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Global Clinical Trials Supply Chain Manager
2 months ago
We are seeking a highly skilled and experienced Clinical Supply Chain Manager to join our team at Cpl Life Sciences. As a key member of our Global Clinical Supply Chain organization, you will play a critical role in ensuring the timely and efficient delivery of clinical supplies to support our clients' global portfolio of clinical studies.
Key Responsibilities- Develop and maintain supply strategies for investigational products, ensuring compliance with scientific and regulatory requirements.
- Collaborate with internal teams and external partners to ensure seamless supply chain operations.
- Proactively define and communicate clinical supply chain strategies to promote optimal use and alignment with study and corporate goals.
- Identify and support strategies for continuous improvement, both departmental and inter-departmental.
- Develop supply forecasts for studies through evaluation of the clinical development plan and protocol analysis.
- Monitor inventory and analyze drug utilization versus forecast, taking into account country requirements and logistical timelines.
- Issue manufacturing and packaging/labelling requests to Clinical Supply Operations in alignment with RDSC Master Planning timelines.
- Monitor use date of investigational drug product for assigned protocols and support use date extension activities.
- Ensure timely delivery of quality clinical supplies for all assigned compounds and protocols.
- Participate in development, review, and approval of Interactive Response Technology (IRT) specifications.
- Develop investigational product distribution strategies and maintain distribution and supply strategies at depot and site level.
- Actively participate in internal Trial Supply Management and Clinical Supply Chain meetings, Study Team meetings, and Clinical Supply Matrix Team meetings.
- Collaborate with Clinical Supply Strategic Sourcing team to procure commercial drug in alignment with country and clinical study requirements.
- Act as the main Clinical Supplies contact person for the assigned compound and associated studies.
- Support associated actions stemming from change controls.
- Prepare eTMF, CSR appendices, and batch listings to support inspection readiness activities.
- Enter product complaints and deviations in appropriate systems and work with PDQ for investigation and resolution.
- Manage conflicts/issues with internal and external partners and customers.
- Minimum 2 years of experience in the Pharma industry, with a minimum of 1 year in Clinical Supplies/Development with global experience.
- Strong knowledge of the global drug development process and global regulatory requirements.
- Proficient analytical skills, with strong communication and negotiation skills.
- Proficient project management skills, with strong knowledge of forecasting and planning.
- Proficient knowledge of import/export requirements, IVRS, and CTMS systems.
- Ability to build/drive internal team consensus and translate broad strategies into specific objectives and action plans.
- Team and individual leadership skills, with the ability to foster open communication and manage disagreements.
