Clinical Supplies Job Description
Clinical supplies
provides project management oversight of Project Coordinators, Clinical Trial Assistants, Clinical Research Associates and other clinical study team members;.
Clinical Supplies Duties & Responsibilities
To write an effective clinical supplies job description, begin by listing detailed duties, responsibilities and expectations. We have included clinical supplies job description templates that you can modify and use.
Sample responsibilities for this position include:
Maintains Clinical Supply IMP project binders and product specification files in an “audit-ready” state ensuring inclusion of essential documentation and archiving of interim working notes
Utilizes the Clinical Supplies Management Database suite of software (CSMD) to manage Clinical Supply inventory for projects assigned
Demonstrates proficiency in utilization of appropriate internal Clinical Supply databases, such as the ClinApps suite of software to facilitate the supply and distribution of clinical material to investigators and return from same
Facilitates transfer and reconciliation of returned clinical supply drug from investigational sites using the appropriate internal database software or IRT service
Utilizes the internal database to manage Clinical Supply inventory for projects assigned
Provide direction, leadership, and management to Supply Chain projects
Creating and using spreadsheets and databases for the generation of planning and forecasting presentation materials to be utilized in monthly meetings with cross-functional departments
Interacting with clinical supply leads and other clinical supply stakeholders to obtain and communicate clinical supply timelines
Clinical study and planning data input into Clinapps SmartSupplies system
Manage vendor selection for clinical study support, including Clinical Packaging and Labeling facilities, comparator sourcing and any others as required
Clinical Supplies Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Clinical Supplies
List any licenses or certifications required by the position: IATA, PMP, ISM, APICS
Education for Clinical Supplies
Typically a job would require a certain level of education.
Employers hiring for the clinical supplies job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Master's Degree in Science, Pharmacy, Technical, Education, Life Sciences, Engineering, Business, Nursing, Chemistry, Management
Skills for Clinical Supplies
Desired skills for clinical supplies include:
Clinical Trial Supply process
Project management and Clinical customer relationship building
Project team structure and processes
‘Customers’ team structures and processes
Excel
Microsoft Project
Microsoft Word
Complete clinical supplies life cycle
GMP’s and GCP’s
FDA
Desired experience for clinical supplies includes:
He/she has strong responsibility with respect to the dedicated operational and project budget
He/she will draw from a (global) project team with members out of different disciplines and with different functions that have their contribution to the project realization
For small for large projects, extensive contacts with different suppliers/contractors can be necessary in order to achieve the required project results
Manages complex programs with a moderate level of oversight
Interprets clinical plans and offers CTM solutions to teams
Ensures CTM compliance with applicable regulations and guidelines
Clinical Supplies Examples
1
Clinical Supplies Job Description
Job Description Example
Our growing company is searching for experienced candidates for the position of clinical supplies. 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 supplies
- Review and update existing procedures and SOPs
- Tracking of drug supplies
- Forecasting drug requirements
- Confirm production plans and shipping schedules
- Coordinate the review and approval of provider documentation (distribution instructions, label proofs, packaging specifications and methods, packaging batch records)
- Evaluate emerging trends, technologies, and best practices and provide recommendations
- Lead or participate in primary packaging, secondary packaging and assembly of investigational product (IP) and warehousing activity for domestic and international clinical trials
- Compliance with established procedures, policies, and regulations
- Must become proficient with and employ the departmental computerized inventory system (NASCA) for all packaging activity
- Participate in the training of packaging staff on procedures, equipment operation and SOPs
Qualifications for clinical supplies
- Working knowledge of the contract development / research, pharmaceutical and biotech industries
- Bachelor's degree in a science or related discipline
- 3-5 years in clinical research industry, specifically in the area of Clinical Supplies, Clinical Development, QA/Regulatory Affairs
- Skilled in client and internal team interactions
- Sound understanding of global clinical supply label requirements and regulations
- Experienced in protocol interpretation and packaging and labeling design
2
Clinical Supplies Job Description
Job Description Example
Our growing company is hiring for a clinical supplies. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for clinical supplies
- Arrange study product blinding, provision of code envelopes and unblinding instructions
- Prepare (country-specific) labels, arrange for (re-)labeling of the study products
- Manage the approval (release) process for study products
- Distribution of clinical study products and request for required documentation, import license
- Manage complaints and recall, if applicable
- Coordination of printing Case Report Form and other study-related documents
- Ordering of clinical study supplies
- Maintain information on relevant legal requirements
- Coordinate the selection of, and supervise third parties
- Ensure timely provision of clinical trial material (CTM) for Array sponsored clinical trials and other clinical trials which utilize CTM provided by Array by performing the following activities
