The Senior Manager, Clinical Logistics is responsible for forecasting Investigational Product (IP) supply requirements for multiple clinical trials and for managing the IP distribution process to one or more clinical trials. Activities are performed on time, within budget and with good quality, in compliance with Regulatory Authorities’ regulations/guidelines and SOPs / WPDs. Contributes and drives ongoing process improvement initiatives. This role applies to internally sourced studies and/or CRO/Partnered studies. Collaborates and interacts with clinical trial managers, therapeutic area project managers, medical monitors, as well as staff from quality, clinical compliance, regulatory, formulations, and IOPS (CMC, external manufacturing, stability).
Serves as lead logistics manager for the functional area in supply planning, including demand forecasting according to IOPS requirements; Manages supply planning and timelines to ensure alignment with study plans and timelines and overall clinical development plan; Works with clinical logistics management to determine resourcing needs; Provides input to the development of IP-related study documents including protocols, study and pharmacy manuals; Responsible for working within established timelines of investigational product manufacturing, labeling, release, distribution and return/destruction, and/or helping to establish these timelines; Oversees setup and management of IVRS (IWRS)
Manages and tracks investigational product (IP) inventory; advises supply management team of potential shortages and makes recommendations for resupply activities based on usage trends.
Oversees IP shipment orders according to supply plans or as requested by the Clinical Trial Management team, to ensure timely and compliant shipment and delivery to investigator sites. Works with Clinical Logistics Associate to complete this activity and/or manages any/all aspects of the process.
Extensive knowledge and experience with Interactive Response Technologies (IRT) such as IVRS and IWRS; Work with cross-functional teams to develop specifications and user testing of IRT systems provided by 3rd party vendors. Lead effort for clinical supply management functionality; Monitor and manage clinical supply activities through IRT from study start-up through study closure; Ensure appropriate system documentation is transferred to TMF and inspection readiness.
Reviews and evaluates temperature excursion data and communicates stability information to clinical trial managers, CROs, and investigator sites; provides assessments to supply management team regarding excursion trends in each study.
Returns & Destruction
Reviews drug return and destruction records; communicate with investigator sites, CROs and external vendors to resolve issues.
Authorizes final destruction of drug returns to 3rd party vendor.
Monitors IP expiry data and informs Clinical Supply team and Clinical Trial teams of pending IP expiry.
Develop plans for supplying clinical study sites with ancillary supplies, either through in-house initiated supply or working with supply vendors.
Ensures appropriate documentation of IP supply activities is provided to clinical trial teams for the Trial Master File. Provides input to drug kit randomization specifications and reviews and master kit lists; Reviews IVRS specs and reviews IVRS user manuals; Designs, reviews and approves IP-related study tools (for clinical study teams and investigative site use), as needed. Supports the inspection team in preparation for and during regulatory agency inspection.
Study Team Interaction
Represents Clinical Logistics/Supply Management on cross-functional study team (s) and/or sub-team(s); Provides input into budgets, SoWs, contracts and timelines for IP-related services; Prepares or provides input into IP-related content for training materials and coordinates training on study procedures; In collaboration with the CTM for study, provides input into IP-related study specific working practices; Establishes study team contacts, roles, responsibilities, and objectives for IP-related services; Develops, manages, and maintains relationships with external partners; Effectively communicates with CROs, shipping and IVRS vendors, study sites and study team members to ensure ongoing successful execution; Acts as point of escalation for IP-related issues.
Leads management of IP service vendors (performance, quality, timelines, deliverables, costs); Participates in preparation of RFP, assumptions and SOW for CROs and IP services vendors (labeling, packaging, distribution; IVRS/IWRS); Provides input, reviews, and approves vendor study specifications; Serves as point of escalation for vendor-related IP issues as they arise; Reviews and approves/scrutinizes specified costs on vendor invoices against contract, as delegated; Recommends vendors to IOPS and Clinical Study Teams.
May or may not supervise staff. If supervising staff, manage staff's daily activities to implement plans, as appropriate.
May mentor or coach junior Clinical Logistics staff.
Develop and implement process initiatives in accordance with business needs.
Develop and evaluate metrics related to drug supply processes and staff.
Provide training and development as needed.
Compiles and reports supply status to study teams and senior management
Applies knowledge of company policies and standard practices to resolve problems.
Experience And Required Skills :
Experience developing trial drug supply plans
Investigational Product forecasting skills
Working knowledge of the clinical drug development process and clinical trial methodology;
Knowledge of ICH/GCP and regulatory guidelines/directives
Disease/therapeutic area knowledge (a plus)
Understands current and future business trends and information
Leadership and negotiation skills
Ability to effectively multi-task and prioritize
Effective problem-solving skills
Written and verbal communication and presentation skills in small and large group settings
Project management and organizational skills
Computer skills, with competency in MS Word, Excel
Study Tools including electronic system skills IVRS/IWRS, CTMS, EDC
Cross-functional and cross-cultural awareness
Ability to work in a matrix environment.
Integrity and Trust
Dealing with Ambiguity
Learning on the Fly
Minimum of 6 years of relevant experience in the biotechnology/pharmaceutical industry, with 3 years minimum in clinical supply management.
Some line management experience, if applicable.
Our Client EBP is the most versatile family-owned distribution partner that provides a broad range of essential supplies & services for progressive commercial organizations throughout the eastern and domestic United States.
Since 1918, our Client has strengthened your ability to go forward – by making your supplies work harder and helping you work smarter.
As they head into a second century of business, the expert thinking, top brands, service and training you depend on are being expanded. A new Training Academy, an expanded ecommerce experience and new innovations from partners in the industry.