JOB DESCRIPTION - Almac



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|JOB DESCRIPTION |

|DATE: |November 2018 |

|POSITION: |Project Manager |

|BUSINESS UNIT: |Almac Clinical Services |

|LOCATION: |Craigavon |

|REPORTING TO: |Project Group Manager |

|RESPONSIBLE FOR (PEOPLE): |NA |

OVERALL ROLE OBJECTIVE:

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 the 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 Project Manager working in Production is responsible for ensuring the completion of all tasks associated with the successful management of the manufacture and packaging of clinical trial supplies at any Almac Clinical Services (ACS) site. The Project Manager working in Distribution is responsible for ensuring the completion of all tasks associated with the successful management of the distribution and return of clinical trial supplies at any Almac Clinical Services (ACS) site.

JOB SPECIFIC RESPONSIBILITIES:

The post holder will:

Production

1. Hold full responsibility for the management of projects involving production activities only when no Project Leader is assigned. Serve as the primary point of contact for the customer. Including the generation of PMD / TA where required.

2. For projects involving more than one Almac facility serve as the point of contact for the Global Project Leader. Responsible for driving the completion of all production tasks at the home facility.

3. Direct the activities of Production Project Coordinators as required.

4. Approve documentation to support drug product and component receipt for production activities, to include generation of POs and resolution of RIs for all receipts.

5. Review and where applicable approve written instructions for the manufacture/packaging of each batch of material, ensuring full compliance with current Good Manufacturing Practice.

6. Coordinate the translation, design, proofing and generation of labels for production activities and liaise with Label Generation as necessary.

7. Generate Medication Number List Import Forms, if applicable.

8. Calculate quantities of drug product and input components needed per production campaign.

9. Oversee the allocation of drug product and components to production campaigns

10. Provide regular updates to the PL on the project plan; track the progress of the production operations against the project plan and advise the Project Leader, when applicable, of any issues arising throughout the course of the project. Escalating project-specific production issues to the Project Team or Project Group Manager as appropriate.

11. Be fully responsible for project plan when no Project Leader is assigned.

12. Perform all duties of a Project Coordinator as required.

13. Coordinate rework of returned material per customer request.

14. Monitor inventory levels and expiry dates of components to ensure adequate levels of inventory are available for future production campaigns. Initiate the order for ancillary supplies and components for production campaigns as needed. Ensure appropriate approvals are obtained.

15. Approve change requests for material receipt and production related documentation.

16. Generate quality incident reports and technical queries relating to project specific production issues.

17. Develop in conjunction with the Operational Departments batch document templates for new production processes.

18. Ensure accurate and complete set up of all production related activities in COSMOS.

Distribution

1. Hold full responsibility for the management of projects involving distribution only activities only when no Project Leader is assigned. Serve as the primary point of contact for the customer, including the generation of PMD / TA where required.

2. For projects involving more than one Almac facility serve as the point of contact for the Global Project Leader. Responsible for driving the completion of all distribution tasks at the home facility.

3. Provide regular updates to the PL on the project plan; track the progress of the distribution activities against the project plan and advise the Project Leader, when applicable, of any issues arising throughout the course of the project. Escalating project-specific distribution issues to the Project Team or Project Group Manager as appropriate.

4. Direct the activities of Distribution Project Coordinators as required.

5. Coordinate the design, proofing and generation of labels for distribution and liaise with Label Generation as necessary.

6. Work with the customer and Depot Management to determine the role of each depot (pass through, pick and pack, etc.)

7. Set up distribution protocols in COSMOS to enable a timely and accurate drug delivery process.

8. Generate distribution instructions, depot project instructions, and drug return instructions.

9. Generate Medication Number List Import Form for Distribution - only studies.

10. Work with ALMAC Clinical Technologies and other IRT providers to establish drug shipment details, FTP, and inventory release functionality.

