Project Lead/Project Manager - FSP

Thermo Fisher Scientific•Morrisville, NC

1d•Onsite

About The Position

Join Us as a Project Lead/Project Manager - Make an Impact at the Forefront of Innovation. 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. As part of the Study Management Team (SMT), is accountable for the implementation and execution of study plans to support successful clinical trial delivery, including the following: • 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. Refer Study Vendor Specialist Job Description. • 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
Effective oral and written communication and presentation skills
Proactive, solutions oriented and adaptable to changing priorities and situations

Nice To Haves

An advanced degree in a related field.
Investigator site and/or monitoring experience.
Functional Service Provider (FSP) experience.

Responsibilities

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.