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Grifols Shared Services North America, Inc Clinical Trial Material Project Manager in RTP, North Carolina

For more than 75 years, Grifols has worked to improve the health and well-being of people around the world. We are a global healthcare company that produces essential plasma-derived medicines for patients and provides hospitals and healthcare professionals with the tools, information and services they need to deliver expert medical care.

Summary:

This position is posted at two levels and will be filled at the level in which the chosen candidate processes the requirements for the role. The chosen candidate will manage the global clinical trial material supply for assigned Grifols-sponsored and Investigator-led clinical trials to ensure the right product is in the right place at the right time to meet clinical trial needs. Coordinates a multitude of clinical trial material tactical and project management activities throughout the clinical trial lifecycle including forecasting, vendor selection and project startup of new trials; study maintenance activities including packaging/labeling, distribution, and drug management and study wrap up activities including drug disposition and accountability.

Primary Responsibilities:

Maintains accountability for the short-term and long-range global clinical drug and placebo supply Sales and Operations Planning (S&OP) planning process, drug calculations for various protocol designs, and of inventory, expiration dates, and stability data for Grifols products.

Executes tactical tasks related to CTM study start up, including participating in the development of Request for Proposal Documents for CTM packaging/labeling/distribution and IVRS-IWRS vendors. Manages the development of country-specific label text approvals, translations, label design, and label proofs. Tracks packaging/labeling batch records for quality review. Develops Distribution Protocols with CTM packaging/labeling/distribution vendors. Develops IVR-IWR specifications. Develops CTM tracking systems for CTM release and shipments.

Procures ancillary supplies to meet clinical trial needs. Develops and reviews CTM training materials for investigator meeting presentations and pharmacy manuals. Initiates shipments to global depots and interfacing with CTM vendors on import requirements. Tracks CTM Release on a site level, and with Regulatory and QP release approvals, on a country level.

Manages and maintains appropriate levels of CTM supplies for assigned trials throughout lifecycle of trial per GCP/GMP including initiating and tracking CTM shipments, shipment receipts, depot inventories, site inventories, IVR-IWR functionality, lot numbers, expiry dates, packaging randomization codes, drug accountability, and other necessary documentation as defined on a per study basis. Monitors CTM shipping/distribution activities, identifying issues/variances, and recommending solutions. Monitors expiration dates and initiates action when expiration date updating is required. Maintains comprehensive CTM tracking systems by trial and provide updates to team members and management upon request. Functions as an unblinded contact for product technical complaints, temperature excursions, or other issues and works on resolution with minimal impact to study. Reviews CTM and IVR-IWR vendor invoices for accuracy and identifying any discrepancies. Performs study drug reconciliation activities. Maintains CTM files in the Trial Master File per GCP.

Attends clinical team meetings and reports key CTM items/issues to CTMM.

Participates in the authoring and/or reviewing of CTM processes/SOPs. Benchmarks activities against internal and external best practices. Tracks appropriate metrics and provide information to be used in periodic reports for the purpose of continuous improvement.

Additional Responsibilities:

Level 2: Manages CTM for studies with increased levels of complexity with minimal supervision. Interacts with other departments in start-up discussions. Provides input in the selection process and development of contracts/master service agreements. Participates in CTM vendor audits with QA. Assists with mentoring junior staff and is recognized as a subject matter expert on assigned studies. Designs appropriate distribution strategies for ancillary supplies, including labeling and import requirements by country. Assumes CTM budget responsibility for assigned trials. Participates in meetings with internal Grifols departments including Quality, Stability, Regulatory, and Bio Analytics. Level 3: Independently manages CTM for studies with advanced levels of complexity and is a recognized subject matter expert on assigned studies and a go-to person for general CTM questions. Reviews regulatory submissions for CTM documents for assigned trials. Assesses stability data requirements to suggest additional required studies and works with stability to design these studies. Ensures EU Qualified Person (QP) release requirements/ processes are in place. Reviews clinical protocols, IBs, and IND/IMPD/CTA regulatory submissions for CTM requirements. Assumes CTM larger budget responsibility for assigned trials. Alternates for CTMM participation on project team level meetings.

Requirements:

Level 2: Bachelor's degree, preferably in logistics, industrial engineering, pharmacy, business, or healthcare-related field. Requires 2 years of experience with global clinical supplies. Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a Bachelor’s degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate’s degree with 6 years of experience, or a Master’s degree with 2 years of experience.

Good knowledge of global clinical supplies including GMP clinical packaging, labeling/cold chain distribution practices, various type of clinical trial designs and their impact on the CTM and operations, and global CTM regulations. Good knowledge of the clinical trial material management through manual or electronic (IVR and/or IWR) processes. Good knowledge of the Clinical Development process including knowledge of ICH GCP, FDA GCP, and GMP guidelines. Good knowledge of continuous improvement methodologies preferred. Good knowledge of biologics preferred. Strong analytical, mathematical, problem-solving, and active learning skills. Strong organizational, process-orientation, and MS Excel skills. Strong communication and interpersonal skills. Ability to multitask in a demanding environment.

Level 3: Bachelor's degree, preferably in logistics, industrial engineering, pharmacy, business, or healthcare-related field. Requires 5 years of experience with global clinical supplies. Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a Bachelor’s degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate’s degree with 6 years of experience, or a Master’s degree with 2 years of experience.

Excellent knowledge of global clinical supplies including GMP clinical packaging, labeling/cold chain distribution practices, various type of clinical trial designs and their impact on the CTM and operations, and global CTM regulations. Good knowledge of the clinical trial material management through manual or electronic (IVR and/or IWR) processes. Excellent knowledge of the Clinical Development process including knowledge of ICH GCP, FDA GCP, and GMP guidelines. Excellent knowledge of continuous improvement methodologies preferred. Excellent knowledge of biologics preferred. Strong analytical, mathematical, problem-solving, and active learning skills. Strong organizational, process-orientation, and MS Excel skills. Strong communication and interpersonal skills. Ability to multitask in a demanding environment.

Attributes:

Work is performed in an office environment with exposure to electrical office equipment. Frequently sits for 6-8 hours per day. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Occasionally walks and stands. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 25lbs. Frequently drives to site locations with occasional travel within the United States. Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences. Interacts with others, relates sensitive information to diverse groups. Must work with diverse groups to obtain consensus on issues.

EEO Minorities/Females/Disability/Veterans

Location: [[mfield6]] : [[cust_building]]

Learn more about Grifols at http://www.grifols.com/es/web/international/home

Req ID: 79853

Type: Regular Full-Time

Job Category: Clinical Trials

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