11. Review and approve order requests generated by sites prior to processing, where applicable.

12. Set trigger levels, monitor inventory levels and expiry dates of shipping components (e.g. shippers, temp tales), ancillary supplies (e.g. syringes, dosing instructions/leaflets, alcohol swabs) and ancillary drug supplies (e.g. rescue medications) to ensure adequate levels of inventory are available for subsequent shipments from Almac warehouses and depots. Initiate orders for additional supplies as needed.

13. Monitor expiry dates of finished goods and notify the Project Leader and/or customers as needed.

14. Coordinate the assembly and distribution of materials for relabeling to sites, depots and clinical monitors.

15. Attend customer meetings to provide training to sites and/or clinical monitors on the distribution aspects of the project.

16. Perform all duties of a Project Coordinator as required.

17. Approve change requests for finished goods receipt and distribution related documentation.

18. Generate quality incident reports, and technical queries relating to project specific distribution issues.

19. Identify, analyze, and solve distribution related issues, ensuring high customer service levels. Take ownership and exhibit professionalism, poise and urgency in issue resolution.

20. Foster synergy with Distribution and Logistics operational groups to create alignment and collaboration in the execution of Distribution tasks.

Customer Service (Production and Distribution)

1. Ensure all customer contact is carried out in a high level of professionalism in order to develop and maintain good working relationships with each customer.

2. Notify Business Development of any additional requests for services by their customers that have not been included in the quotation, to enable Business Development to quote for the services.

3. Receive and follow through on all customer queries ensuring a response is supplied in a timely manner.

4. Coordinate and attend customer meetings, which may require attendance at off-site meetings.

5. Take minutes and generate agendas and action items for customer meetings and teleconferences.

6. Generate routine customer specific reports.

7. Deal with customer complaints according to defined procedures and escalate to the Project Leader as appropriate.

8. Maintain a professional approach at all times while representing Almac.

Other (Production and Distribution)

1. Work overtime when and where required.

2. Provide support and act as the back-up to the Project Leader when applicable and as deemed necessary by the Project Group Manager.

3. Perform all routine project maintenance and initiate close out activities; ensuring critical tasks are completed in a timely manner.

4. Provide regular updates to the Project Leader for global projects.

5. Ensure project related documentation is stored in LiveLink in the appropriate project folder.

6. Complete departmental Key Performance Indicators (KPIs) for specific projects as required.

7. Fulfil any necessary administration duties required to assist in the management of projects.

8. Log all billable time in the Timesheet system. When there is no Project Leader assigned, monitor actual hours logged against the estimate in the quotation and inform BD as actual hours logged approaches the estimate (i.e. at 50%, 75%, etc.).

This role requires occasional travel and coverage beyond normal working hours on a regular basis. It is a condition of your employment that you are able to fulfil this requirement of the role.

GENERAL ROLE RESPONSIBILITIES:

|Quality |Ensure GMP is adhered to in all areas of work. |

|Health & Safety |Understand Company’s Health & Safety Policy and follow all company |

| |HSE procedures. Report all accidents or any unsafe conditions in |

| |the work place. |

|Training and Development |Ensure training has been received before undertaking specific duties|

| |and that all training is recorded in training records. |

|Human Resource Management |Adhere to all HR policies and procedures, to include all absence |

| |policies and procedures. |

|Communication |Communicate within your own department to ensure that all relevant |

| |information is forwarded to the appropriate personnel on a regular |

| |and timely basis. Provide regular updates to your line manager |

| |regarding progress on required duties and the status of any |

| |projects. |

|Equal Opportunities |Observe and adhere to the company's Equal Opportunities and Dignity |

| |at Work policies ensuring that a neutral and harmonious work |

| |environment is maintained in which bullying and/or harassment does |

| |not occur. |

|Core Competency Framework |Ensure that all job specific responsibilities relating to the |

| |overall role objective are carried out in accordance with the |

| |requirements outlined within the Almac core competency framework. |

|By signing this Job Description I accept that I have received and read the Job Description and have accepted the responsibilities |

