Innova Solutions is immediately hiring for an Clinical Supply Chain Manager
Position type: Full-time; Contract
Duration: 06+ Months
Location: 100% Remote
Pay range: $70 - $80/hr on W2
As a Clinical Supply Chain Manager Professional you will:
Job Description:
Manager, Supply Chain, is an enthusiastic team player who will provide expertise in a fast-paced pharmaceutical clinical supplies environment for Client`s global clinical trials.
The Manager works collaboratively with other members of GCSC, PDM and DevOps staff to meet project deliverables, solve business problems and create competitive advantage.
This role has great exposure to all elements of the clinical supply chain from the protocol design through manufacturing to the ultimate distribution and inventory management of clinical supplies at the clinical sites worldwide.
Specific Job Requirements:
Responsible for managing supplies for dynamic clinical studies associated with multiple clinical development programs across the lifecycle of the programs (Phase 1, 2, 3, Managed Access).
Leads end -to-end clinical supply responsibilities including but not limited to protocol interpretation, demand planning, supply planning, distribution, inventory management, label generation and planning and execution of labeling operations at partner contract manufacturing organizations (CMOs).
Works collaboratively with Clinical Operations, Formulation Process Development, Device Development and Clinical Package Engineering, Quality Assurance, Regulatory, Outsourced Manufacturing and Project Management partners to develop optimal supply strategies and ensure on time delivery of clinical supplies to initiate and resupply studies with investigational medicinal product (IMP).
Partners with Quality Assurance to resolve quality-related issues with labels/labeling/distribution vendors in a timely manner and develops holistic corrective actions to prevent recurrence.
Partner with Regulatory to ensure labels meet global regulatory requirements and filings accurately reflect the global supply chains.
Oversees labeling/distribution contractor activities and relationships and participates in vendor selection, onboarding, management, issue resolution and continuous improvement.
Actively participates in and supports continuous improvements programs, processes and systems.
Stays current with industry trends and best practices with respect to clinical supply management as well as changes in the regulatory landscape that would impact clinical supply chain.
Authors and reviews SOPs and labeling batch records required for distribution and clinical labeling activities to ensure GMP compliance.
Prepares and/or approves purchase orders and supports the budgeting process.
Examines functional issues from a broader organization perspective and supports day to day operation activities as needed.
Knowledge:
Excellent verbal, written, and interpersonal communication skills.
Strong computer and organizational skills. Project management experience.
Able to anticipate client obstacles and difficulties and act upon this to meet goals.
Ability to write clear, concise, and error-free documents.
Ability to exercise judgment within defined procedures and policies to determine and take appropriate action.
Possess a strong knowledge of the FDA, cGMP, and GCPstandards as well as regulatory guidance documents such as Annex 13.
Possess clinical supplies experience/knowledge in forecasting, demand / supply planning, IRT systems, inventory management, clinical labeling and distribution including cold chain, import/export, and reverse logistics.
Possess strong collaboration, influencing and negotiation skills to work effectively with internal cross-functional groups and external suppliers to meet the aggressive clinical study timeline and patient needs.
Works well with ambiguity, can assess options quickly and efficiently and implement best option in alignment with Client`s culture and expectations for clinical timelines.
Education and Experience:
Requires a bachelor's degree preferably in a science-related field
8+ years of relevant industry experience (preferably in end-to-end clinical supply management including clinical labeling)
Required Years of Experience:
5-8 years progressive experience in Supply Chain within the biotech, pharmaceutical, industry
Required Degree or Certification:
Bachelor's or master's degree in business administration, Operations Management, or similar education required.
Top 3 Required Skill Sets:
Demonstrates knowledge of global clinical trials and the drug development process.
Knowledge of IRT system setup and functionality and proficiency with Excel modeling.
Strong collaboration and excellent team skills to be successful in cross-functional and multi-cultural teams
Top 3 Nice to Have Skill Sets:
Experience in deviation investigation and CAPA implementation.
Experience in vendor oversight and managing external partnerships and relations.
Strong analytical, problem solving, and communication skills.
The ideal candidate will have : 5-8 years progressive experience in Supply Chain within the biotech, pharmaceutical, industry
Qualified candidates should APPLY NOW for immediate consideration! Please hit APPLY to provide the required information, and we will be back in touch as soon as possible.
We are currently interviewing to fill this and other similar positions. If this role is not a fit for you, we do offer a referral bonus program for referrals that we successfully place with our clients, subject to program guidelines. ASK ME HOW.
Thank you!
PATHAN? SAMIULLAHKHAN
Lead - Recruitment
(+1) 971-925-2783
pathan.samiullahkhan@innovasolutions.com
PAY RANGE AND BENEFITS:
Pay range: $70 - $80/hr
*Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc.
Benefits: Innova Solutions offers benefits( based on eligibility) that include the following: Medical & pharmacy coverage, Dental/vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP).
ABOUT INNOVA SOLUTIONS: Founded in 1998 and headquartered in Atlanta, Georgia, Innova Solutions employs approximately 50,000 professionals worldwide and reports an annual revenue approaching $3 Billion. Through our global delivery centers across North America, Asia, and Europe, we deliver strategic technology and business transformation solutions to our clients, enabling them to operate as leaders within their fields.
Recent Recognitions:
One of Largest IT Consulting Staffing firms in the USA - Recognized as #4 by Staffing Industry Analysts (SIA 2022)
ClearlyRated® Client Diamond Award Winner (2020)
One of the Largest Certified MBE Companies in the NMSDC Network (2022)
Advanced Tier Services partner with AWS and Gold with MS
Website: https://www.innovasolutions.com/
Innova Solutions is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. Innova Solutions is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, sex, age, physical or mental disability, veteran status, marital status, domestic partner status, sexual orientation, or any other status protected by the statutes, rules, and regulations in the locations where it operates. If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact us at hr@innovasolutions.com or (770) 493-5588. Please indicate the specifics of the assistance needed. Innova Solutions encourages all interested and qualified candidates to apply for employment opportunities. Innova Solutions (HireGenics/Volt) does not discriminate against applicants based on citizenship status, immigration status, or national origin, in accordance with 8 U.S.C. § 1324b.
The company will consider for employment qualified applicants with arrest and conviction records in a manner that complies with the San Francisco Fair Chance Ordinance, the Los Angeles Fair Chance Initiative for Hiring Ordinance, and other applicable laws.
