidance, training material to support operations) related to logistic processes, study management and the interface with other stakeholders.
Accountable for inspection readiness, including documentation of all relevant communications, s strategic decision in eTMF/ Veeva.
REQUIREMENTS:
Bachelor's Degree required, no prior experience required in project management or coordination
Preferred Fields of Study: Chemistry, Biology, Engineering, Business, or related discipline
Additional certifications in Project Management are valued but not required
Strong proficiency in Microsoft Office Suite, particularly Excel, PowerPoint, and Project
Excellent organizational and time management skills with ability to handle multiple projects simultaneously
Outstanding written and verbal communication skills
Detail-oriented with strong documentation and process management capabilities
Experience with quality systems and GMP compliance preferred
Ability to work independently while collaborating effectively with cross-functional teams
Strong analytical and problem-solving skills
Proficiency in English required; additional languages may be needed based on location
Experience with project management software and tools
Ability to identify and mitigate risks while maintaining project timelines
Strong customer service orientation with excellent interpersonal skills
Flexibility to adapt to changing priorities and deadlines
Understanding of relevant industry regulations and standards
Experience in pharmaceutical, healthcare, or scientific industries preferred
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