|identified therein. |

|EMPLOYEE’S SIGNATURE: | |

|PRINT NAME: | |

|DATE: | |

|This job description should not be regarded as conclusive or definitive. It is a guideline within which the individual jobholder works.|

|It is not intended to be rigid or inflexible and may alter as the Company’s strategic direction changes. |

|PERSON SPECIFICATION |

|DATE: |November 2018 |

|POSITION: |Project Manager |

|BUSINESS UNIT: |Almac Clinical Services |

|LOCATION: |Craigavon |

|REPORTING TO: |Project Group Manager |

|RESPONSIBLE FOR (PEOPLE): |NA |

| | | | |

| |ESSENTIAL |DESIRABLE |ASSESSMENT METHOD |

| |REQUIREMENT |REQUIREMENT | |

| | | | |

|QUALIFICATIONS |Bachelor’s Degree (or equivalent) |In a Life Science, Engineering or Business Management |Application Form |

| |qualification |related discipline level 2:2 or above | |

| | | |Documentary Evidence |

| | | | |

|EXPERIENCE |Proven experience of working on own |Proven experience within the pharmaceutical or clinical |Application Form |

| |initiative and as part of a |supplies industry | |

| |multidisciplinary team with a successful | |Interview |

| |outcome |Previous experience within a business to business | |

| | |customer service role | |

| |Proven experience of generating | | |

| |instructional documentation with a high |Previous experience within a Production / Manufacturing | |

| |attention to detail |/ Laboratory / Quality Control / Quality Assurance / | |

| | |Project Management environment | |

| | | | |

| | |Previous experience working with an ERP system | |

| | | | |

|KEY SKILLS |Proven project management skills – ability |Proficiency in the use of Microsoft Project |Psychometric testing/ |

| |to plan, prioritise and manage multiple | |Interview |

| |tasks simultaneously, adopting a methodical|Working knowledge of the drug development process and | |

| |approach whilst maintaining a high level of|clinical trials legislation | |

| |accuracy in all work carried out | | |

| | | | |

| |Ability to process high volume of technical| | |

| |information | | |

| | | | |

| |Demonstrate effective communication skills,| | |

| |both written and verbal | | |

| | | | |

| |Effective problem solving and decision | |Psychometric Testing |

| |making ability | | |

| | | | |

| |Analytical, logical approach | | |

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|ALMAC CORE COMPETENCIES |

| | | |

|COMPETENCY |BEHAVIOUR |ASSESSMENT METHOD |

| | | |

|RESULTS DELIVERY |Delivers results on time, within constraints and in line with company |Interview |

| |policy and procedure and organisational strategy. Demonstrates a | |

| |continuous drive for quality and a commitment to excellence. | |

| | | |

|PROACTIVE SOLUTIONS |Analyses and uses experience and logical methods to make sound decisions|Interview |

| |which solve difficult problems. Seeks practical/workable and innovative | |

| |methods to deliver solutions. | |

| | | |

|LEADS BY EXAMPLE |Promotes a clear vision and mission. Acts as a positive role model for |Interview |

| |the organisation, fostering a climate of teamwork and development. | |

| | | |

|COMMUNICATION |Communicates clearly and effectively. Promotes the exchange of ideas and|Interview |

| |information across the organisation. Fosters dialogue to ensure everyone| |

| |understands what is going on. | |

| | | |

|CUSTOMER FOCUS |Strives to exceed the expectations and requirements of internal and |Interview |

| |external customer; acts with customers in mind and values the importance| |

| |of providing high-quality customer service. | |

| | | |

|JOB SPECIFIC KNOWLEDGE |Demonstrates required job knowledge and understanding to successfully |Interview |

| |and competently fulfill or exceed the requirements of their post. | |

| |Follows correct procedures and guidelines (SOPs). | |

| |Proactively demonstrates a desire to enhance and develop their job | |

| |knowledge. | |

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