Assist with preparation, tracking, and distribution of project documentation such as meeting agendas and minutes.
Ensure compliance with internal SOPs and timelines to ensure timely study start-up and initiation of client projects.
Monitor and collaborate with staff to ensure timely delivery of final project documents to clients.
Collaborate with technical staff and/or supervisor to identify scope changes and submit SOW revisions to proposal manager staff.
Assist with maintenance of various information systems related to project and customer data such as project trackers and timelines in PM software.
Collaborate with laboratory and finance departments to ensure accurate and timely client invoicing; support verification of project completion and pricing in PM software.
Field, and appropriately escalate, customer requests, inquiries, and complaints and collaborate with project managers, sales, and operations colleagues on solutions.
Ensure adherence to pertinent regulatory requirements and to departmental policies, GMP practices, and procedures [SOPs, safety procedures and biosafety protocols].
Learn and become familiar with regulatory requirements; GLP, GCP, OECD, 21CFR Part 11.
Perform all other related duties as assigned.
Skills, Education & Qualifications
Education: Bachelor's degree (B.A./B.S.) or equivalent in project management, business, biological sciences, or related discipline.
Experience: minimum 0-2 years related experience in project management in a regulated laboratory or research environment. Experience in a CRO preferred.
An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
Other: Excellent written and verbal communication skills, ability to multi-task, excellent organizational skills, and attention to detail. Must possess analytical thinking and problem-solving skills. Ability to prioritize and re-evaluate priorities as situations change. Working knowledge of computer software (MS Office, MS Teams, Excel, and database experience preferred).
Project Planner to work with the Project Management team and clients.
Numbers & Facts
Location
Malvern, PA
Skills
Analysis Skillsunmatched
Billingunmatched
Biologyunmatched
Code of Federal Regulationsunmatched
Communication Skillsunmatched
Computer Softwareunmatched
Contract Research Organization (CRO)unmatched
Customer Escalationsunmatched
Customer/Client Researchunmatched
Database Technologyunmatched
Detail Orientedunmatched
Documentationunmatched
Establish Prioritiesunmatched
Financeunmatched
GCP (Good Clinical Practices)unmatched
GLP (Good Laboratory Practices)unmatched
GMP (Good Manufacturing Practices)unmatched
Information Technology & Information Systemsunmatched
Maintain Complianceunmatched
Meeting Minutesunmatched
Microsoft Excelunmatched
Microsoft Officeunmatched
Multitaskingunmatched
Organizational Skillsunmatched
People Managementunmatched
Presentation/Verbal Skillsunmatched
Pricingunmatched
Problem Solving Skillsunmatched
Project Management Softwareunmatched
Project Planningunmatched
Project/Program Managementunmatched
Regulatory Complianceunmatched
Regulatory Requirementsunmatched
Research Laboratoryunmatched
Safety Processunmatched
Sales Operationsunmatched
Standard Operating Procedures (SOP)unmatched
Startupunmatched
Statement of Work (SOW)unmatched
Systems Maintenanceunmatched
Technical Leadershipunmatched
Time Managementunmatched
Writing Skillsunmatched
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