Senior Project Manager

About this role

Catalyst Clinical Research provides customizable solutions to the biopharmaceutical and biotechnology industries through Catalyst Oncology, a full-service oncology CRO, and multi-therapeutic global functional and CRO services through Catalyst Flex. The company's customer-centric flexible service model, innovative technology, expert team members, and global presence advance clinical studies. Visit CatalystCR.com.

As a Senior Project Manager you are a key member of the Development Operations, Project Management Team. You are accountable for achieving successful delivery of clinical trial team activities at the trial/program level by meeting contractually agreed sponsor and regulatory requirements according to Scope of Work (SOW) and agreed upon timelines. You will lead and direct cross functional teams and understand/manage sponsor expectations. You will proactively identify, resolve/mitigate, and escalate risks and/or issues.

Position Responsibilities/Accountabilities:

• Responsible for planning, tracking and delivery of efficient and high-quality trial execution of all operational aspects of assigned clinical trials/programs (can be more than one) from protocol inception through Clinical Study Report and trial close out.
• Responsible to manage and drive the SOW consistent with the targeted timelines and budget for the assigned clinical trials/programs.
• Responsible for communication to the sponsor with strict attention to budget and timeline estimates for deliverables and timely notification of changes to SOW and timelines.
• Responsible for timely communications to the sponsor on all aspects of the study with a priority on communicating any patient safety issues.
• In collaboration with the trial/program team and all stakeholders ensures the completion of all project deliverables from contract signature to delivery of final clinical study report and project close out complying with ICH GCP requirements.
• Responsible to manage study vendors, patien...