Job Title: Clinical Trial Supplies Manager Location: Local to FL, Remote Duration: 6 Months
100 % remote Manager prefers local candidates (will consider non local candidates as well) Required bachelor's degree Must Haves: Phase 1 to 4 clinical trial experience Managing end to end supply chain
This position is responsible for the supply planning and inventory management of clinical supplies required to support global clinical research and development studies during phases 1-4. The individual must partner closely with clinical, regulatory, quality and production associates to ensure timely delivery of supplies to study participants. • Collaborating with internal and external Customers and Service Providers, including but not limited to Clinical Research and Development, Global Study Management and Monitoring (GSMM), Project Management, client Affiliates, Medical Affairs (MA), Regulatory, CMC, QA, Packaging Vendors, CRO’s, IRT Organizations, and Global Clinical Supply Chain Functional Operations to ensure all needs are met. • Working with teams for optimal use of the investigational material supply chain to achieve study and corporate goals. • Identifying and supporting strategies for continuous improvement and departmental and/or inter-departmental projects. • Co-creating clinical and development timelines and directly responsible for communicating timelines and investigational product strategies to Study Teams as well as cross-functional teams. • Proactively defining, planning, and communicating clinical supply strategy in support of global clinical studies, as well as monitoring and reacting to unforeseen clinical demand changes. • Developing supply forecasts through evaluation of the clinical development plan and protocol analysis. • Reviewing and providing input for draft medical protocols to develop packaging and labelling configurations and create packaging specifications in collaboration with Clinical Operations partners. • Collaborating with Global Clinical Supply Chain functions and external Vendors on the package design and label development for investigational product to meet all protocol and regulatory requirements. • Monitoring long-term inventory and allocation strategies considering drug recertification, country specific regulatory requirements, international drug shipment and overall demand. • Performing analytical assessments of drug utilization as it pertains to current forecasts versus inventories and creating product orders as needed. • Working with third party vendors to ensure the timely, efficient, high quality, cost effective execution of all outsourced clinical supply activities. • Ensuring releasable supplies for all assigned compounds and Protocols considering country Regulatory and QP Release documentation and requirements. • Initiating, reviewing and approving IRT specifications. Participating in user acceptance testing. • Developing investigational product distribution strategies maintaining distribution and supply strategy at depot and site level according to study (and IRT) requirements. • Actively participating in Trial Supplies Management Functional team, Study Team, Country Medical Affairs Affiliate & CSC Matrix Team Meetings providing all relevant data and documentation prior to each meeting, highlighting any risks and mitigation required. • Actively supports the CSC Budget Process. • Acting as the main Clinical Supplies contact person for the assigned Compound and associated studies, lead communications regarding global supply strategy with Study Team or Country Affiliate Medical Affairs team as appropriate. • Proactively identifying strategic and operational issues and develop proposals outlining solutions. • Managing conflicts / issues with internal and external partners and customers. • Demonstrating strong knowledge when presenting clinical supply processes at cross-functional meetings and actively participates. • Ability to coach new Trial Supply Managers on individual tasks. • Participating in training efforts for external functions on clinical supply processes to facilitate improved cross-functional relationships. • Speaking at Investigator Meetings as required. • Traveling as required (<10%). • Writing of / input to departmental SOPs. • Performs other tasks as assigned. Required: • Moderate / Strong knowledge of the global drug development process and global regulatory requirements. • Proficient and strong analytical skills. • Strong communication and negotiation skills. • Proficient and strong Project management skills. • Strong knowledge of Forecasting and Planning and proficient knowledge of related areas, i.e. Manufacturing, Packaging & Labelling, IRT, Logistics, Quality, Stability, etc. • Proficient knowledge of import / export requirements. • Proficient/Strong knowledge of IRT and CTMS systems. • Proficient / Strong knowledge of industry technology. • Applies and drives Forecasting and Planning activity as it relates to protocol. • Ability to build/drive internal team consensus. • Translates broad strategies into specific objectives and action plans. • Team and individual leadership (lead courageously). • Oral and written communication (fosters open communication). • Conflict resolution (manages disagreements). • Negotiation (Manages Execution, Results Driven, Analysis of Issues, Effective Speaking, Builds Relationships).
Ideal Candidates Would Also Have: • Coaching and mentoring (fosters teamwork).
Other Qualifications: • Bachelor’s degree required. • 2 years of relevant work experience required, preferably in a pharmaceutical environment. • An equivalent combination of education and experience may substitute. As a key partner to many functions within the clinical supply chain and the broader research and development business this opportunity provides access to a wealth of learning and development possibilities within the pharmaceutical business.Position is offered by a no fee agency. Location : 0000, no name, Other, United States, 00000 About Us: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at: http://www.spectraforce.com
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.
Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation. At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $74.00/hr.
