Senior Manager, Clinical Trial Materials

This is a fully remote position, open to applicants in Netherlands.

📋 Description

• Analyze and interpret a clinical protocol or study overview.

• Provide feedback during the development phase of the clinical protocol.

• Calculate the total demand and translate it into a demand forecast.

• Collaborate with Project Managers to establish clinical supply timelines, gather study overviews and drug requirements, and initiate procurement processes.

• Regularly review and update inventories, including all supply-related information such as lot numbers, current status, kit genealogy, and expiration date extensions.

• Monitor expired materials and place orders for retrieval or disposal.

• Demonstrate proficiency with current inventory and tracking systems by learning their functionalities, updates, and maintenance.

• Suggest and implement enhancements to ensure efficient clinical supply operations.

• Investigate and resolve issues related to inventory, shipments, and returns.

• Oversee the complete CTM lifecycle, ensuring that all clinical trials have a timely and uninterrupted supply of CTM.

• Coordinate CTM activities with Clinical Supply Packagers and Distributors, Technical Services, Clinical R&D teams, Project Teams, IT/IS, Data Management, CROs, and other departments as required.

• Develop and maintain CTM documentation to support company policies, procedures, and all regulatory guidelines.

• Collaborate with Clinical, Regulatory, and Quality teams in preparing label text, obtaining translations, and approving label proofs.

• Prepare and review relevant contracts, project statements, change orders, packaging requests, and batch records for accuracy and completeness.

• Reconcile and approve invoices.

• Generate reports to ensure the accuracy and completeness of clinical supplies information. Maintain departmental reports and files, and update SOPs and other projects as assigned.

⛳️ Requirements

• Bachelor's degree (BS) in Health Science is preferred (Master's degree is a plus). Equivalent combinations of relevant education and applicable job experience will be considered, with a minimum of 4-6 years of experience in pharmaceutical development focused on clinical trial materials.

• The candidate should be well-informed about GXPs (GMP, GCP, and GDP) as well as other regulatory requirements related to investigational products.

• Demonstrated project management capabilities.

• Ability to manage multiple projects simultaneously.

• Solid understanding of GMP working environments and regulatory guidance and regulations (e.g., ICH, 21 CFR Part 11).

• Familiarity with IRT system setup and user testing.

• Strong negotiation skills with both customers and suppliers.

• Hands-on training and experience in clinical trial methodologies and Good Clinical Practice.

• Excellent organizational and documentation skills.

• Proven ability to self-direct and resolve issues with vendors, CRO staff, and internal teams.

• Exceptional written and verbal communication skills.

• Capable of effectively conveying detailed information to all levels within and outside the organization.

• Ability to foster a cooperative team environment.

• Competent in objectively assessing situations and making recommendations for changes based on overall project demands.

🏝️ Benefits

• Competitive base salary, bonuses, new hire, and ongoing equity packages.

• Medical, dental, and vision insurance coverage.

• Employer-paid life, disability, business travel, and EAP coverage.

• 401(k) plan with a fully vested company match of 1:1 up to 5%.

• Employee Stock Purchase Plan with a 2-year purchase price lock-in.

• 15+ vacation days.

• 13-15 paid holidays, including office closure from December 24th to January 1st.

• 10 days of paid sick leave.

• Paid parental leave benefit.

• Tuition assistance program.