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Clinical Project Manager


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.

What your background should look like:


The Clinical Project Manager (CPM) is responsible for the management of all aspects of Clinical Study Team activities for assigned project(s). 
The CPM, 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, confirm resolution, 
    and ensure proper documentation through Toolbox Event system.
•    Assess the qualification 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 verification 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.

 

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 effectively with investigators and cross-functional teams; 
    in vitro diagnostics experience is preferred.


 

 

 

 

Competencies

Values: Integrity, Accountability,Teamwork, Innovation

About TE Connectivity

TE Connectivity is a global industrial technology leader creating a safer, sustainable, productive, and connected future. Our broad range of connectivity and sensor solutions, proven in the harshest environments, enable advancements in transportation, industrial applications, medical technology, energy, data communications, and the home. With more than 85,000 employees, including over 8,000 engineers, working alongside customers in approximately 140 countries, TE ensures that EVERY CONNECTION COUNTS. Learn more at www.te.com and on LinkedIn, Facebook, WeChat and Twitter.

What TE Connectivity offers:
We offer competitive total rewards compensation. Our commitment to our associates includes offering benefit programs that are comprehensive, competitive and will meet the needs of our associates.

  • Generous 401(k) Plan
  • Tuition Reimbursement
  • Benefits start on day one
  • Charity Donation Matching Program
  • Competitive Paid Time Off
  • Employee Resource Groups
  • Employee Stock Purchase Program
  • Healthcare for Associates and Families
  • Health and Wellness Incentives
  • Life Insurance and Disability Protection

Throughout our Global reach and various Business Units, we take a balanced approach to the benefits we provide. Many benefits are company-paid, while others are available through associate contribution. Specific benefit offerings can vary by location.

 

EOE, Including Disability/Vets

Location: 

Carlsbad, CA, US, 92008

City:  Carlsbad
State:  CA
Country/Region:  US
Travel:  10% to 25%
Requisition ID:  80444
Alternative Locations: 
Function:  Engineering & Technology


Nearest Major Market: San Diego

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