Program Manager I – Biopharmaceutical

Jobtailor; Northern (KY); On-site; USD 70,000 - 95,000; Full time

Job summary

Jobtailor in United States (Kentucky region) is seeking a Project Coordinator to liaise with PPD departments, coordinate study setup, and serve as local study coverage for global trials.

You will manage study activities, document communications, support supply orders, schedule meetings, and assist PMs on budget and protocol changes, with adherence to GMP and confidentiality; travel may be required.

Qualifications

• Bachelor’s degree or equivalent and relevant formal academic qualification.
• 0–2 years of experience or equivalent education, training and experience.
• Strong organizational and multi-tasking abilities.
• Good written and verbal communication skills.
• Knowledge of clinical trial processes and programs.

Responsibilities

• Liaise with PPD operational departments, affiliates, and sponsors
• Coordinate study setup, maintenance, and closure activities for protocols and study programs
• Serve as local study coverage for global studies and contact for Clinical teams
• Ensure timely completion of study activities and deliverables
• Document communications and actions with sponsors or investigator sites
• Manage existing Batch, Supply Only, and In Conduct studies
• Develop new study setups with the Tech Ops group
• Provide backup coverage for centralized Project Management staff and PMs
• Advise PMs on procedural and budgetary items, study modifications, and amendments
• Monitor monthly Budget-to-Burn reviews and contract modifications
• Support initial study supply orders, supply templates, and shipment requests
• Monitor completion of shipment requests
• Schedule internal and external meetings and teleconferences
• Prepare and distribute agendas and meeting minutes
• Monitor assignments and adjust priorities to meet deadlines
• Complete additional tasks supporting project, client, and departmental objectives

Skills

Project Management

Clinical Trial Processes

Organizational Skills

Attention to Detail

Effective Communication

Education

Bachelor's degree or equivalent

Tools

Supply Chain Management

Project Management Software

Meeting Scheduling Tools

Job description

• Liaise with PPD operational departments, affiliates, and sponsors


• Coordinate study setup, maintenance, and closure activities for identified protocols and study programs


• Serve as local study coverage for global studies and point of contact for Clinical teams


• Ensure timely completion of study activities and deliverables


• Document communications and actions with sponsors or investigator sites


• Manage existing Batch, Supply Only, and "In Conduct" studies


• Develop new study setups in collaboration with the Tech Ops group


• Provide backup coverage for centralized Project Management staff and Project Managers


• Advise Project Managers on procedural and budgetary items, study modifications, and protocol amendments


• Monitor monthly Budget-to-Burn reviews and contract modifications


• Support initial study supply orders, supply templates, and shipment requests with Supply Chain Management


• Monitor completion of shipment requests


• Schedule internal and external meetings and teleconferences


• Prepare and distribute agendas and meeting minutes


• Monitor assignments and adjust priorities and work schedules to meet deadlines and deliver high-quality deliverables


• Complete additional tasks supporting project, client, and departmental objectives

Requirements

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification


• Previous experience comparable to 0 to 2 years, or equivalent combination of education, training, and experience


• Good organizational skills and ability to manage multiple assignments with changing priorities and challenging/conflicting deadlines


• Effective project management and organizational skills


• Good computer skills


• General knowledge of clinical trial processes and programs


• Strong attention to detail and problem-solving skills


• Good written and verbal communication skills


• Ability to effectively conduct oral presentations


• Demonstrated experience identifying and resolving technical problems in a professional environment


• Ability to maintain confidentiality with clinical teams


• Ability to attain, maintain, and apply working knowledge of applicable procedural documents


• Must be legally authorized to work in the United States without sponsorship


• Must be able to pass a comprehensive background check, including drug screening


• Ability to work in environments involving GMP safety standards, biological fluids, infectious organisms, hazardous materials, and required personal protective equipment


• Ability to make occasional drives to site locations and occasional domestic travel

Core Competencies

Demonstrates strong project management capabilities, effective communication skills, and a solid understanding of clinical trial processes. Ability to manage multiple assignments while ensuring compliance with GMP safety standards and maintaining confidentiality.

Highest-signal resume keywords

• Project Management


• Clinical Trial Processes


• Organizational Skills


• Attention to Detail


• Effective Communication

ATS Optimization Keywords

Hard Skills

• Study Setup Coordination


• Budget Monitoring


• Document Management


• Problem-Solving


• Technical Problem Identification

Soft Skills

• Good Organizational Skills


• Ability to Manage Multiple Assignments


• Strong Attention to Detail


• Effective Oral Presentation Skills


• Ability to Maintain Confidentiality

Industry Keywords

• GMP Safety Standards


• Clinical Trials


• Biological Fluids


• Infectious Organisms


• Hazardous Materials

Tools & Technologies

• Supply Chain Management


• Project Management Software


• Meeting Scheduling Tools