Clinical Project Manager III/ Senior CPM (level dependent on experience)

Serve as client contact at project operational level.

Provide oversight to contracted vendors; review contracted specifications and maintain regular interactions with vendors to ensure meeting timelines and expectations. Provide oversight and management of third-party vendors’ financial spend.

Closely reviews and assesses trial’s KPI to ensure project progressing in a positive manner and actively works with team to mitigate activities that are outside the expected ranges.

Provide oversight of appropriate project tracking using computer-assisted programs and ensure timely entry of project information by all trial team members to enable accurate reporting to clients and CTI executive management.

Monitor ongoing resource needs to the project; keep appropriate functional department heads apprised of any identified resource needs or performance issues.

Ensure that the assigned clinical trial team receives appropriate training to facilitate effective implementation, conduct and execution of the protocol.

Provide oversight of Clinical Research Associate (CRA) tasks on assigned projects; provide oversight of the CRA’s management of sites and monitoring of the clinical trial data; review and approve site trip reports and escalate site issues as needed to trial assigned Director, CTI executive management and/or client/sponsor in accordance with the trial’s Project and Communication Plan

Attend site visits on an as-needed basis to provide support to the trials, CTI staff and/or site staff.

Lead client and team meetings to enable effective information sharing, discussion, and decision-making; ensure accurate and complete documentation of the meeting discussions, decisions and outcomes.

Prepare or provide oversight/approval of project status reports for assigned projects.

Participate and provide oversight in the planning of Investigator meetings; develop and/or approve meeting agendas or related materials and conducts presentations.

Ensure completeness of the TMF through management and maintenance of the TMF for assigned studies ensuring that all trial assigned staff regularly submit documents and complete regular audits of the TMF to ensure accuracy and completeness as defined in the trial’s TMF Plan.

Participate in business development activities as requested (RFP development, bid defense presentations, client meetings etc.).

Suggest, participate in and/or lead process improvement activities and initiatives.

Mentor other CPM staff.

As required per region, review site and vendor invoices, approve subject milestones payments per scope; assist in the preparation of payment projections, and in the maintenance of payment records per regional needs. Support or conduct site budget negotiation for sites in their region as needed.

In the EU, preparation and negotiation of site budgets, site payments and payment of site invoices are handled by the EU Clinical Trial Budget Management Team with the assistance of regional CRAs or Study Start-up Specialists to support country specific language communications.