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PROJECT MANAGER ENGINEER II

At TE, you will unleash your potential working with people from diverse backgrounds and industries to create a safer, sustainable and more connected world.

Job Overview

TE Connectivity’s Engineering Project Management Teams manage cross functional engineering projects. They work with Product Management, Sales, Quality, Manufacturing, Finance, and other functions across TE to assure projects meet financial, schedule and customer expectations. They are responsible for defining and creating project schedules, portfolio management, communication and execution of programs, identifying resource constraints and working with management for resolution, while adhering to LeanPD processes.

The Project Manager Engineer (PME) is responsible for the management of all aspects of Clinical Study Team activities for assigned project(s). The PME in concert with the Director of Clinical Programs, is accountable for achieving successful delivery of clinical team activities at the project level by meeting client’s requirements according to time, quality/scope and budget constraints.

Responsibilities:
• Manage the full scope of Clinical Studies including, but not limited to timeline, budget, and project milestones.
• Lead and support cross-functional study teams and facilitate team meetings as needed to move clinical activities forward.
• Serve as the main contact and liaison for client to provide weekly updates.
• Track and report progress of sites including subject screening/enrollment, data collection, and identify study-related issues, confi rm resolution,
and ensure proper documentation through Toolbox Event system.
• Assess the qualifi cation of potential investigative sites, initiate clinical trials at investigative sites, instruct site personnel on the proper conduct
of clinical trials, and close clinical trials at investigative sites.
• Serve as technical lead. Research and learn project indication.
• Generate clinical study documents such as Protocols, ICFs, Source Documents, Site Operation Manuals, and Monitoring Plans and ensure the maintenance of
essential documents in TMF including transfer to Client.
• Review and verify accuracy of clinical study data collected, either onsite or remotely. Provide regular site status information to team members, trial management,
and update trial management tools.
• Ensure completion of monitoring activity documents as required by Toolbox SOPs or other contractual obligations.
• Perform essential document and Trial Master File reconciliation. Perform source document verifi cation and query resolution.
• Work with the CRAs assigned to the project to ensure SIVs, IMVs and SCVs are scheduled appropriately. Review and approve CRA reports.
• Work the Clinical Project Coordinator on start-up activities including site contracts and budget negotiation.
• Work with Data Management in the query resolution and validation process and ensuring timely database lock.
• Work with Clinical Supplies in the management of Investigational Product (IP) and ancillary supplies.
• Assess IP accountability, dispensation, and compliance at the investigative sites.• Ensure all required project-related training is completed and documented.
• May be assigned additional Clinical Operations tasks.
• Help create a fun, rewarding and collaborative environment.

What your background should look like:

Education/Skills:
• Bachelor’s degree; advanced degree (Master’s or above) preferred.
• Certification CCRP or CCRA is a plus but not required.
• Experience as a CRA including the ability to interact eff ectively with investigators and cross-functional teams;
• In vitro diagnostics (IVD) experience is preferred.

Competencies

Values: Integrity, Accountability,Teamwork, Innovation

COMPENSATION
•    Competitive base salary commensurate with experience: $71 - $107K (subject to change dependent on physical location)
•    Posted salary ranges are made in good faith. TE Connectivity reserves the right to adjust ranges depending on the experience/qualification of the selected candidate as well as internal and external equity.
•    Total Compensation = Base Salary + Incentive(s) + Benefits
BENEFITS
•    A comprehensive benefits package including health insurance, 401(k), disability, life insurance, employee stock purchase plan, paid time off and voluntary benefits.

EOE, Including Disability/Vets

Location: 

Carlsbad, CA, US, 92008

City:  Carlsbad
State:  CA
Country/Region:  US
Travel:  25% to 50%
Requisition ID:  91141
Alternative Locations: 
Function:  Engineering & Technology


Nearest Major Market: San Diego

Job Segment: Project Manager, Engineering Manager, Manufacturing Engineer, Project Engineer, Equity, Technology, Engineering, Finance

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