Verified Job
Work from home
Project Manager - Clinical
Work from home
#50458
Remote / WFH
PCI Pharma Services
Job Description
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
We are PCI.
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
The primary responsibilities of this position are:
Accountable for overall project management for assigned projects/customers using appropriate project planning tools. Communicates milestones, critical path activities, and assigns internal and external responsibility to ensure the project achieves all deliverables for the customer requirements and agreed upon timelines.
Primary customer contact for clinical packaging activities and relationship management with the customer project teams for assigned projects/customers.
Creates and reviews project specific documentation including master batch records, finished product specifications, sample shipment request forms, printing and issuance form requests, bill of materials spreadsheets.
Ensures labels design and text is in accordance with the study set up. Monitors and updates scheduling liaison with production needs for project.
Coach, mentor, and train other new team members in an equivalent role and the Associate Project Managers / Coordinators
Assist in the development of detailed pack construction to ensure that the packaging is designed in a way that allows for efficient storage and distribution.
Responsible for leading Clinical Project Team and Technical Kick-Off Meetings for assigned projects and works closely with internal and external customers.
Provide support to business development for the estimation of new proposals and change orders as needed.
Assessment of clinical protocols, study specifications, contracts, and other documentation to ensure we mitigate risk and provide our clients with the best service and experience.
Provide the client with the highest level of professionalism, quality of work, communication/responsiveness, and status of deliverables.
Effectively facilitate a lesson learned with the client at the conclusion of every study to ensure we capture best practices, receive constructive feedback, and develop solutions and action plans to make the next project a bigger success.
Hard allocates lot specific bulk and materials to production labelling activities as needed.
Review and approve internal customer-based specifications for packaging components and processes.
Provide suggestions for packaging solutions in the areas of design and specification management.
In-depth understanding of clinical trials and supplies.
In liaison with the Distribution project team, ensure clinical supply is maintained.
Leads and creates minutes/agendas for customer calls for assigned projects.
Facilitates the billing of all activities involved labelling activities.
Supports project close out activities.
Coordinates Customer visits and facilitates activities as per customer needs.
Forecasting and managing the project budget.
Reviews Quotes to ensure scope is appropriate, initiates change orders where necessary and monitor project budget and scope creep.
Works closely with internal groups and vendors to ensure project milestones are achieved, including labelling and component design and delivery and on-time shipments of order requests.
Processes and records data in project specific metrics.
Maintains and updates project plans and timelines.
We are PCI.
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
The primary responsibilities of this position are:
Accountable for overall project management for assigned projects/customers using appropriate project planning tools. Communicates milestones, critical path activities, and assigns internal and external responsibility to ensure the project achieves all deliverables for the customer requirements and agreed upon timelines.
Primary customer contact for clinical packaging activities and relationship management with the customer project teams for assigned projects/customers.
Creates and reviews project specific documentation including master batch records, finished product specifications, sample shipment request forms, printing and issuance form requests, bill of materials spreadsheets.
Ensures labels design and text is in accordance with the study set up. Monitors and updates scheduling liaison with production needs for project.
Coach, mentor, and train other new team members in an equivalent role and the Associate Project Managers / Coordinators
Assist in the development of detailed pack construction to ensure that the packaging is designed in a way that allows for efficient storage and distribution.
Responsible for leading Clinical Project Team and Technical Kick-Off Meetings for assigned projects and works closely with internal and external customers.
Provide support to business development for the estimation of new proposals and change orders as needed.
Assessment of clinical protocols, study specifications, contracts, and other documentation to ensure we mitigate risk and provide our clients with the best service and experience.
Provide the client with the highest level of professionalism, quality of work, communication/responsiveness, and status of deliverables.
Effectively facilitate a lesson learned with the client at the conclusion of every study to ensure we capture best practices, receive constructive feedback, and develop solutions and action plans to make the next project a bigger success.
Hard allocates lot specific bulk and materials to production labelling activities as needed.
Review and approve internal customer-based specifications for packaging components and processes.
Provide suggestions for packaging solutions in the areas of design and specification management.
In-depth understanding of clinical trials and supplies.
In liaison with the Distribution project team, ensure clinical supply is maintained.
Leads and creates minutes/agendas for customer calls for assigned projects.
Facilitates the billing of all activities involved labelling activities.
Supports project close out activities.
Coordinates Customer visits and facilitates activities as per customer needs.
Forecasting and managing the project budget.
Reviews Quotes to ensure scope is appropriate, initiates change orders where necessary and monitor project budget and scope creep.
Works closely with internal groups and vendors to ensure project milestones are achieved, including labelling and component design and delivery and on-time shipments of order requests.
Processes and records data in project specific metrics.
Maintains and updates project plans and timelines.
