Project Lead – Project Manager, FSP

Role Overview

• The Project Manager serves as the Project Lead and primary sponsor contact and is accountable for the overall delivery of the project (quality, time, cost) on behalf of the organization.
• Additionally, the Project Manager establishes and communicates customer expectations to the project team and ensures that escalation pathways are adhered to internally and externally.
• The role involves leading the cross functional project team to meet or exceed deliverables.
• Manages the day-to-day execution of assigned trials to ensure completion of established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements.
• Supports the Clinical Trial Lead in the development of specific study plans, development of core study documents, and systems set-up to ensure operational excellence in execution of the clinical trial protocol.
• Develops required study specific training materials, including supporting the coordination of Investigator meetings.
• Leads and chairs meetings with QSDO team members, including representatives from CTDU, CTAU and CSO to ensure the successful delivery of site activation and recruitment targets and evaluation recruitment strategies.
• Provide accurate and up-to-date trial information in relevant tracking systems and provide regular updates of trial progress, issues, and risks to key SMT stakeholders during regularly scheduled meetings.
• Depending on study needs, manage third-party study vendors including study specification creation, collection, and finalization in conjunction with the relevant functional SMEs.
• Proactively identifies and resolves issues that arise during trial conduct, managing the escalation of trial-related issues.
• Participates in and/or facilitates cross-functional collaboration and problem solving to ensure risk mitigation.
• Supports the team to ensure timely data cleaning, data analysis and the availability of top line results.
• Ensure project deliverables meet quality standards.
• Ensures compliance with relevant sponsor policies and procedures.
• Works with the Study Vendor Specialist to define project study specs during vendor setup.
• Facilitate effective communication and collaboration among team members.
• Adheres to project budgets, ensure timely billing and invoicing.

Requirements

• B.A. or B. Sc. in a scientific discipline.
• 6 + years in clinical operations management, managing clinical trials per quality, timeline, and budget expectations, preferably with a Sponsor company and a CRO.
• Related scientific and clinical expertise and exceptional project-management, risk-assessment, contingency-planning, and communication skills.
• Extensive knowledge of clinical development related to one or more trial phases (I, II, III), as well as cross-functional drug development.
• Expertise in Good Clinical Practices (GCP), International Council for Harmonization (ICH) guidelines and regulatory requirements for clinical development.
• Ability to establish and execute operational plans.
• Technical and systems competency, such as computer skills, to include effective use of systems and applications such as Microsoft Outlook, Word, Excel and PowerPoint, as well as organization systems.
• Ability to delegate and effectively prioritize own and workload of project team members in a frequently changing environment

Tech Stack

• Google Cloud Platform

Benefits

• Competitive salary
• Flexible working hours
• Professional development opportunities