Clinical Supply Chain Job Description
Clinical supply chain
provides programming, process/technology development and implementation and clinical trial expertise and regulatory experience to the R&D organization.
Clinical Supply Chain Duties & Responsibilities
To write an effective clinical supply chain job description, begin by listing detailed duties, responsibilities and expectations. We have included clinical supply chain job description templates that you can modify and use.
Sample responsibilities for this position include:
In partnership with key stakeholders from Clinical Operations, Medical, Quality and Regulatory oversee the development of a Clinical Supply Plan that documents the study design, product requirements, and study assumptions enrollment, target countries, number of sites, for each study included in a Clinical Program
Partner with Clinical Operations to identify demand assumptions, such as enrollment rate, number of sites, number of countries
Monitor inventory levels at depots and clinical sites through the life of a trial
Manage drug returns process and site close-out activities
Communicate with external service providers on project requirements
Develop clinical trial material supply strategies to meet the needs of IDTA clinical trials programs
Creation of study-specific procedures and forms for IMP activities
Assess clinical study recruitment rates and ensure supply planning is adopted accordingly
Organize Pack, Labeling and Distribution planning
Utilize business tools to manage inventories at depots and sites and ensure on-time delivery with minimal overage of clinical supplies
Clinical Supply Chain Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Clinical Supply Chain
List any licenses or certifications required by the position: APICS, CPIM, PMP, CIRM, CILT, CMIS, CSCP, FPX, ISM
Education for Clinical Supply Chain
Typically a job would require a certain level of education.
Employers hiring for the clinical supply chain job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Associate Degree in Science, Operations Management, Business, Engineering, Supply Chain Management, Nursing, Life Science, Business/Administration, Life Sciences, Management
Skills for Clinical Supply Chain
Desired skills for clinical supply chain include:
Microsoft Excel
Regulatory requirements
GMP
GCP
GCPs
Relevant cGMPs
Clinical Trial Directive and global regulatory environment impacting the provision of investigational products
Clinical Development processes relevant to investigational products
R&D supply chain and drug development process
Improve forecast quality
Desired experience for clinical supply chain includes:
Conduct issue resolution activities for supply aspects of clinical studies (e.g., packaging, distribution)
Establish and modify trial specific distribution agreements
Develop internal collaboration with stakeholders in Clinical Research and CM&C to ensure customer satisfaction
Interface with Service Provider team members, such as CRO Trial Managers, packaging/labeling/distribution and IVRS project managers
Manage trial supply budget
Develop working relationships within parent company Supply Management groups
Clinical Supply Chain Examples
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Clinical Supply Chain Job Description
Job Description Example
Our company is growing rapidly and is looking for a clinical supply chain. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for clinical supply chain
- Develop and maintain clinical inventory demand forecasts and clinical inventory management plans throughout the clinical trial lifecycle, including ongoing assessment of trial performance against projections and current device inventory position against supply, timeline and product shelf life
- Partner with divisional/regional supply chain professionals to regularly integrate clinical inventory information into the overall supply and demand planning for the applicable product line
- Engage with internal and external groups/vendors to ensure distribution and tracking capabilities are in place to support on-time study start up
- Oversee device accountability metrics to ensure investigational devices are tracked and disposition is monitored throughout the clinical trial lifecycle
- Collaborate with internal and external groups to facilitate and track return of investigational product
- Complete ongoing device reconciliation activities and identify and monitor any study-specific device management risks
- Support Vendor Management activities for existing and new trials
- Support regulatory reporting and compliance auditing
- Escalate issues and potential risks to management as applicable
- Create, track and manage quality records as required
Qualifications for clinical supply chain
- Supply chain certification
- Medical devices/pharmaceutical, clinical trials, and/or device distribution experience preferred
- Advanced data analysis skills with ability to structure and perform data analytics in Excel
- Experience utilizing SAP or other ERP system preferred
- Co-Facilitates w/Dir of MM all Clinical Committees and coordinate activities as appropriate
- Interacts with clinical staff to ensure appropriate feedback is received before product decisions are made
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Clinical Supply Chain Job Description
Job Description Example
Our company is growing rapidly and is looking to fill the role of clinical supply chain. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for clinical supply chain
- Interacts with applicable departments to assure all safety, regulatory and epidemiology issues are addressed prior to product selection
- Serves as facilitator and clinical resource manager for all clinicians and physicians for new product introduction process to include supplies, services, technology, medical devices and capital equipment as requested
- Evaluates and prioritizes service line standardization and utilization opportunities using information obtained via the committee meetings and Med-Approve software, hospital financial and operational systems and discussions with administrative leadership, physicians and staff
- Analyzes cost saving ideas and implement opportunities for standardization
- Helps implement the new Med-Approve system within FHHMC, Lake Placid & Wauchula which will enable the region to maintain a detailed cost savings tracking system
- Provides current literature related to recommendations that will assist end-users in the development of data-driven decisions and evidence-based practice
- Responsible for managing the distribution of products to ensure maximum efficiency, quality and customer service at the least possible cost
- Oversees activities of those engaged in the receiving, storing, controlling and delivering of materials
- Assists in Human Resources functions for assigned staff including the hiring of responsible personnel
- Complete evaluations and make recommendations on disciplinary actions
Qualifications for clinical supply chain
- Trains new hires and assigns work duties and schedules
- Assures department coverage
