The Supply Chain Manager, Asia Pacific is a key member of Almac’s Asia Pacific operational team responsible for helping build Almac commercial and operational momentum in the Asia Pacific region and for advancing Almac’s reputation as a global leader in the provision of patient and trial supply management services. In this role, the Supply Chain Manager will support the expansion of the Almac Supply Chain Management Service offering in the APAC region.This position is offered on a fixed term (12 month) secondment and open to internal employees only (US & UK). Please see full job description below:
The principle function of the Project Services department is the day-to-day management of all Almac Clinical Services customers. The department coordinates all aspects of the delivery of a customer’s project as specified in the quotation. In order to achieve this, the department is divided into a customer support group and an operations support group. The operations support group is further divided into two key areas: production and distribution.
The Supply Chain Manager works within the customer support group and has overall responsibility for the successful setup and management of the clinical supply chain to ensure the correct drug is in the right place on time, for dispensing to patients enrolled in a clinical trial.
Responsibilities for any given Supply Chain Management (SCM) study will vary depending on scope of services contracted by the client. Depending on the support model, the Supply Chain Manager may assume overall responsibility for ensuring their customers projects are successfully delivered on time and to the agreed specifications. This is achieved by coordinating the tasks of the production and distribution groups, as well as the activities of other departments and divisions delivering aspects of the project. Job Specific Responsibilities include:
1. Support the expansion of the Supply Chain Management Service offering to the APAC region.
2. Train and develop staff to deliver supply chain management.
3. Review the protocol / synopsis and work with Business Development (BD), Operations, and the customer to determine the optimal kit design and packaging/ distribution strategy. The design should be appropriate for the clinical trial, based on considerations such as drug pooling, product characteristics, blinding requirements, dosing regime, visit schedule, availability and cost of bulk drug. Kit design should optimize the number of kits contained within distribution shipping units.
4. Work with BD and the customer to determine that the appropriate level of responsibility relevant to supply chain management is being transferred to Almac, and ensure this is included in the quotation and Technical Agreement.
5. Contribute to Project Management Documents (PMD) for all SCM studies.
6. Forecast the quantity of kits required throughout the clinical trial (or program) using Supplywise ™ ( Almac supply chain management forecasting tool) or other forecasting tools, based on considerations such as randomization scheme, numbers of patients / clinical sites / depots involved, shelf life of drug and projected / actual enrolment rates. Set up of the clinical forecast in a forecasting tool and ERP system where applicable.
7. Provide forecasting services as required for studies where Almac Clinical Technologies are contracted for this service but Almac Clinical Services are not providing packaging and labelling services.
8. Work with BD, Production and Project Services personnel to determine a manufacturing strategy for the trial including timing, quantities and lots to be used in production operations. Provide information to the Production project team to allow scheduling of production campaigns in line with patient requirements and drug / component availability. Communicate changes to manufacturing strategy as required during the course of the study.
9. Record all billable time spent in the Project Time Recording (PTR) System. Highlight to Business Development where project management hours is expected to exceed quoted amount.
10. Notify Business Development & Project Leader of any additional requests for SCM services by customers that have not been included in the quotation to enable Business Development to quote for the services. Identify opportunities for inclusion of additional value adding Almac services, discussing the most appropriate method to offer these to the customer with BD.
11. Attend internal and external kick off meetings. Disseminate all information from the customer accurately and promptly to all relevant internal/external stakeholders, ensuring any actions are understood and agreed with the project team as appropriate.
12. Work with Distribution and Depot Management to determine the most suitable distribution, returns and destruction strategy for the study, including selection of countries to be shipped directly from Almac and those countries requiring a depot or pass through, local, or regional hub, based on considerations such as availability of supplies, countries involved, randomization scheme, predicted / actual enrolment rates, drug product characteristics, consignment blinding and storage capacity at clinical sites / depots, shipping costs & import license requirements.
13. Participate in the distribution risk assessment providing information to the Distribution project team to allow distribution pathways, pack out plans, courier selection to be determined in line with the clinical study start date.
14. Ensure the optimal set up of the Interactive Response Technology (IRT) System in support of medication management. Activities include advising on site/depot IRT resupply parameters and inventory management algorithms. Ensure IRT set up is aligned with packaging, labeling and distribution strategies.
15. Ensure protocol set up and system design accounts for any specific project close out/drug reconciliation requirements.
16. Work with the Label Generation group on the design of the labels for the study, and if contracted, generate the Master English Label Text from a GMP compliance and patient perspective (not from a country regulatory perspective).
17. Prioritize, trouble-shoot and problem solve complex clinical supply issues.
18. Refresh forecast at agreed upon intervals throughout the study. Use appropriate tools to monitor the supply chain for the study throughout its life cycle proactively,
- Assessing actual trial activity, adjusting IRT medication management settings , packaging and distribution strategies as required to optimize the supply chain.
- Notifying the customer when additional drug product is required in sufficient time to meet production dates.
- Monitoring inventory at all depots and clinical sites throughout the course of the trial, to ensure there is drug available for dispensing to patients as and when required.
- Monitoring expiry dates of all input drug product, in support of long term planning, and work with the customer and IRT provider to agree a plan for expiry updating clinical supplies or replacing them when necessary.
- Use data analysis to identify and investigate trends in a protocol/program. Use the knowledge to enhance supply chain services by maximizing efficiencies and minimizing waste.
19. Approve documents on the customer's behalf, e.g. packaging documentation, Distribution documents, Quality documents, IRT documents, and temperature deviation reports.
20. Develop and maintain a close professional working relationship with other vendors e.g. IRT companies and Contract Research Organizations (CROs).