Qualifications for clinical supplies
- CGMP, GCP, and ICH knowledge and experience essential
- Familiar with the global drug development processes
- Understanding of drug formulation, analytical method development, stability, and bulk drug manufacturing practices
- Experienced in clinical supplies packaging and labeling design
- Knowledge and experience in managing third party clinical supplies packaging and labeling facilities
- Skilled in client relationship management
3
Clinical Supplies Job Description
Job Description Example
Our company is growing rapidly and is searching for experienced candidates for the position of clinical supplies. 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 supplies
- Forecasting program level and study level needs
- Prepare (country-specific) labels, arrange for (re-)labelling of the study products
- Monitor IP for duration of study and ensuring appropriate stock levels are available for study requirements
- Will manage projects that may reside within single or multiple business lines or sites as assigned
- Preparation and management of a Project Plan to meet required milestones
- Deliver the project within agreed upon timeline and budget
- Provide notification of milestone completions for billing to finance
- Will be primary client communication focal point for project team
- Will be the client advocate
- Will support the training of other PM’s and Project Coordinators within the group
Qualifications for clinical supplies
- Familiarity with various clinical trial designs (randomized, double-blind, double-dummy, placebo-controlled, cross-over)
- Minimum of 9-10 years relevant experience in the pharmaceutical industry or related medical field
- Must work independently under cGMPs and SOPs
- Proven interpersonal skills strong oral and written communication skills
- Bachelor’s degree in Business Administration and/or Finance, and strong analytical and numerical skills
- A strong advantage will be GCP/GMP/ Finance Training
4
Clinical Supplies Job Description
Job Description Example
Our company is growing rapidly and is searching for experienced candidates for the position of clinical supplies. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for clinical supplies
- Will be proficient in technical aspects of PM related software used by site
- Provide input to (Interactive Response Technology) IRT specification design
- Advises and supports the application and integration of Sourcing Category Management (SCM), and techniques to meet the needs of Research & Development and Global Product Development and Supply for the Clinical Supplies category
- This individual is responsible for leading the sourcing, negotiating, contracting, purchasing to leverage buying power and recommend appropriate Procurement strategies and tactics to obtain desired results
- Extensive interaction with Business Partners is required to ensure that total costs are identified and optimal savings are realized in the execution of contracts
- Manage Strategic category Management processes, procedures, supplier and category segmentation, metrics/KPI development and application, scorecard format, contract management, This position will facilitate continuous improvement and ideation that will enable the Business Partner, Category and Functional Leads to achieve strategic objectives
- Apply appropriate methods of procurement
- Perform cost benefit analysis on planned acquisitions
- Develop and review specifications, statements of work, performance terms, and/or acceptance criteria
- Locate and select potential sources of materials and/or services
Qualifications for clinical supplies
- 4 years relevant clinical research/GMP experience
- Thorough understanding of global drug development and the clinical trial project management process, with a special emphasis on investigator sites, patient recruitment and retention
- Thorough and practical working knowledge of ICH-GCP Guidelines, Clinical GMP, including relevant international requirements/guidelines for the conduct of global clinical development programs
- Familiar with ICH-GCP guidelines, Good Distribution Practices, Good Manufacturing Practices Annex 9
- Practical, systematic, and has an efficient working attitude
- Able to set priorities in case of urgent requests or complex situations
5
Clinical Supplies Job Description
Job Description Example
Our innovative and growing company is looking to fill the role of clinical supplies. 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 supplies
- Evaluate competitive offerings to determine the overall best offer for goods or services
- Negotiate and/or issue contracts and purchase orders, obtaining legal review and approval of a contract when required
- Administer contracts and purchase orders from award to completion
- Resolve contract and purchase order differences with suppliers
- Resolve complex payment problems with supplier and user departments
- Review and revise procurement practices to ensure their conformance with established laws
- Represents clinical supplies function at clinical trial team meetings
- Maintains required documents in a manner consistent with cGMP, 21 CFR Part 11, Annex 13 internal QM, Corporate and Functional level SOPs
- Meet or exceed the sales goal for the assigned accounts and territory Romandie, France and Benelux
- Document activity and report progress on an ongoing basis with CRM systems that are provided
Qualifications for clinical supplies
- Excellent communication skills to interact with the internal multidisciplinary project team, with external partners such as production locations, suppliers and couriers, and other (logistic) service providers
- Must have knowledge and experience in working with IVW/RS, especially with respect to supply management and patient randomization
- Graduate from any discipline
- Project based IT systems Visio
- Good (IT) application know- how
- Track record of working in interdisciplinary and cross-cultural teams