RFD_Clinical Assoc Proj Mgr

PCI Pharma Services•Rockford, IL

5d•$56,720 - $63,810•Onsite

About The Position

Supports assigned clinical customer projects to ensure that project goals and objectives are accomplished within the prescribed time frame, budget, and in accordance with customer expectations and pharmaceutical regulatory requirements. Manages and plays an integral part in strategic customer relationships and individual project success to provide PCI a competitive advantage in long-term customer management. Diligently manages significant matters pertaining to assigned projects to “Provide the industry’s leading customer experience” supporting PCI Clinical Service’s long term growth and success.

Requirements

Associate's Degree in a related field and/or 1-3 years related experience and/or training.
Basic Mathematical Skills
Intermediate Computer Skills: Ability to perform more complex computer tasks and has knowledge of various computer programs.
Minimum Professional Proficiency: Ability to speak in a way that allows one to participate effectively in various conversations.
Ability to read various types of standard items addressed to general readers.
Intermediate Reasoning: Ability to apply common sense understanding to carry out instructions that may be furnished in written, oral, or diagram form.
Ability to deal with problems that involve several concrete variables in standardized situations.

Nice To Haves

Ability to work independently and/or as part of a team.
Ability to display excellent time management skills.
Ability to display a willingness to make decisions.
Ability to adapt to changing work environments.

Responsibilities

Responsible for completing critical tasks required for clinical production while ensuring accuracy and completion on-time.
Creates project specific documentation including packaging specification, variable data form, label request forms, sample shipment request forms, monthly finished goods inventories, logistic management document, returns accountability worksheet, monthly distribution billing spreadsheets, etc.
Routes documentation for internal and external approval.
Answers questions from stakeholders and makes corrections if needed.
Uses critical thinking skills, logic and ingenuity to resolve issues and unique challenges while remaining within cGMP guidelines and PCI work practices and guidelines.
Provides continuous support to Project Manager and stays up to date on basic status of client projects owned by the team.
Responsible for managing internal receipt and release of material.
May include working with warehouse, procurement, labeling, client, quality and lab to ensure all materials are available when needed as well as resolution of Non-Conforming Material Reports.
Submits production schedule requests to meet needs for project.
Monitors schedule, identifies and participates in resolving conflicts or delays.
Participates in customer calls (weekly and ad hoc). Leads these calls in absence of Project Manager.
Creates and publishes client-facing agendas and minutes for weekly customer teleconference calls.
Ensures Shipment Requests are shipped on time and works urgently with client, Orders Team, and warehouse to resolve any issues that may arrive to eliminate patient impact.
Responsible for tasks related to project set-up, pre-production tasks related to work orders, S&D Billing, printing of inventoried documents, etc.
Works with customers to resolve discrepancies on end of study returns.
Creates accurate Inventory Disposition Report upon client request and obtains approval for destruction of material.
Assists in hosting customer visits at PCI.
Training and on-boarding of new employees, as requested.
Knowledge of and adherence to all PCI, cGMP and cGCP policies, procedures, rules and regulations as applicable.
This position may require overtime and/or weekend work.
Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules.
Attendance to work is an essential function of this position.
Performs job duties as assigned by manager/supervisor.