- Assumes responsibility for the aesthetics, and cleanliness of the central storeroom
- Ensures a safe environment for storeroom and enforces safety procedures for staff
- Current Florida RN license, BSN degree required
- Job requires relationship building, Project management skills and team leadership skills required
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Clinical Supply Chain Job Description
Job Description Example
Our innovative and growing company is searching for experienced candidates for the position of clinical supply chain. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for clinical supply chain
- Requires analytical ability to identify cost savings opportunities, formulate alternative solutions, develop cost models, determine clinical/end user acceptability and assist in the design and development of systems
- Requires strong interpersonal and communication (oral, written, and presentation) skills to persuade and guide the decision process
- Supervise process design activities
- Assist with the development of capabilities and key performance measurements/KPI's
- Develop and implement tracking and reporting tools for monitoring actual to proposed improvements
- Facilitate and support the use of value analysis processes to identify and implement value creation opportunities for clients
- Prepare the client for implementation (planning, tools, communications, training and measurement)
- Daily par level replenishment of Nursing units, MOB, & Out Patient clean supply rooms
- Follows proper techniques while working in Clinical Supply to adhere to OSHA requirements and properly store and rotate medical supplies to maintain proper rotation and shelf life
- Initiates medical supply items needed for Clinical Supply inventory on the “Preliminary Order” worksheet
Qualifications for clinical supply chain
- Sets future direction and strategy for the management of projects and program for own direct reports and across multiple portfolios
- Experience working within a cGMP supply chain environment is essential
- Minimum of 4 years relevant clinical research experience with at least 2 years’ experience in clinical supply distribution
- Experience in end to end clinical trial management, ideally with global project management experience
- Experience developing effective strategies to bring about trial success using an evidence-based approach
- Must have considerable knowledge (breadth and depth) in the management of clinical trial supplies including, but not limited to planning, forecasting, clinical packaging
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Clinical Supply Chain Job Description
Job Description Example
Our innovative and growing company is looking for a clinical supply chain. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for clinical supply chain
- Participates in in-services, continuing education and staff meetings
- May lead and/or will participate on teams comprised of customers, suppliers, and/or members of Purchasing, IVRS, Distribution and Packaging to review the clinical study protocol requirements and establish a project plan and timeline
- Works with both internal and client Project teams to ensure consistent communication of ancillary material supply status
- Implements and monitors inventory management plans that may have complex supply chains
- Expertly identify and communicate both operational and strategic supply risks to management
- Apply understanding of clinical regulatory environment, packaging and label development
- The incumbent will manage operation execution, write and review departmental procedures appropriate to his/her area of responsibility, track and adhere to departmental budgets, oversee inventory procurement, conduct production tracking, manage material movement activity, KPI tracking and reporting
- Coordinate review and approval of labels with stakeholders
- The CSC Trial manager is responsible to define optimal shipment plan with clinical counterpart and for follow-up of shipping activities so that clinical sites never run out of product
- The CSC Trial manager is responsible for coordination of reconciliation effort and delivery of global reconciliation report
Qualifications for clinical supply chain
- Develops an area of specialist expertise such as therapeutic area knowledge
- Knowledge and Understanding of the drug development process and demonstrated experience with clinical study processes, manufacturing and packaging
- Direct experience of project management, and inventory management
- Demonstrated ability of working in a matrix environment and balanced with an ability to establish plans and drive for results
- Problem solving abilities suitable for handling the complex issues associated with global supply problems
- Demonstrated ability & flexibility to work with aggressive and changing timelines and with limited information and without defined absolutes
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Clinical Supply Chain Job Description
Job Description Example
Our company is growing rapidly and is hiring for a clinical supply chain. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for clinical supply chain
- The CSC Trial manager is responsible to for quality control of documentation archival of trial supply documentation in accordance to trial master file requirements
- Lead forecasting efforts, including key stakeholder meetings, to ensure the adequacy of supply/re-supply strategies and negotiate resolution of resource conflicts where necessary
- Actively participate in planning meetings to ensure that project needs, priorities, and timing are understood
- Facilitate the retrieval of Import Permits if required
- Ensure Regulatory “green light” “technical green light”
- Coordinates with Nursing Leadership the re-ordering, re-stocking, and reconciliation of discrepancies of the supplies/implants based upon established par levels and consignment agreement
- Responsible for initiating consignment agreements with Sourcing for high value, high use items
- The Materials Planner’s primarily responsible will be to work alongside the Senior Planners to support material planning for the Devens Commercial and Clinical Manufacturing facility
- The material planner will assist in executing materials planning and coordinating the overall supply chain activities supporting clinical product tech transfers into Devens
- Creates and releases process orders in SAP system according to schedule
Qualifications for clinical supply chain
- Knowledge of the packaging industry and technical challenges with regards to packaging and labeling
- Knowledge of API/Manufacturing and technical challenges with regards to primary and secondary manufacturing
- Lean Sigma training/Experience
- A minimum of 3 years relevant supply chain/sourcing/procurement/contract negotiation and administration within a hospital/health system or healthcare consulting firm setting
- Willingness and ability to travel every week (Monday-Thursday)
- A Master�s degree in Business Administration, Health or Hospital Administration is highly desirable