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

Sr. Clinical Supplies

Expired Job

Medfocus Madison , NJ 07940

Posted 3 months ago

Independently coordinates clinical supply activities for clinical studies in support of development programs. These activities include review of clinical study protocols, design of clinical labels, preparation of packaging and labelling contracts, and forecasting and ordering supplies. Must coordinate the efforts of Clinical Trial Supplies Packaging with Clinical Supplies Manufacturing, Clinical Research, Pharmaceutical Development, Quality Assurance, and Regulatory Affairs with the objective of establishing a plan to have clinical supplies available within the agreed time frame.

The employee must conduct their work activities in compliance with all relevant laws, regulations, and regulatory guidelines as well as all Company policies and procedures.
Key Duties / Responsibilities
Role: Develops and implements the initial timeline, budget, drug supply forecasts and component requirements needed for preparation of the Clinical Supply Master Plan for Phase I through IV clinical protocols Oversight: No oversight

  • Effectively organizes and conducts meetings, and demonstrates facilitation and listening skills

  • Consistently demonstrates skills for evaluating customer needs and offering alternatives to accomplish project goals

  • Represent GCSM at CMC/Clinical meetings to update and forecast the status of projects

  • Reviews Clinical Research Development programs and coordinates development of yearly clinical supplies forecasts and supply plans

  • Protocol interpretation and breakdown

  • Demonstrates planning, project management, negotiation and presentation skills

Role: Monitor IP for duration of study and ensuring appropriate stock levels are available for study requirements. Continue to monitor budget, depots and monitor IRT after study start. Ensure IP reconciliation is completed.

  • Works on routine assignments, and applies knowledge and experience in learning new procedures

  • Report and Protocol Writing: Create reports and documents to facilitate and record every aspect of the operations performed or projected

  • Effective coordination of supply requirements for local and international studies, including continuous forecasting, communicating manufacturing needs, and scheduling of packaging/labelling activities

  • Demonstrates a comprehensive understanding and knowledge of the Investigational Product Supply Chain

  • Ability to handle multiple assignments and priorities simultaneously in a fluid environment with time pressures

  • Demonstrates a comprehensive understanding and is knowledgeable in development of Clinical Supplies IRT requirements for drug supply management

  • Sound judgement, analytical, problem solving and decision-making skills

Role: Demonstrates a comprehensive understanding and is knowledgeable in regulatory requirements, including GMPs and GCPs

  • Review and update existing SOPs and identify the need for and assist in the establishment of new departmental procedures

  • Demonstrates a comprehensive understanding of the drug development process and requirements of IND/NDA submissions

Minimum Requirements

Bachelors Degree
At least 6+ years of Clinical Supply / Clinical Packaging / Project Coordination experience in the pharmaceutical/device industry or CRO

  • Knowledge cGMPs and relevant FDA Regulations essential

  • Excellent communication and writing skills

  • Proficiency in Microsoft Office and Microsoft Project

  • High level of professionalism

  • Ability to prioritize, planning and problem-solving

  • Ability to handle multiple projects and work in a team environment

  • Ability to operate, with composure and confidence, in a team or matrix environment

  • Effective influencing skills

Ability to travel up to 10% of time

Please send resume to

  • Min Salary:* $0.00

Max Salary: $0.00

City: Madison

  • State:* NJ
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

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
Clinical Programmer Analyst Sr


Posted 2 weeks ago

VIEW JOBS 11/1/2018 12:06:46 AM 2019-01-30T00:06 <p>NOTE- Please note, do not send SAS programmers CV across. This is not a SAS programming position. We are interested in individuals with 3+ years of clinical experience and who have worked with vendors. <br /> <br /> Responsible for leading internal and outsourced Clinical Programming activities in support of Clinical Research studies and managing the design, development, validation, implementation, and oversees ongoing support to electronic case report form (eCRF) systems (e.g. InForm, etc.), external data acquisitions, reporting/business intelligence tools (e.g. J‐Review), and other programs (e.g. SQL,PL‐SQL, SAS, etc.). <br /> <br /> Supports development and implementation of departmental Standard Operating Procedures (SOPs) and work practices. <br /> <br /> The employee must conduct their work activities in compliance with all relevant laws, regulations, and <br /> regulatory guidelines as well as all Allergan policies and procedures. May be required to support inspection readiness activities, as well as participate in sponsor and site inspections. <br /> <br /> Key Duties/Responsibilities <br /> <br /> Responsible for the role which includes integration, aggregation and delivery of clinical study data. Work with external vendor on data acquisitions and peer review of deliverables and maintain technical interface with external data providers. <br /> <br /> May Support the role which includes implementation of data capture systems and methods, member of the CRF Review Team, providing ongoing support to data capture, and generation of reports for use in ongoing data review and reconciliation. Provides content expertise for programming <br /> activities from start‐up through statistical analysis stage of clinical studies to effectively manage data <br /> capture, review, and database lock activities. <br /> <br /> In addition, the incumbent is the key contact for Clinical Data Management, Research & Development <br /> Quality Information Technology (RDQIT), Statistical Sciences and Programming (SSP), Global Clinical Trial <br /> Management (GCTM), Global Site Management Operations (GSMO), Global Patient Safety & Epidemiology(GPSE), Clinical Development, and Non‐Translational Sciences (NTS). <br /> <br /> Responsible for the role which includes the implementation of quality, efficient, and consistent approaches to carrying out Clinical Programming tasks. Drives and contributes to continuous improvement. Delivering training to Clinical Programming and other functions/departments as necessary. Monitors compliance to controlled procedural documents (e.g. SOPs) and proactively addresses gaps in processes or understanding of processes by Clinical Programming staff. Supports Corrective and Preventative (CAPA) Action initiatives as needed. <br /> <br /> Minimum Requirements <br /> Bachelor’s Degree with demonstrated ability in Clinical Research, Computer Science, Project Management or related field. <br /> Strong knowledge of research and development, clinical trials execution, and understanding of regulatory requirements/guidelines (e.g. ICH, GCP, safety reporting). <br /> Strong knowledge and understanding of regulatory guidelines for the use of computerized systems in clinical trials. <br /> Strong knowledge of global standards related to clinical programming activities (data standards, database design, coding and coding dictionaries, etc.). <br /> Strong ability to work in a matrix environment and communicate effectively with different functional groups across the organization. <br /> Strong ability to foster open communication and practice active listening to encourage a collaborative team environment. <br /> Demonstrates a solution oriented approach to problem solving and a “can do” attitude. <br /> <br /> Note: While this job description is intended to be an accurate reflection of the job requirements, <br /> management reserves the right to modify, add or remove duties from a job and to assign other duties as necessary and at any time.</p> Eteam Madison NJ

Sr. Clinical Supplies

Expired Job