Current Open Positions
Clinical Supplies Manager
Leads the clinical supply chain logistics function within Clinical Operations. Serves as liaison between Clinical Operations, CMC and project managers to ensure appropriate supply of clinical trial material and sets lead time requirements to meet current and new clinical trial demands. Ensures that there is a standardized approach to clinical supplies logistics within the company and across studies.
- Responsible for the overall clinical supply chain – sourcing, forecasting, logistics, and import/export management
- Review clinical protocols and design appropriate supply chain strategy
- In collaboration with Clinical Operations, identify demand assumptions, enrollment rates, number of sites, and number of countries to understand CTM requirements
- In collaboration with data management, manage IRT/IXRS systems
- Identify, negotiate with, and manage CROs, depots and vendors that will package, label, and distribute CTM for worldwide clinical trials
- Monitor inventory levels and expiry dates of CTM at depots and clinical sites throughout the duration of clinical studies to proactively prevent downstream supply issues
- Author and maintain the Investigational Product Handling Manual/Pharmacy Manual to provide ongoing support to clinical trial site personnel.
- Support the procurement of raw materials
- Support the production schedule of drug substance/active pharmaceutical ingredients (API) and drug product
- Support the distribution of clinical supplies including both drug product and ancillary study supplies (e.g. lab kits from vendors to sites)
- Participate in strategic planning by providing logistics expertise to Sr. Team
- Develop metrics to analyze and monitor supply chain effectiveness
- Monitor storage and shipping conditions during transport, stock levels and backlogs
- Ensure best practices are introduced, developed and utilized
- Ensure outsourced resources, technology and procedures used by external partners or vendors align with resourcing and project management needs within clinical operations
- Contribute to yearly budget generation
- Write and review SOPs, where appropriate
- S. or Advanced Degree in a scientific or allied health field
- At least 5 years of work experience in the Biotech or Pharmaceutical Industry with at least 3 years direct experience in clinical supplies environment.
- Experience with IXRS systems, including direct knowledge of set-up and use of IXRS
- General understanding of GMP and GCP requirements for CTM
- Demonstrates ability to lead and develop staff within own team to ensure appropriate skills are developed and standardization is in place across function.
- Provides line management to junior staff while building capabilities of staff.
- Has proven ability to provide training and expertise cross-function.
- Has proven ability to create, implement and track using clinical logistics tools, techniques and standards cross-function.
- Comprehensive understanding of pharmaceutical regulatory requirements and impact on clinical supplies.
- Excellent verbal, written and presentation skills.
- Keeps up to date with industry practice and communicates key message back to Clinical Operations and other relevant groups as well as provides recommendations
- Demonstrate high level understanding of Clinical Supplies, Resource management, Budget Management and Risk Management.
- Strong attention to detail
- Ability to multi-task and manage complexity
- Comprehensive working knowledge of working with suite of Microsoft applications.
Clinical Trial Manager
Provides strategic and operational leadership of clinical research studies to ensure delivery on time, within budget, regulations/guidelines, and applicable SOPs. They are the primary operational contact for the study. Responsibilities may include operational direction of and oversight of the performance and quality of one or more Contract Research Organization (CRO) teams. They should have the ability to proactively identify and manage risk, have critical thinking skills for the problem solving and have the lateral and strategic thinking capacity to drive the study(ies) and understanding upstream, downstream and lateral implications of decisions that affect study outcomes and timelines.
ESSENTIAL DUTIES & RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO:
- Ensure clinical studies are conducted in compliance with FDA regulations, ICH guidelines, and company SOPs and policies.
- Manage sites and contract service providers (CSPs) for assigned studies.
- Manage study activities, including investigator recruitment and selection, study start-up, enrollment, data collection, drug projections, and reports
- CRO selection, development of RFPs, budget negotiations and management, and CRO management
- Manage CROs and other vendors, as applicable.
- Perform monitoring and co-monitoring visits, as necessary.
- Actively participate in technical and study design discussions and providing input to clinical trial outlines, protocols, and clinical study reports.
- Work with Medical Directors to resolve subject eligibility and protocol deviation issues.
- Participate in data review meetings.
- Manage and resolve study issues. Develop and manage study timelines in accordance with corporate, department and project goals. Identify barriers to enrollment, and develop and implement recruitment solutions.
- Perform additional tasks and duties as assigned.
- Minimum 5 years clinical study management experience including serving as study lead and global study experience
- Experience in oversight of CRO study execution preferred
- Clinical trial project management skills,
- Financial budgeting and forecasting skills,
- In depth knowledge of ICH/GCP, regulatory guidelines/directives, and drug development and clinical research processes,
- Disease / therapeutic knowledge preferred
The above description is intended to describe the general nature of the job and may include other duties as assumed or assigned; it is not intended to be all inclusive or limit the duties of the position.