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.