21. Where applicable support budget management processes by collating actual spend against predicted spend, and compare with total Purchase Order value. Proactively highlight to PL/BD where spend is expected to exceed quoted amount.
In support of a Combined Role:
- Assume the role of the Project Leader, where applicable to hold full responsibility for the timely delivery of projects through successful coordination of all tasks associated with packaging, labeling, distribution, supply chain management, set up and maintenance of WebEZ ™ studies.
In support of Integrated Services where Almac Clinical Technologies (CT) is providing IRT services, but the client has not contracted SCM services the Supply Chain Manager will not be client facing and will
- Act as a SCM subject matter expert for the completion of joint proposals, when requested. This may include providing an initial drug supply forecast during the proposal process and contributing to the preparation of participating in bid defense material.
- Work with the CT Project Manager to ensure optimal technology set up in support of medication management. Activities include: review of the IRT system specification and Drug Shipment Details (DSD), advising on site and depot trigger levels, ensure alignment with Clinical Services processes.
- Act as a subject matter expert for questions, urgent issues, and problem solving related to the study drug supply, IRT settings, and overall clinical supply chain. Directly assist project teams with complex supply chain issue resolution (such as drug shortages or re-labeling campaigns).
- Periodically monitor enrollment rates and inventory at all depots and clinical sites, and flag potential issues to the project team.
- Periodically monitor expiry dates of all finished goods, and flag potential issues to the project team. Consult with the CT Project Manager, and Project Leader to develop a plan for expiry updating clinical supplies or replacing them when necessary. The plan will be approved by the client.
- Participate in the Integrated Services project specific monthly review meetings and other internal project team meetings as needed.
- Develop and deliver training to staff on best practices, special topics, and related process changes.
- Provide input into requirements for service and tool enhancements associated with Integrated Services and play a role of business subject matter expert for these types of projects.
1. Attend meetings with BD and the customer to advise on blinding, packaging and distribution strategies.
2. Attend and present at bid defence meetings, investigator meetings and customer visits.
3. Attend regular update meetings with the customer during the course of the study (or program).
4. Participate in customer workshops and conferences, exhibiting subject matter expertise through presentations and general customer interaction.
5. Develop instructional materials to be used by the clinical sites.
6. Respond to customer complaints relating to supply chain management, according to defined Almac Clinical Services procedures and timelines, escalating within Almac when appropriate.
7. Contribute to Business Review Meetings (BRMs) as necessary to include finalisation of agendas, preparing relevant data and delivering presentations.
8. Receive and follow through on all customer queries, ensuring a response is supplied in a timely manner.
9. Ensure all customer contact, oral and written, is carried out with professionalism in order to develop and maintain good working relationships with each customers.
10. Communicate with all Clinical Trial stakeholders, as required.
Adhere to all Standard Operating Procedures (SOPs), Good Manufacturing Practice (GMP), and all aspects of GxP and associated legislation relevant to the packaging, labeling & distribution of clinical trials.
- Work to a high level of detail and accuracy on all documentation.
- Report any breaches in GMP compliance or any occurrences of substandard quality / poor customer service.
- Draft / update departmental SOPs, as required.
- Proactively identify opportunities to improve the quality of the services provided by Almac Clinical Services with regard to continuous improvement within the Project Services department.
- Support the department in the event of process changes.
- Work beyond standard days and hours when and where required.
- Provide regular updates to the Project Leader and Project Group Manager.
- Complete relevant departmental and customer Key Performance Indicators (KPIs) for specific projects.
- Fulfill any necessary administrative duties required to assist in the management of projects.
Travel as required to support/promote the SCM service.
The successful candidate will have a Bachelors degree (or equivalent), previous experience within a role involving Pharmaceutical Packaging and/or Distribution, Pharmaceutical Legislation, Supply Chain Management, IVRS/IWRS and proven Project Management experience.
Proven ability to build relationships with customers, partners and suppliers along with demonstrable knowledge of the clinical trial process and effective presentation and communication skills are all essential skills for this role.
Proficiency in the use of Microsoft Office packages (to include Word, Excel, Outlook and PowerPoint)
Effective communication skills (verbal, written, presentational and interpersonal) and proven customer focused approach
Proven ability to adopt a methodical approach, managing multiple tasks simultaneously whilst maintaining a high level of accuracy in all work carried out
Proven ability to identify and manage critical tasks and interdependencies
Ability to work effectively on own initiative and effectively contribute within a team environment
Effective negotiation and influencing skills
Effective problem solving and decision making ability
Proactive, decisive approach
Analytical, logical approach
Bachelor’s Degree (or equivalent) In a Life Science or Business Management related discipline
Level 2:1 or above; Postgraduate level (or equivalent) qualification
Proven experience within:
· Clinical supply chain management
· Clinical forecasting
· Clinical trial design
· Clinical trial packaging and/or distribution
· Business to Business Customer Service
· The use of MRP tools
Proven experience of integrating into, and/or leading, a multidisciplinary team
Proven experience in use of MS Excel (including pivot tables and macros)
Proven ability to compile logical, concise written instruction
Experience in Formal presenting
Prior to applying for this secondment opportunity please contact your line manager to ensure that you can be released from your current position for the duration of the secondment should your application prove successful. If authorisation is not obtained from your manager and you proceed with your application, you forfeit your right to return to your current post at the end of the secondment period.
An attractive remuneration package will reflect the importance of this role and will include the appropriate secondment related benefits for the length of the assignment in Singapore/Japan. Full relocation terms will be discussed at interview stage.
Apply online via the Altranet.
Sunday 27th April 2014 at 17:00 GMT