Trial Supplies Manager from Innova Solutions

Innova Solutions is immediately hiring a Trial Supplies Manager

Job Title: Trial Supplies Manager
Position type: Full-time Contract
Duration: 06 Months
Location: Remote, USA
Pay range: $74 -$ 78 Per Hour

As a Trial Supplies Manager, you will:

This position is responsible for the supply planning and inventory management of clinical supplies required to support global clinical research and development studies during phases 1-4.
The individual must partner closely with clinical, regulatory, quality and production associates to ensure timely delivery of supplies to study participants.

• Collaborating with internal and external Customers and Service Providers, including but not limited to Clinical Research and Development, Global Study Management and Monitoring (GSMM), Project Management, Affiliates, Medical Affairs (MA), Regulatory, CMC, QA, Packaging Vendors, CRO's, IRT Organizations, and Global Clinical Supply Chain Functional Operations to ensure all needs are met.
• Working with teams for optimal use of the investigational material supply chain to achieve study and corporate goals.
• Identifying and supporting strategies for continuous improvement and departmental and/or inter-departmental projects.
• Co-creating clinical and development timelines and directly responsible for communicating timelines and investigational product strategies to Study Teams as well as cross-functional teams.
• Proactively defining, planning, and communicating clinical supply strategy in support of global clinical studies, as well as monitoring and reacting to unforeseen clinical demand changes.
• Developing supply forecasts through evaluation of the clinical development plan and protocol analysis.
• Reviewing and providing input for draft medical protocols to develop packaging and labelling configurations and create packaging specifications in collaboration with Clinical Operations partners.
• Collaborating with Global Clinical Supply Chain functions and external Vendors on the package design and label development for investigational products to meet all protocol and regulatory requirements.
• Monitoring long-term inventory and allocation strategies considering drug recertification, country specific regulatory requirements, international drug shipment and overall demand.
• Performing analytical assessments of drug utilization as it pertains to current forecasts versus inventories and creating product orders as needed.
• Working with third party vendors to ensure the timely, efficient, high-quality, cost-effective execution of all outsourced clinical supply activities.
• Ensuring releasable supplies for all assigned compounds and Protocols considering country Regulatory and QP Release documentation and requirements.
• Initiating, reviewing and approving IRT specifications. Participating in user acceptance testing.
• Developing investigational product distribution strategies maintaining distribution and supply strategy at depot and site level according to study (and IRT) requirements.
• Actively participating in Trial Supplies Management Functional team, Study Team, Country Medical Affairs Affiliate & CSC Matrix Team Meetings providing all relevant data and documentation prior to each meeting, highlighting any risks and mitigation required.
• Actively supports the CSC Budget Process.
• Acting as the main Clinical Supplies contact person for the assigned Compound and associated studies, lead communications regarding global supply strategy with Study Team or Country Affiliate Medical Affairs team as appropriate.
• Proactively identifying strategic and operational issues and develop proposals outlining solutions.
• Managing conflicts / issues with internal and external partners and customers.
• Demonstrating strong knowledge when presenting clinical supply processes at cross-functional meetings and actively participates.
• Ability to coach new Trial Supply Managers on individual tasks.
• Participating in training efforts for external functions on clinical supply processes to facilitate improved cross-functional relationships.
• Speaking at Investigator Meetings as required.
• Traveling as required (10%).
• Writing of / input to departmental SOPs.
• Performs other tasks as assigned.
  
  Required:
• Moderate / Strong knowledge of the global drug development process and global regulatory requirements.
• Proficient and strong analytical skills.
• Strong communication and negotiation skills.
• Proficient and strong Project management skills.
• Strong knowledge of Forecasting and Planning and proficient knowledge of related areas, i.e. Manufacturing, Packaging & Labelling, IRT, Logistics, Quality, Stability, etc.
• Proficient knowledge of import / export requirements.
• Proficient/Strong knowledge of IRT and CTMS systems.
• Proficient / Strong knowledge of industry technology.
• Applies and drives Forecasting and Planning activity as it relates to protocol.
• Ability to build/drive internal team consensus.
• Translates broad strategies into specific objectives and action plans.
• Conflict resolution (manages disagreements).
• Negotiation (Manages Execution, Results Driven, Analysis of Issues, Effective Speaking, Builds Relationships).
  
  Must Haves:
• Phase 1 to 4 clinical trial experience
• Managing end to end supply chain
  
  Other Qualifications:
• Bachelor's degree required.
• 2 years of relevant work experience required, preferably in a pharmaceutical environment.
• As a key partner to many functions within the clinical supply chain and the broader research and development business this opportunity provides access to a wealth of learning and development possibilities within the pharmaceutical business.
  
  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!
  Sara Almas
  Team Recruitment
  
  
  PAY RANGE AND BENEFITS:
  Pay range: $74 -$ 78 Per Hour
  
  *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 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.

American Cybersystems, Inc is acting as an Employment Business in relation to this vacancy.