Career Category

Project Management

Job Description

Leadership

• Provide oversight, management, and mentorship to Associate roles
• Engage and delegate appropriately
• Ensure transparency through excellent communication
• Generate and maintain process playbooks
• Facilitate training of new staff
• Ensure timely completion of all assigned training

Program & Study Planning

• Host and manage meetings both internally and with external suppliers to minimize risk and optimize delivery of results.
• Plan and forecast study budgets; own early planning in Planisware.
• Obtain Life of Study budget approvals through study leads.
• Proactively manage budgets, purchase orders, and change orders.
• Liaise with study team members and other relevant cross‑functional stakeholders to ensure adherence to quality and timeline deliverables.
• Review draft protocols for accuracy and update budget requirements and study timelines as needed

CRO & Vendor Management

• Serve as point of contact between external suppliers and internal stakeholders
• Assist in supplier evaluation, onboarding, and monitoring
• Assign staff and studies to activities and ensure awareness of all stages of method transfer, study support, and reporting
• Execute CRO study contracts using specifications provided or reviewed by study team members.
• Ensure timely completion of training assigned to CROs/External Workers
• Manage analytical method support documentation including dosing documents, reagent qualifications, reagent expiry extensions, and reports
• Manage CRO deliverables, timelines, invoices, and contract budgets.
• Coordinate transfer of documents, data, and materials to/from CROs.
• Ensure documents are stored in compliant locations (eg rIM, TMF)
• Collaborate with CROs to generate analytical plans.
• Ensure CRO flags reagent expiration risks and maintain accurate reagent tracking.
• Monitor reagent inventory, expiration dates, and ensure timely replenishment.

Material & Sample Management

• Oversee material procurement, shipping, and logistics coordination.
• Coordinate transfers of critical reagents, including to secondary CROs when needed.
• Request BA Lab Ops support for vial labeling as needed.
• Communicate shipment details to CROs.
• Execute sample disposition strategy.

Cross‑Functional Communication & Alignment

• Manage and lead recurring cross-functional meetings
• Provide critical updates to stakeholders and ensure alignment on major discussions.
• Inform BA of upcoming requirements (new indications, BE studies, geographies, co‑med considerations).
• Update CST on timeline changes and bring in BAPS/SMPA when needed.
• Notify BAPS and SMPA of significant report issues and escalate delays or quality concerns.
• Contribute to study plan development and maintenance of external collaboration sites.

Protocol, Timeline & Issue Management

• Review study protocols and amendments for collection timepoints and testing strategy.
• Populate study timeline trackers and maintain issue trackers.
• Coordinate with Associates for RIM requests and facilitate document review cycles.
• Request reviews from stakeholders and coordinate scientific reviews as needed.
• Archive final study documents and provide study index and correspondence in RIM.

Reporting & Documentation

• Provide final reports to medical writers, RS, CI‑PTR, and CPMS.
• Communicate any supplier issues and support remediation efforts.

.