Clinical Project Manager (m/f/d) - sponsor decicated

Recognise potential challenge within the protocol and operational aspects of the trial and escalate to manager as appropriate.

Maintain a strong knowledge of the protocol to be able to answer standard operational questions from monitors, sites, and local internal personnel.

In liaison with the global clinical team, assist in the development of local trial execution plan and timeline commitments for a country/cluster.

Ensure that study start-up activities and any amendments are conducted and completed on time, including preparation of IRB/EC submission packages, working with regulatory affairs for Health Authorities submissions.

Monitor the status of site budget and contract negotiations as well as the collection and review of essential documents.

Ensure sites are prepared for “Ready to Initiate Site” (checkpoint). Obtain written confirmation about availability of global documents.

Ensure that all documentation in place for initial and subsequent drug release in collaboration with the local Qualified Person.

Provide training as needed for monitors and any other activities that support site readiness to recruit.

Ensure documentation of training (global/regional/local IM minutes, participants’ lists, certificates, etc.) is archived appropriately.

Drive the conduct of the trial, track and oversee progress and status.

Ensure all operational aspects are on schedule.

Oversee local clinical team activities to achieve trial timelines and quality execution according to client standards and local and international regulations.

Consistently read/review the content of all monitoring visit reports for the assigned trial to identify trends and issues. Appropriately escalate issues in a timely manner and ensure resolution.

Communicate with field monitors on a regular basis to assure proper adherence to protocol, timelines and other trial related topics.

Lead and chair local study team meetings, attend and participate in global clinical trial team meetings.

Track trial budget with appropriate trial budget responsible in country. Oversee TCF preparation and submission to COM in collaboration with the TCF specialist in the country.

Keep oversight of country level data management activities, including timely resolution of data entry issues, screen failure reasons, discontinuation rates, patient profiles, and proactively identify data entry issues to mitigate queries.

Accountable to keep reporting systems up to date: ClinAdmin, TMF, CREDI... throughout trial conduct

Ensure that all trial closeout activities are performed, in close cooperation with field monitors and clinical trial head.

Oversee local vendor selection and performance as needed. Serve as main contact for any potentially The following CSM accountabilities could be transferred to CRA Group Head depending on local organisation:

Support trial feasibility and CPO patient commitments in cooperation with the relevant line units: ensure two-way feedback on feasibility between global team and country.

Coordinate and manage the site selection process in collaboration with the necessary line units.

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