Project Manager

• Serve as the project manager for new business opportunities, including RFPs, RFIs, proposals, bids, and partnership discussions.
• Develop and manage detailed project plans, timelines, deliverables, and responsibilities for each new business opportunity.
• Coordinate cross-functional contributors to ensure timely and high-quality proposal development.
• Track progress, risks, dependencies, and deadlines; proactively address issues to keep proposals on schedule.
• Present CPC capabilities to potential partners & funders.
• Partner interactions will span the full project life cycle including relationship initiation, proposal preparation and presentation, transition from proposal to contracting, project kickoff and transition to internal teams, project status updates to the partner and change management, and project closure.
• Develop and maintain positive business relationships with current and new customers; establish regular communication with current clients to provide ongoing updates on project spend, anticipated changes, etc.
• Act as the primary coordinator between business development, operations, finance, legal, and subject matter experts during the pre-award phase.
• Facilitate internal meetings related to new business pursuits, including planning sessions, reviews, and bid defenses.
• Ensure alignment on scope, assumptions, resourcing, and pricing throughout the proposal lifecycle.
• Support development and refinement of project budgets, schedules, and scope of work in collaboration with finance and operational leads.
• Track changes to scope or assumptions and ensure updates are communicated and documented appropriately.
• Assist with preparation of supporting documentation for pricing, contracts, and approvals.
• Lead or support the transition of awarded projects from new business into execution, ensuring a smooth handoff to delivery teams.
• Compile and organize project documentation needed for operational kickoff and onboarding.
• Ensure commitments made during proposal development are clearly communicated to execution teams.
• Work with the Contracts team on contract negotiations (including change orders and amendments), as necessary; ensure the scopes of work accurately align with the approved budgets.
• Maintain proposal trackers, dashboards, and status reports for leadership visibility.
• Identify opportunities to improve new business project management processes, tools, and templates.
• Support standardization of proposal management best practices.
• Perform other duties as deemed necessary.

Project Manager, Business Development

Clinical Operations

• Oversee clinical operations management activities
• Define and monitor project scope, timelines and deliverables from project initiation to close-out
• Identify project-specific training for team members and notify appropriate designee to ensure completion and filing of training documentation
• Oversee trial-related activities
• Track and approve vendor payments
• Provide expert advice in the design, writing and/or review of all project-related essential documents including protocols, project management plans, case report forms, statistical analysis plans, project management plans, ICF templates, study procedure manuals, source documents, site newsletters, study reports, resource tools, essential documents, monitoring plans and report templates
• Develop and manage multidisciplinary project team members
• Organize, plan for, and produce minutes for project team meetings
• Ensure the overall quality of project services and deliverables
• Provide necessary updates and reports to the sponsor as outlined by the contract
• Plan and oversee the execution of investigator meetings as contracted
• Work with the Business Development team on budgets, proposals and change orders
• Ensure both CPC and sponsor are aware of and in agreement on any change in project scope that has a financial or resource impact
• Provide Head of Trial Master File scope of services to enable him/her to establish and maintain Trial Master Files (TMFs) and project document files, both electronic and paper
• Adhere to local, federal and international regulations, guidelines and CPC Policies, Standard Operating Procedures (SOPs) and Work Instructions (WIs)
• Use appropriate discretion to proactively identify when there is a need to deviate from policies, procedures or plans and ensure deviations are appropriately documented
• Define and monitor Endpoint and Specialty Services scope, timelines and deliverables from project initiation to closeout with assistance from study assigned Clinical Operations Manager and the Head of Endpoint and Specialty Services
• Manage contracted deliverables for external committees (e.g. data safety monitoring boards, clinical endpoint committees), including but not limited to meeting scheduling, generation of meeting minutes and distribution of meeting materials
• Oversee SAE process and assure execution of safety plans
• Accurately track receipt, entry, upload and the processing of photos, acetate tracings, and other source documents submitted from sites
• Contact appropriate individuals (e.g., study site staff or study site Clinical Research Associate) regarding incomplete, inaccurate, or missing photos, acetate tracings, and other Endpoint and Specialty Services Core Lab documents as required by the project
• Oversee timely and accurate entry and cleaning of data for all study databases; maintain and file data management documentation as required
• Provide feedback to study sites on tracing and quality issues, as required by project
• Manage and conduct Endpoint and Specialty Services CPC Core Lab activities
• Provide operational support for the biostatistics and programming deliverables

Clinical Operations Manager II

Research Analyst

• Contact study sites and schedule SEEVs as assigned.
• Coordinate travel arrangements for domestic and international SEEVs.
• Conduct SEEVs domestically and internationally, including hands-on training with site staff on endpoint data collection, source document/reference tools review for endpoint data and equipment assessment according to the CPC SOP.
• Complete detailed, accurate, and timely SEEV reports and communicate findings to internal study teams.
• Escalate site concerns identified during SEEVs to the appropriate Clinical Trial Manager or Project Manager.
• Assist Clinical Trial Managers and CRAs with enrollment and retention escalations for international sites.
• Support tracking of study recruitment and enrollment metrics for sites requiring additional intervention.
• Communicate with site staff to resolve issues related to missing, incomplete, or inaccurate submissions.
• Participate in discussions related to site compliance, performance trends, and corrective actions.
• Serve as a supporting contact for site questions when CRAs or CTMs are unavailable.
• Assist with review and maintenance of site regulatory and study documents.
• Help ensure accurate documentation in CTMS, TMF, and other study systems.
• Participate in project team meetings and contribute to site issue resolution.

Project Manager, Business Development

Clinical Operations Manager II

Clinical – Endpoint Research Associate