Job Type

Full-time

Description

JOB SUMMARY

The Corelab Project Manager oversees and coordinates the operational aspects of ongoing Corelab data projects to ensure that the client's goals of time, cost, and quality are met. The Corelab Project Manager is also responsible for driving process improvements within the Corelab project management function that supports overall data services goals.

RESPONSIBILITIES

• Serve as Corelab Project Manager: primary contact for sites, sponsors, and CROs regarding overall study conduct, quality, timelines, and budget. Provide support and act as the primary contact to the Sponsor, CROs, vendors, clinical sites, data management, and scorers for questions regarding Corelab Project activities.
• Serve as Lead to Corelab Project Management team to ensure the successful conduct of Projects following ICH/GCP and internal SOPs. Provide leadership and guidance to Project Managers, Data Coordinators, and other Corelab staff as requested.
• Serve as the primary lead for guidance, oversight, and status database tracking for all Corelab Project archives.
• Responsible for tracking and managing assigned project budgets, change orders, and budget reconciliations.
• Responsible for development, oversight, tracking, study documentation and plans, communication, and support of all project-related activities in collaboration with the study management team from start-up to closeout.
• Oversee, coordinate, and manage project and site status trackers, formulating and overseeing solutions for follow-up action as warranted.
• Evaluate and analyze data submitted by various parties to ensure it meets the criteria set by the study protocol.
• Identify areas in which resources or progress are not consistent with project plans and formulate corrective action plans and solutions.
• Contribute to the development of internal and study-specific SOPs.
• Develop presentations and training materials as requested.
• Contribute and/or coordinate training activities for team members or investigative sites.
• Monitor and update study and certification databases to ensure that all data is accurate and being processed on time.
• Perform data entry and quality control tasks, including generating and tracking queries and overseeing query resolution.
• Provide weekend coverage, as needed and assigned.
• Perform Corelab study-related setup, configuration, and UAT.
• Follow and ensure compliance with current Good Clinical Practices.
• Adhere to corporate policies and procedures.
• Other duties as assigned.

TRAVELING

Attend client meetings as needed and other locations as required by the role when necessary.

Salary Range: $65,000-$100,000 annually. Final compensation is based on skills, experience, location, and overall expertise.

Requirements

• The position requires at least 2 years of experience in a Project Manager role and/or comparable roles, and a minimum of 2 years of experience in clinical research experience in a CRO, pharmaceutical or biotechnology company, or Corelab project and data management. A bachelor's degree in life sciences is strongly preferred.
• The position requires project management experience and a skill set for developing project documents, site standard operating procedures, and study-specific SOPs.
• Demonstrated knowledge and a clear understanding of the overall Corelab project and data management process, including study site certification, study startup procedures, device management, and support, study conduct, query reconciliation, database lock, final archive process, report generation, and data transfer.
• Must have proficiency with ICH/GCP guidelines.
• Strong communication, organization, time management, customer service, and interpersonal skills are required.
• Excellent leadership, influencing, and collaboration skills are expected.
• Strong computer (Microsoft Windows and Microsoft Office Applications) are required