RFD_Clinical Assoc Proj Mgr

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.

Summary of Objective:

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. Manage and play 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.

Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.

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.

Route documentation for internal and external approval.

Answer questions from stakeholders and make corrections if needed.

Use critical thinking skills, logic and ingenuity to resolve issues and unique challenges while remaining within cGMP guidelines and PCI work practices and guidelines.

Provide continuous support to Project Manager and stay 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.

Submit production schedule requests to meet needs for project.

Monitor schedule, identify and participate in resolving conflicts or delays.

Participate in customer calls (weekly and ad hoc).

Leads these calls in absence of Project Manager.

Create and publish client-facing agendas and minutes for weekly customer teleconference calls.

Ensure Shipment Requests are shipped on time and work 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.

Work with customers to resolve discrepancies on end of study returns.

Create accurate Inventory Disposition Report upon client request and obtain approval for destruction of material.

Assist 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.

Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Required:

• 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.

Preferred:

• 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.

The hiring rate for this position is $56,720-63.810, plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors, including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), a flexible spending account, and a 401(k) plan.

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Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future

Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

At PCI, Equity and Inclusion are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.