Senior Manager - Production Clinical Supplies

Role & responsibilities

General Description:

- The In-charge of Lambda Clinical Services Limited manages clinical trial supply activities related to planning, label development, label & pack, and distribution for one or more clinical programs.

- Actively develops and oversees supply plans to ensure accurate and continuous supply to patients while reducing risk and minimizing waste.

- Represents Clinical Supply Chain to internal stakeholders and manages relationships with external supply partners. Works with management to develop and implement process improvements to build the organization for the future.

Essential Functions:

- Manage clinical supply planning and forecasting for study protocols, with focus on less complex study designs.

- Interpret relevant protocol information to develop packaging/labeling design and/or global distribution strategy.

- Coordinate the origination, proofing, and translation of clinical study labels, as required.

- Support design and set-up of IVRS system.

- Support financial planning for global clinical supplies, including budgeting, forecasting, and strategic planning activities for clinical trials and pharmaceutical development pipeline.

- Assist for documentation and assist internal and external stakeholders to facilitate activities for the import and export of clinical supplies, as required.

- Maintain close communications with all internal-chain groups to ensure the adequate supply of clinical supplies throughout the duration of a clinical trial.

- Monitor global clinical supply inventory for both IVRS and traditional studies via tracking of specific milestone dates and adjusting drug distribution plan accordingly.

- Monitor expiry dating for clinical study supplies.

- Resolve issues involving distribution of clinical supplies, including US & International shipments, temperature excursions, etc.

- Manage clinical supply complaints received from investigational sites and/or subsidiaries, address supply replacement requests.

- Interact with other departments, as needed, to resolve any issues involving clinical supply inventory and distribution.

- Ensure that all tasks meet Sponsor and Lambda expectations, and are delivered in accordance with the contract, trial protocol, ICH/GCP and applicable SOPs.

- Coordinate procurement activities for comparator, other NIMP and/or ancillary supplies.

- Manage clinical supply planning and forecasting for study protocols with more complex study design.

- Participate in implementation of improvement initiative(s).

- May serve as a resource for and interact with other functional areas to resolve site issues and facilitate trial timelines.

- May mentor junior level Clinical Supply Managers and serve as a resource for new employees.

- Manage clinical supply planning and forecasting for study protocols with focus on the most complex study design.

- Serve as a resource for and interact with other functional areas to resolve site issues and facilitate trial timelines.

- Serve as SME for managers throughout the organization on issues related to clinical supplies and project management.

- Lead improvement initiative(s) and implementation.

- Develop supply strategies to maximize supply efficiency, minimize waste while identifying risk and develop risk mitigation plans.

- Assist in the creation of Standard Operating Procedures.

- Additional responsibilities as required.