Advanced Clinical is a global clinical development organization that provides CRO, FSP, Quality & Validation, and Strategic Resourcing services for biopharmaceutical and medical device organizations. Our mission is to deliver a better clinical experience for our clients. With global experience in over 50 countries, we are committed to improving all lives touched by clinical research. We understand the complex nature of the clinical research industry and approach each opportunity with compassion. Together, we answer the hopes of patients and healthcare professionals with industry-leading services in global life-sciences. As part of the Advanced Group family of companies, Advanced Clinical employees provide the support, structure, and professional background and experience for better clinical trials and research. They are the foundation of our energetic and collaborative environment, where constant learning and service to others take top priority. We seek dynamic, hard-working team members who are inspired to work amongst diverse backgrounds and perspectives. From our altruistic mission to outstanding career development opportunities, there's no better place to grow your career than Advanced Clinical.
Provides leadership of the Clinical Trial Supplies Management (CTSM) team to ensure appropriate inventory levels and logistics management of clinical trial supplies, including (but not limited to) investigational product and ancillary clinical supplies. Ensures successful operational and financial delivery of services rendered for clinical trials.
- Support of P&L management for CTSM services
- Oversee a team of Clinical Trial Supplies Associates and Clinical Trial Supplies Managers to manage logistics of clinical trial supplies
- Oversight of the delivery services for CTSM, ultimately ensuring customer satisfaction.
- Identify and manage preferred vendors and depots to manufacture, package, warehouse, distribute, and destroy clinical trial supplies
- Oversee Clinical Trial Supplies team activities and resourcing capacity to deliver work in alignment with the project budget and goals
- Collaborate with the head of the department (or delegate) and Finance to create departmental budget
- Provide updates and reports to senior leadership on Clinical Trial Supplies team activities as required
- Develops strong relationships with current and prospective clients to generate new and/or add-on business for the future
- Implement technology solutions to create efficiencies and enhance the service offering for CTSM.
- Maximize productivity to meet/exceed AC budget goals.
- Development of new processes and identification of improvements to current processes, and initiate a plan to improve or develop said processes.
- Develop and establish training programs for CTSM resources that abide by defined processes
- Responsible for recruitment, hiring, onboarding, training, management and firing of CTSM personnel
- Train, mentor, monitor, and supervise CTSM personnel and other appropriate personnel as necessary.
- Coordinate assignments across programs to ensure all targets and deadlines are met
- Direct the process and requirements for CTSM candidate recruitment and hiring
- Conduct evaluations for direct reports according to company policy and procedures.
Standard Operating Procedures (SOPs)
- Be familiar with and follow department SOPs.
- Ensure staff is adequately trained on and following SOPs.
- Create and review SOPs to recognize and prevent potential regulatory issues.
- Assist with RFP/RFI completion
- Provide strategy and pricing approval for proposals
- Supports the Business Development Department by providing information on Company's capabilities, patient populations, etc. and attends and presents Company capabilities as well as project management specific responsibilities at Customer proposal defense meetings
- Works with Business Development and the Proposal/Contracts groups to develop proposals for Customer requested opportunities; works with this team to develop budgets and scope of work for the final contract.
- Participate in governance board meetings with clients as appropriate
- As needed to support the team, participate in or take responsibility for CTSM: updating, compiling, and reporting various clinical tracking information; managing clinical studies; and any other tasks within the scope of CTSM.
- Participate in clinical training programs and developmental programs in the field of clinical research, as needed.
- May participate in quality or process initiatives.
- Participate with Marketing toward corporate objectives
- Provide GMP Quality consultation for in-house clinical projects or stand-alone regulatory projects regarding clinical trials supply management
- May function as a Clinical Trial Supplies Manager for strategic customers and/or high complexity trials
- Perform other duties as requested by management
Pharmacy or Bachelor's degree in a health-care or scientific discipline with 10 years of pharmaceutical and/or device industry experience working on clinical trials and 5 years of experience in a team leadership capacity plus Prior experience in a contract research organization (CRO), pharmaceutical, or biotechnology company in Clinical Trial Supply Management; or equivalent combination of education, training and experience. FSP Experience a plus. Certification:
None required, PM Certification or Healthcare licensures or certifications preferred. Training:
GCP (including 21 CFR 11 and E6R2), HIPAA - Privacy Rule and Protected Health Information , GDPR Experience:
The ideal candidate should have:
What's in it for you?
- Strong knowledge of Good Clinical Practice/ICH guidelines/Good Manufacturing Practices and other applicable regulatory requirements
- Experience utilizing IVRS (Interactive Voice Response Systems)
- Excellent organizational skills and problem solving skills
- Exceptional team leadership skills and proven industry vision
- Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince and persuade
- Flexibility and ability to handle multiple tasks to meet deadlines while delivering high quality work in a dynamic environment
- High level of competency in English language
- Proficiency with MS Office Applications
- Ability to travel as necessary (up to 20%)
- Efficient and effective time management skills with ability to successfully manage competing priorities.
- The ability to establish and maintain effective working relationships with executive management, coworkers, managers and clients.
Advanced Group offers competitive compensation, comprehensive benefits packages, and a flexible work environment designed to help our team members and their families stay healthy, meet their financial goals, and generally thrive in and beyond work. Visit the links below to discover all that Advanced Group has to offer: Our Culture:
https://careers.advancedgroup.com/embrace-our-culture Career Development Opportunities:
https://careers.advancedgroup.com/realize-your-potential Community Programs:
For a complete list of all of our job openings, please visit Advanced Group's career site here .
It is Advanced Group's practice not to discriminate against any employee or applicant because of sex, race, color, age, national origin, religion, gender identity or expression, sexual orientation or sexual preference, pregnancy or maternity, genetic information, marital status, disability, veteran status, or any other basis protected by applicable federal, state or local law.
This practice applies to all terms and conditions of employment including, but not limited to, hiring, training, compensation, benefits, promotions, transfers, layoff, Company-sponsored education, social and recreational programs, and treatment on the job. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter so that we can discuss the appropriate alternatives available.