We, Lambda Therapeutic Research Limited are a leading global Clinical Research Organization (CRO) headquartered in Ahmedabad – India, with facilities and operations in Mumbai (India), Mehsana (India), Toronto (Canada), Warsaw (Poland), London (UK) and the USA with approximate 750 employees located in our facilities across the globe.
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Lambda offers full-spectrum clinical trial solutions empowered by more than 14 years of service to the biopharmaceutical and generic industry. At Lambda, our gamut of services under the clinical research domain is executed with comprehensive efforts, to deliver positive results. Led by a management team of highly qualified & experienced industry leaders, we apply innovative technologies, therapeutic expertise, and a commitment to quality in order to help clients develop products safely, effectively, and quickly.
Delivering the best is accomplished by hiring the best. Employees are the pillars that hold up every quality promise that we make. That’s why, we at Lambda are always looking for qualified and energetic individuals, with a desire for excellence, to join our team.
Position: General Manager – Clinical Trial Supply Management (CTSM)
Location: Ahmedabad, Gujarat
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.
- Manage clinical supply planning and forecasting for study protocols, with a focus on less complex study designs
- Serve as member of the clinical study team and/or clinical drug supply team, as assigned
- 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 the IVRS system
- Support financial planning for global clinical supplies, including budgeting, forecasting, and strategic planning activities for clinical trials and pharmaceutical development pipeline
- Manage drug supply delivery timelines with Clinical, packaging source area(s), and indirectly with GMP laboratories, QA and Regulatory Affairs, as required
- Prepare required 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
- Resolve issues involving the distribution of clinical supplies, including US & International shipments, temperature excursions, etc.
- Manage clinical supply complaints received from investigative sites and/or subsidiaries, address supply replacement requests.
- Monitor expiry dating for clinical study supplies.
- 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 the comparator, other NIMP and/or ancillary supplies
- Manage clinical supply planning and forecasting for study protocols with more complex study design
- Participate in the 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 a 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
- Demonstrates knowledge of global clinical trials and the drug development process.
- Experience in vendor oversight and managing external partnerships and relations.
- Understands comprehensive global pharmaceutical regulatory requirements (e.g. cGMP, GDP, and GCP).
- Experience in deviation investigation and CAPA implementation.
- Strong analytical, problem solving, and communication skills.
- Strong collaboration and excellent team skills to be successful in cross-functional and multi-cultural teams.
Experience: 15-18 Years
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