Responsibilities * 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).