Sorry, this job is no longer accepting applications. See below for more jobs that match what you’re looking for!

Clinical Supply Operations Manager

Expired Job

Caresoft Inc. Bernards , NJ 07920

Posted 3 months ago

Job Title: Clinical Supply Operations Manager
Location: Basking Ridge NJ
Duration: 4+ Months

Responsibilities:
Participate in study team meeting, align with study details and collaborate in meeting study objective, Provide supporting information to the teams, in particular RA, RACMC, Clinical ops, and GPMs.
Design packaging requirements; based on a general understanding of the technical aspects of packaging in order to evaluate patient kit design and potential solutions to provide patient friendly designs and support of simplified site dispensing approaches.
Create drug supply forecast for packaging and labeling operations. Support patient study needs that consider enrollment rates, country logistics for shipping and importation, drug expiry, inventory re-supply strategy and the appropriate level of inventory per region.
On-going monitoring of recruitment, drop-out rates and actual supply needs, critical to managing the study needs. Ensure continuous re-assessment of Project needs as recruitment and the study progresses Sourcing of comparators and matching placebo as required on a Project by Project basis.
Drive label generation and approvals, including obtaining translations for all participating countries and the associated regulatory statements. Obtaining cross functional sign off on the labels.
ability to provide budget management for Projects - initial budgets are prepared against available information and a set of assumptions and become more stringent as the study start approaches. Spend against PO's are monitored and extensions justified. Costs saving strategies are employed when appropriate. Invoices are reviewed and approved against targeted budget plans.

Skills Required:
Experience in clinical supply management.
Experience in Project Management, Clinical Supply Management, and/or Pharmaceutical Development required.
Experience in the processes for assimilation and destruction or returned drug supply as well as experience managing third-party contract clinical supply operations required.
Global experience required (member of a team).
Knowledge of cGMPs and GCPs across multiple therapeutic areas and possesses general knowledge of blinding approaches and technologies to support various clinical trial designs (randomized, double-blind, double-dummy, placebo-controlled, cross-over, etc.).
Experienced to manage study needs and possesses the skills and ability to potentially support large phase III Programs. Such characteristics include the ability to evaluate, at times, limited information, to create packaging designs and accurate drug supply forecast.
Experienced in managing third-party contract clinical supply operations. Support the CSO strategy on specific Programs and Projects to support corporate goals and objectives.
Employee should have comprehensive knowledge of IRT design for control of drug dispensing and inventory management.
Knowledge of Import/export regulations, including pro-forma invoice generation, import regulations at a Global level, regulations for IMP QP requirements.
A Bachelors degree in Pharmacy or related field is required.

Please feel free to call at


See if you are a match!

See how well your resume matches up to this job - upload your resume now.

Find your dream job anywhere
with the LiveCareer app.
Download the
LiveCareer app and find
your dream job anywhere
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Senior Manager Clinical Drug Supply & Logistics

Regeneron Pharmaceuticals

Posted 5 days ago

VIEW JOBS 11/9/2018 12:00:00 AM 2019-02-07T00:00 Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases. Summary: 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 Regeneron 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). Duties: Supply Planning * 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) Inventory tracking * Manages and tracks investigational product (IP) inventory; advises supply management team of potential shortages and makes recommendations for resupply activities based on usage trends. Shipments * Oversees IP shipment orders according to supply plans or as requested by 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. IVRS * 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 Regeneron for TMF and inspection readiness. Temperature excursions * 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; communicates with investigator sites, CROs and external vendors to resolve issues. * Authorizes final destruction of drug returns to 3rd party vendor. Expiry Management * Monitors IP expiry data and informs Clinical Supply team and Clinical Trial teams of pending IP expiry. Ancillary Supplies * Develop plans for supplying clinical study sites with ancillary supplies, either through in-house initiated supply or working with supply vendors. Documentation * 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 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. Vendor Management * 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. Staff Management * 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. Process Initiatives * Develop and implement process initiatives in accordance with business needs. Metrics * Develop and evaluate metrics related to drug supply processes and staff. Training * Provide training and development as needed. Reporting * Compiles and reports supply status to study teams and senior management Problem solving * Applies knowledge of company policies and standard practices to resolve problems. Requirements: Bachelor's degree and at least 6 years of relevant experience in the biotechnology/pharmaceutical industry, with 3 years minimum in clinical supply management. Some line management experience, if applicable. 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; Mentoring/coaching 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; Interpersonal skills; Cross functional and cross-cultural awareness; Ability to work in a matrix environment. Success factors: Integrity and Trust Negotiating Dealing with Ambiguity Learning on the Fly Managerial Courage Directing Others Process Management This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business. To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law. Drug supply, logistics, supply chain, distribution, clinical supply, supply manager, clinical logistics #LI-LR1, LMR Regeneron Pharmaceuticals Basking Ridge NJ

Clinical Supply Operations Manager

Expired Job

Caresoft Inc.