Project Manager, GMP/GDP

Company overview

Marken, UPS Healthcare Precision Logistics (formerly Marken, MNX & Polar Speed), the clinical and advanced therapy subsidiary of UPS Healthcare, unites expertise across healthcare and complex secure logistics to drive the success of our clients through innovation.

Job Purpose:

The main purpose of the Project Manager’s role is the overall responsibility for successful set-up, implementation, maintenance and close out of all assigned projects and serve as the client main point of contact.

Main Duties and Responsibilities:

Reporting to the CTD Project Management Team Lead, this person will be responsible for successfully leading the set up and implementation of distribution projects. This will include capturing client requirements during study start up and coordinating with the various Marken internal teams to ensure all requirements are met.

They will manage projects including the following service scope:

• Receipt, storage, distribution and return of investigational and commercialised products. Active Pharmaceutical Ingredients (API). Named Patient, Expanded Access Programs. Packaging and labelling. Depot-to-Patient Services. Import/Export requirements for international shipments. Depot to site logistics. Procurement of products or ancillaries from approved vendors.
• Take project ownership at handover from the commercial team. Review of project scope per the budget.
• Assess and raise project risks and implement mitigation strategies where applicable.
• Build and maintain relationships with clients, establish communication plans. Develop appropriate critical path schedules ensuring consensus of milestone dates consistent with business and client expectations.
• Work with Trade Compliance, Branch Operations and Marken LSP’s to ensure all project logistics requirements and process’ are understood and implemented.
• Draft project related documents for operational departments (Depot, Customer Service & Logistics) to ensure adequate handling of patient shipments and adherence to project specific requirements (product and temperature conditions).
• Ensure all required set-up activities are in place and train all internal operations teams prior to Go-Live.
• Create billing trackers, handover and train the billing team within required period. Proactively resolve client invoice queries. Support the billing team where required to ensure on time execution of client and third-party depot invoices.
• Lead regular client calls. Prepare agenda and circulation minutes promptly.
• Maintain project oversight when the study is in maintenance phase. Update documents and systems as required.
• Be the single point of contact for the client and internal teams for assigned projects. Escalate to CTD Team Lead any issues that have or may occur
• Manage the project budget to ensure all out of scope work is identified, agreed with the client and a Change Order executed.
• Raise Deviations in Marken QMS and ensure on-time delivery to client. Support or lead investigation as required.
• Other responsibilities include dealing with project enquiries, preparation and maintenance of study reports and KPIs, initiating change orders where required. Assisting in client audits, SOPs review and input.
• Ensure compliance with national and international standards and legislation.
• Travel as reasonably requested by the Line Manager for the performance of duties.
• Undertake any other reasonable duties at the request of the Line Manager.
• Adhere to all company SOP & Policies at all times.

Requirements:

• Sound knowledge of local and Clinical Trial Regulations • Good Manufacturing Practice (GMP)
• Good Distribution Practice (GDP)
• Strong project management and organizational skills.
• Proven self-management skills and ability to efficiently prioritize tasks, proactive working style. Ability to work on multiple projects at one time.
• Excellent interpersonal, verbal and written communication skills.
• Team-oriented way of working
• Proficiency in Microsoft Office (Word, Excel, PowerPoint, Project) •
• Minimum of 2 years project management experience, ideally in a clinical trials environment
• Bachelor’s Degree in a related field of study preferred but not essential