Summary:

Under the direction of the General Manager, Supply Chain, the Clinical Operations Team Leader leads and manages the daily depot operations including staff and operational daily scheduling for the Pharmaceutical team. Clinical Operations Team Leader also handles complex problem resolution ensuring the quality and integrity of all processes related to stored material: reception, storage, shipment, return and/or destruction, according to Standard Operating Procedures or any other required standard.

 

This position is categorized as compliance critical and, as such, requires and is assigned specific responsibility for ensuring continual and proper compliance with all division, corporate and regulatory requirements.

Responsibilities:

• Fulfills job responsibilities as a Technical Representative of the Clinical Trials Supply Chain Service in its country, according to legal requirements. Maintain and assure compliance with current International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, Good Practice, Federal Drug Agency, Good Clinical Practices, International organization for Standardization guidelines or any other as required in the position training program

• Monitors the overall performance of staff members to ensure compliance with guidelines above

• Maintains established procedures concerning quality assurance, security of controlled substances and record keeping

• Ensures regulatory compliance standards are adhered to, and that regulatory information is transferred appropriately to local staff and the corporate compliance team

• Manages the restrictions (scope, cost, time, human resources, etc.) to guarantee the depot complies with the expected performance indicators

• Be aware of the metrics related to depot operations and assure the business continuity taking part in the planning process and business development activities

• Identifies and escalates to the General Manager Supply Chain and Human Resources any possible issue related to the depot staff that may impact the operational performance and/or working environment, such as change in local regulation, union representations, etc

• Actively works on World Courier Guidelines review and update

• Leads department meetings and in-service training for staff

• Train team members on the process as an Subject Matter Expert and develop training plan for each team member to ensure compliance and competency

• Assures that all Customers’ concerns are duly assessed and follows-up the implementation of any preventive/corrective action. Responds to customer inquiries, requests, and issues when situations demand escalation to a higher level of authority

• Assists the Quality Assurance team in the internal audits performed by World Courier Quality Assurance Department providing all the requested information during the process and assuring the completion of all action plans

• With the assistance of Quality Assurance Specialist, attends Customer`s audits at the Depot

• Collaborates with internal departments to make reports in a timely manner

• Scheduling of depot rosters / shifts

• Responsible for planning and tracking daily orders and depot activities

• Required to be available on call 24/7 to provide telephone assistance in case of an emergency or urgent request as well as in person attendance for emergency response in case of any concern occurring at the facility in relation to temperature control of the product

• Participate in reviewing and authoring global and local Standard Operating Procedures, Work Instruction’s and Tracking Reference Number documents

• Work in all temperature controlled environments including but not limited to

• +15 to +25°C

• +2 to +8°C

• -20 to -30°C

• Physically perform packing process of inbound, outbound and returned shipments using Cencora World Courier packaging products where required.

• Participate in occasional scheduled weekend tasks for stock control, balance sheet and cold chamber cleaning processes.

• Lead continuous Improvement initiatives to ensure processes are streamlined.

• Fully trained in the Clinical Enterprise Resource Planning

• Verifies and signs operation jobs

• Have deep knowledge of all the protocols stored at World Courier Depot to provide instructions to all the Depot Staff.

• Willingness to be trained how to use Export Waiver Process equipment and/or Forklift

• Required to be available on call 24/7 to provide telephone assistance in case of an emergency or urgent request.

• Perform any other duties the employee has been trained for as assigned

Internal Communication and Information Sharing

• Keep Internal Stakeholders informed of the progress of their order and shipment

• Collaborate with Internal Stakeholders to find appropriate resolutions to Clinical and Commercial matters to ensure ongoing client satisfaction

• Liaise with the Transport Customer Service team in relation to World Courier transport bookings and ensure correct processes are followed

• Provide information to all World Courier Australia business units to ensure work output is coordinated in an effective manner.

• Contribute to team and organisational wide discussions by sharing ideas, experiences and recommendations around improving the effectiveness and efficiency of the business.

Teamwork and Collaboration

• Effectively collaborate with all Internal Stakeholders to ensure the function is operating effectively and efficiently, while maintaining a harmonious team environment

Policy and procedure

• Comply with standard operating procedures and policies to ensure that the function is demonstrating consistent practices nationally and is in line with strategic objectives

• Ensure World Courier Australia compliance with all government legislative and other requirements such as Australia Customs Service, Civil Aviation Safety Authority, Australian Quarantine and Inspection Service, International Air Transport Association, International Organization for Standardization

• Ensure full compliance with international local regulations such as World Courier Australia Registered Air Cargo Security Program (Registered Air Cargo Security Program) Australian Customs International Air Transport Association regulations

• Ensure full compliance with World Courier Australia quality management systems (Good Practice)

 Workplace Health and Safety

• Actively promote a culture that values a safe and healthy workplace

• Take reasonable care of, and cooperate with actions taken to protect;

  • The health and safety of both themselves and others

  • Report all accidents, incidents and hazards to their supervisor as soon as is practicable

• Ensure compliance with relevant Occupational Health & Safety legislation and that any issues are identified and actioned in line World Courier Australia policy

Reports Directly To:

General Manager, Supply Chain

.

Experience:

• Normally requires two (2) to four (4) years directly related and progressively responsible experience, including at least one (1) year in a management role and preferably in the Clinical Trial business

• Preferable for candidate to have some work experience in warehousing

• Minimum Year 12 VCE or equivalent

Education:

• Preferable to have a broad training in fields such as business administration, accountancy, sales, marketing, computer sciences or similar vocations

Minimum Skills, Knowledge and Ability Requirements:

• Full command of English: written and oral skills

• Position will require being able to lift loads up to 20kg independently using safe lifting methods described in manual handling training

• Ability to work quickly and accurately under time and volume constraints as well as under pressure

• Strong decision-making skills

• Strong interpersonal skills

• Strong leadership skills

• Good analytical skills

• Ability to resolve customer issues quickly and creatively to improve customer satisfaction

• Strong organizational skills; attention to detail

• Be able to take initiatives and responsibilities

• Sound Computer skills. Knowledge of Microsoft Word, Excel, PowerPoint, and Outlook

• Growth mindset demonstrated by willingness to participate in projects outside standard scope, being open to feedback, a willingness to ask for help, and support of employee growth and development

• Demonstrate flexibility, creativity, and problem-solving skills to adjust team strategies and processes as required, as well as resolve Client issues

• Ability to arrange data in an understandable manner and present the information to others

What Cencora offers

​Benefit offerings outside the US may vary by country and will be aligned to local market practice. The eligibility and effective date may differ for some benefits and for team members covered under collective bargaining agreements.

Full time

Affiliated Companies

Affiliated Companies: World Courier (Aust) Pty. Ltd

Equal Employment Opportunity

Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law.

The company’s continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory.

Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call 888.692.2272 or email [email protected]. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned